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What to decide before you file a product in a new market
A registration and renewal planning framework
By Soumya Mahapatra
The first registration in a new market is a project. The twentieth is a portfolio. Somewhere between the two, a handful of decisions get made — usually by whoever opened the first dossier, usually without anyone naming them as decisions — and every one is far cheaper to make than to unmake.
This piece is about those decisions — not the submission content, but the structural choices sitting underneath it that constrain everything filed afterward.
The default is a decision too
Each of these gets settled whether or not anyone settles it deliberately. The distributor who offers to "take care of the registration" has settled the ownership question. The associate who copies the CE technical file into the new dossier has settled the base-approval question — and, in several markets, the timeline.
Nobody did anything wrong. Each made a reasonable local choice in the absence of a portfolio-level one. The cost lands three years later, on someone else.
1 · The entity structure: who manufactures, and who represents you
The legal manufacturer. In a group with several legal entities, this is usually chosen for administrative convenience — whichever entity holds the quality system certificate, or whichever the first submission is named. That entity then propagates: onto the declaration of conformity, the label, every subsequent registration, and the import documentation.
Changing it later is generally not an amendment. Several authorities treat a change of legal manufacturer as a change of applicant, which restarts the application rather than modifying it.
A legal-manufacturer change cannot reliably be classified by market alone. The decisive distinction is whether the existing legal entity changes its name/address or a different legal entity assumes the manufacturer/registrant role.
For the three important jurisdictions, the provisions support the following:
Market / regulatory layer | Same legal entity: name or address change | Different legal entity assumes responsibility | Relevant provision |
US — FDA establishment registration | Update. Registration information must be updated within 30 days. | The new owner/operator must satisfy its own registration obligations. A previously unregistered owner/operator entering a regulated operation must initially register; an existing registrant must update the affected information. Part 807 does not establish a blanket requirement for a new device application because ownership changes. | 21 CFR 807.22(a), (b)(2); 807.25(b) identifies establishment and owner/operator information. |
US — FDA device listing | Update the affected listing information. | List under the new owner/operator and update/delete the former owner’s listing as applicable. FDA’s ownership-transfer instructions distinguish these actions from obtaining a new clearance. | 21 CFR 807.22(b)(3)–(4), 807.25(g); FDA’s Transfer of 510(k) Ownership instructions expressly require both owners to update registration/listing. |
EU — MDR manufacturer obligations and certification | Administrative updates, with notified-body involvement where applicable. | The incoming manufacturer must establish compliance in its own capacity. Article 10 does not itself say every manufacturer change requires a “new application.” For devices requiring a notified body, certification must cover the incoming manufacturer; the certification route must be resolved with that body. Ordinary self-declared Class I devices have no notified-body application. | MDR Article 10(4), (6), (7), (9): technical documentation, conformity assessment/declaration, registration and QMS. Annex IX §2.1 requires the manufacturer’s QMS assessment application to identify that manufacturer. Article 52 governs the applicable conformity-assessment route. (eur-lex.europa.eu) |
China — NMPA Class II/III registrant changes | Change filing (变更备案) within 30 days for registrant name/address changes. This is distinct from technically reviewed change registration. | Do not treat replacement of the registrant as an ordinary name-change filing. The cited national provision does not expressly authorize transfer to a different legal entity—and does not, by itself, prove that every merger or succession requires fresh registration. A universal “new application” classification remains unconfirmed. | SAMR Order No. 47, Article 79 distinguishes name/address filings from change registration; Article 81 provides that the amendment document accompanies the original certificate and retains its expiry. State Council Order No. 739, Article 16 establishes the registration application routes. (english.nmpa.gov.cn) |
The test: assume a corporate reorganization in five years. Name the entity that survives it.
The in-country representative. Most markets require someone inside the jurisdiction to carry regulatory responsibility for a foreign manufacturer. The role has a different name and a materially different scope in each market. Below section highlights the distinctions across some major markets:
European Union — authorized representative (AR)
MDR Article 11(1)–(3) requires a manufacturer established outside the EU to designate a sole AR. The mandate becomes valid when the AR accepts it in writing and must cover at least the same generic device group.
Article 11(3) specifies minimum duties, including document availability, verification of registration, cooperation with authorities and complaint forwarding. Article 11(5) establishes joint and several liability for defective devices where its stated conditions apply.
Article 12 requires a change agreement between the manufacturer, incoming AR and, where practicable, outgoing AR. It must address: mandate end/start dates; the last date the outgoing AR may appear in manufacturer-supplied information, including promotional material; document transfer, confidentiality and property rights; and continued forwarding of suspected-incident complaints after termination.
Residency follows Article 2(32): the AR must be established within the Union. Instrument: Regulation (EU) 2017/745, 5 April 2017, consolidated version 19 July 2026.
United States — US Agent and official correspondent
Function | Governing provision | Scope |
US Agent | 21 CFR 807.40(b) (1)–(2) | Must reside or maintain a place of business in the US. Assists FDA communications, product questions and inspection scheduling; receipt of FDA documents can constitute receipt by the foreign establishment. |
Official correspondent | 21 CFR 807.40(a); 807.25(e) | Handles establishment-registration and device-listing communications and submissions. The role does not itself carry the US Agent’s residency requirement. |
Section 807.40(b) expressly permits the US Agent also to be an official correspondent. Section 807.40(b)(3) requires changes to the agent’s name, address or telephone number to be reported within 10 business days. The section’s latest amendment identified in its source note is 2 August 2012. FDA’s current operational guidance confirms the distinction and requires the nominated agent to confirm consent.
Japan, Korea, Saudi Arabia and China each require their own construct, with different liability, different residency requirements, and different consequences on change.
Market | Specific role, residency and responsibility | Consequences of change | Governing instrument and date |
Japan | Marketing Authorization Holder (MAH; 製造販売業者), or Designated MAH (DMAH; 選任外国製造医療機器等製造販売業者) under the foreign-special-approval route. Both require an appropriately licensed Japanese MAH. Under that route, the foreign approval holder retains the approval and appoints the DMAH for domestic quality and safety responsibilities. | Article 23-2-18 requires notification of DMAH replacement or specified information changes within 30 days. Changing a domestic MAH holding the approval is a different transaction: Article 23-2-11 provides for approval succession and associated records/information transfer. | PMD Act, Act No. 145 of 10 August 1960: Arts. 23-2, 23-2-17 and 23-2-18. Relevant recent amendment: Act No. 37, promulgated 21 May 2025, with phased commencement; the cited e-Gov text includes a 12 June 2026 version. (pmda.go.jp) |
South Korea | Licensed importer (수입업자) holding the relevant product import authorization, certification or notification. “Korean License Holder” is useful industry shorthand; Article 15 identifies the statutory construct. It requires a Korean import business with the applicable facilities and quality-management arrangements. | Article 47(1), (3) provides succession for qualifying business transfers/mergers, including transfer of the business associated with an authorized, certified or notified product. Replacing a commercial representative alone does not transfer that regulatory status. | Medical Devices Act (의료기기법), Arts. 15 and 47. Official current text reviewed: Act No. 22105, amended and effective 20 October 2026. (조문정보) |
Saudi Arabia | SFDA-licensed authorized representative, located in the Kingdom, with a manufacturer agreement and an AR license for each manufacturer represented. Responsibilities include post-market surveillance and documented performance of delegated regulatory tasks. | Implementing Regulation §15.2 requires the manufacturer to appoint a replacement and transfer previous obligations immediately upon termination/non-renewal, and notify SFDA. This is an express continuity requirement. | Medical Devices Law, Royal Decree M/54, 6/7/1442 AH; Article 15, implemented by Board Decision 3-29-1443, 19/2/1443 AH. Operational requirements: MDS-REQ9, version 2.0, cover date 15 January 2025, §B.2. (sfda.gov.sa) |
China | Domestic agent (境内代理人 / 代理人): a designated enterprise legal person established in China. It assists the overseas registrant/filer with registration, lifecycle obligations and implementation of legal responsibilities. Article 98 provides direct administrative penalties for failure to perform its obligations. | Agent particulars fall within the change-filing framework of Order 47, Article 79. Agent replacement also requires updating relevant systems; NMPA’s UDI guidance expressly provides a registration/filing-certificate agent-change application. The overseas registrant remains distinct from its domestic agent. | Regulations on Supervision and Administration of Medical Devices, Order 739, Arts. 20 and 98, revised 6 December 2024; Registration and Filing Measures, SAMR Order 47, Arts. 14 and 79, promulgated 26 August 2021, effective 1 October 2021. (samr.gov.cn) |
The point underneath all of it: the representative role and the distribution role are separable, and separating them is almost always worth the cost. When one company both sells your device and carries your regulatory responsibility, market access is a term of a commercial contract.
2 · Who holds the registration — and what happens when the relationship ends
This is the most expensive decision on the list, and the one most often made by default.
In some markets the certificate is issued in the manufacturer's name, with the local representative named alongside. In others it is issued in the name of the local entity — importer, distributor, registration holder. In the second case the registration is that company's asset, and if the relationship ends you may not be able to take it with you.
Brazil is the example practitioners cite: the registration sits with a Brazilian holder, the locally authorized manufacturer or importer, and moving it is procedurally heavy.
The consequence is not a delay. It is that changing distributors means re-registering — clock restarted, fees paid again, and no legal route to market in the interval while a competitor has one. Three things to settle in the contract before the first filing:
Transfer on termination. The holder assigns the registration to the manufacturer or its nominee, at no cost, on termination for any reason, by a stated deadline.
Decoupling of exclusivity. Distribution exclusivity and registration holding are separate grants with separate terms. Bundled, you renegotiate market access every time you renegotiate price.
Data access. The holder provides the full as-filed dossier, all correspondence with the authority, and the current certificate, on request. Often nobody at the manufacturer holds a copy.
Relationship map of four roles in a market registration — legal manufacturer, in-country representative, registration holder and distributor — showing which contractual ties can be severed without refiling and which cannot.
3 · Which base approval you leverage
Many markets shorten review for devices already approved in a jurisdiction they treat as a reference. The shortening is not uniform, and the tier a market sits in determines whether the base approval removes review from your critical path or only changes the shape of the work.
Four tiers, most reliance to least:
Complete reliance — the foreign approval is accepted. No additional assessment.
Registration only — local registration granted on the strength of the foreign certificate, without technical review.
Partial reliance — expedited assessment. Limited review keyed to the certificate, scoped to local regulatory requirements rather than full technical evaluation.
Adapted reliance — the certificate is the basis, with modifications or supplementary local requirements on top.
A fifth case is worth naming, because two of the four markets below fall in this category: no certificate reliance. The foreign approval is evidence, not a pathway.
Market | Tier and class scope | What prior foreign approval can remove or reduce | What remains on the critical path | Published authority review/processing time |
Saudi Arabia — SFDA | Conditional reliance alongside a full assessment route. Classes A–D, subject to eligibility and exclusions. | Eligible prior approvals can reduce documentation and duplicate assessment. This is not universally “registration only.” | Saudi requirements, local representation/licensing, QMS, application completeness and any additional information requested. | Reliance: 35–60 working days for each of Classes A, B, C and D, for complete eligible applications. (sfda.gov.sa) |
Brazil — ANVISA | Optimized technical review for eligible Class III–IV registrations, including IVDs. Classes I–II use notification, outside this mechanism. | ANVISA may use an equivalent authority’s assessment to abbreviate its review. The Brazilian dossier remains required, and optimized review does not change queue order. | Local holder, applicable dossier and language requirements, Brazilian requirements, GMP certification where required, and queue position. | I–II: routine notification processing up to 30 days. III–IV: published legal analysis periods are by product type: 250 days equipment; 320 days materials; 365 days IVDs. No separate guaranteed optimized-route deadline verified. (IN nº 290, de 04/04/2024) |
Korea — MFDS/NIDS | No general foreign-certificate substitution in the ordinary product route; evidence reuse. I: notification; II: generally certification, with specified exceptions requiring approval; III–IV: approval. | Acceptable overseas reports can support the Korean assessment. Foreign approval itself does not establish an abbreviated foreign-certificate route. | Korean submission and assessment, licensed importer, applicable testing/clinical evidence and KGMP. | II certification: 5 days for the certification step, excluding preceding technical review. Approval cases, including III–IV: 65 days with technical-document review; 80 days with clinical-data review; 10 days where technical review is unnecessary. No quantified Class I target verified here. (Ministry of Food and Drug Safety) |
Japan — MHLW/PMDA | No general foreign-certificate substitution in the ordinary Japanese route. I: notification; II–III: certification where applicable standards exist, otherwise approval; IV: approval. | Foreign evidence can support the application; foreign approval does not replace the Japanese notification, certification or approval. | MAH/DMAH arrangements, applicable Japanese assessment, evidence requirements and QMS procedures. | Approval targets are by review category, not risk class: new devices 14 months, priority new 10; improved devices 10 with / 6 without clinical data; generic devices 4. These are PMDA approval-cohort performance targets, not individual guarantees. No universal notification/certification target verified. (Pharmaceuticals and Medical Devices Agency) |
Three consequences follow for these markets, and none of them are obvious at the time.
Timing is inherited. Under registration-only and partial reliance the base approval is a gate, not an accelerant: the dependent filing cannot start until the base certificate exists. Sequencing is therefore a base-approval decision. Top-tier markets queue behind whichever base you pick; a no-reliance market like Japan can run in parallel from day one.
Scope is inherited. Your registration abroad generally cannot be broader than the base it leans on. If your CE certificate covers three models and your FDA clearance five, the base you cite decides which two you cannot sell.
Validity is inherited. Foreign approval status requires continued monitoring. Safety-related restrictions can trigger local reporting, corrective action and regulatory reassessment, even where the local authorization remains legally independent. Administrative expiry and commercial withdrawal must be assessed separately against the applicable route and authorization conditions.
Which changes trigger a new submission where it is worked through in our decision framework for when a device change requires a new submission.
The test: pick the base whose change cadence you can absorb, not the one that clears fastest. A base that saves weeks in Riyadh and generates four change notifications a year has saved you nothing.
4 · How the device family is defined
You decide which SKUs, models, sizes and configurations travel together on one registration. Grouping rules differ by market, and a grouping accepted in one place may require separate applications in another. Canada’s statutory term is “system”, and the list also includes medical device family, medical device group, medical device group family, and test kit.
Singapore permits qualifying families of systems, whereas Brazil’s RDC 556/2021 framework for medical materials prohibits them. Keep that Brazilian scope qualification: orthopedic implants are excluded from RDC 556, and equipment grouping follows RDC 542/2021 rather than the same materials rules.
Group too narrowly and you can multiply application fees and the work of maintaining separate authorizations. Group too broadly and the authority may reject the grouping, requiring separate applications. A shared licence can also widen the consequences of a suspension, although an adverse finding does not automatically affect every family member.
Canada and Singapore permit qualifying additions through amendments or change notifications; Brazil also permits additions within eligible existing groupings. Changing the grouping after approval can mean an amendment, a change notification or a new application, depending on the market and whether the revised grouping still meets its rules.
The test: group by what changes together, not by what sells together. A family assembled from a price list is a liability.
5 · What the label carries
One label used everywhere, or a label per market. The trade is symmetrical: a global label does not automatically mean one artwork change becomes a change notification in every jurisdiction you sell in; a label per market means N artwork revisions and N change controls. Some administrative label changes require only internal change control; some local details can appear on a supplementary label or accompanying document.
A shared label can create shared implementation work, while market-specific information can sometimes be maintained through local overlabels or accompanying documents. Whether a label change requires regulatory filing depends on its content, the affected regulatory records and the market’s change rules.
The detail that catches people: if the importer or local representative address appears on the label, changing importer is an artwork change — and an artwork change is a regulatory change in some jurisdictions.
The test: decide language scope by the smallest unit of change, not by translation cost. Translation is a quote; change control is a permanent liability.
Renewal is a decision, not a task
Renewal cycles are market data and they move. What is durable is who owns the obligation.
Registrations expire on a date set years earlier by someone who has since changed roles, and the first signal is often a customs hold. Several markets also require, at renewal, evidence that the device is still marketed in the base jurisdiction — a certificate of free sale or equivalent — with its own lead time and its own owner. Under the higher reliance tiers this is the same dependency as at first filing, arriving again.
However, we must distinguish permission to market from actual commercial sales. An FSC commonly establishes lawful marketability; it does not necessarily prove the device is actively being sold.
Destination market | Foreign-market evidence required at renewal? | Source |
Bahrain — NHRA | Yes. Renewal requires an FSC or Certificate to Foreign Government from the country of origin or a reference country. Separately, the manufacturer must provide a list of countries where the device has been marketed. | Medical Devices Registration Guideline, version 9.1, September 2024, §10, unconditional requirements 2 and 4. Expired or amended supporting documents must also be updated. (nhra.bh) |
UAE — Emirates Drug Establishment | Yes. The published medical-device renewal checklist requires a certificate of free sale/registration issued by the competent authority in the country of origin, plus applicable conformity/marketing-authorization certificates. | EDE’s current service, Renewal of Marketing Authorization for a Medical Device, Required Documents. The checklist does not itself establish a universal requirement that the FSC be newly issued within a particular number of months. (EDE Portal) |
Brazil — ANVISA | Not as a general renewal requirement. The ordinary renewal list requires the imported device’s manufacturer authorization letter and a valid ANVISA GMP certificate. It does not repeat the initial-registration FSC requirement. | RDC 751/2022, Article 27, contrasted with Article 14(IV). Product-specific requirements may add documents. (RDC nº 751, de 15/09/2022) |
China — NMPA | Expressly not required for ordinary imported-device renewal. The renewal requirements state that proof of permission to market in the registrant’s or manufacturing jurisdiction need not be supplied. | NMPA Announcement 121/2021, Annex 6, effective 1 January 2022; the reproduced annex states the exemption explicitly. (beijing.gov.cn) |
Saudi Arabia — SFDA | Route-dependent; a universal renewal FSC requirement is not confirmed. Current reliance guidance requires valid recognized approval and illustrates supplying approval evidence in a renewal application. That supports a dependency for a renewal using that route, not a blanket FSC requirement for every MDMA renewal. | MDS-G030, version 1.0, 9 September 2026, eligibility criteria and application instructions. (www.sfda.gov.sa) |
For certificate procurement, using published service targets, can provide actual visibility into “anticipated” lead times:
Base jurisdiction / issuer | Certificate | Published issuance timing |
US — FDA | Certificate to Foreign Government or other applicable export certificate | 20 working days is the statutory fee-linked processing benchmark described by FDA—not an unconditional delivery guarantee. (FDA) |
UK — MHRA | Certificate of Free Sale | Aims for 10 working days from receipt; busy periods can take longer. (GOV.UK) |
Australia — TGA | Certificate of Free Sale / Export Certificate | Aims for 10 working days. Processing waits for payment; ARTG details must already be correct. (Therapeutic Goods Administration (TGA)) |
Singapore — HSA | FSC / Export Certificate | 14 working days. (Health Sciences Authority) |
Canada — Health Canada | Manufacturer’s Certificate to Export | Current GUI-0097 states there is no service standard. Do not use the 10-business-day figure from the older guidance. (Canada.ca) |
EU member state | FSC under MDR Article 60 | Issued by the relevant member state; Article 60 sets no EU-wide issuance deadline. Confirm the particular national issuer’s timeline. (eur-lex.europa.eu) |
Note: These periods exclude any additional notarization, apostille/legalization and translation. MHRA expressly describes a separate notarization/authentication process where required by the receiving country.
Three things need a named owner on the day the certificate is granted: the date renewal must be initiated, not just the expiry date; the documents it will require and who produces them; and the person notified if the first date passes without the second happening.
The framework
Decision | What happens if nobody decides | Cost to reverse | Lock it before |
Entity structure — legal manufacturer and in-country representative | The entities named in the first filing become the template for subsequent markets | Updates across affected authorizations, contracts and labels. Replacing a legal entity can require transfer, new certification or new registration; a name/address change may follow a simpler route | The first dossier in the first market |
Registration ownership — whose name is on the certificate | The local partner becomes the holder because they handled the filing | A holder-transfer procedure where available; otherwise a new application. Cooperation, fees and transition planning may be needed to avoid an interruption in supply | Contract signature with the local partner |
Base approval — which existing approval supports the chosen route | The team uses whichever approval is easiest to retrieve | Loss of eligibility for the intended reliance route, additional assessment or a revised filing strategy. The claimed scope must meet that route’s requirements | Portfolio sequencing, before dossier scoping |
Device family — what travels on one registration | The regulatory grouping follows the commercial catalogue | An amendment or change notification where the revised grouping remains eligible; a separate application where it does not. Some markets prohibit converting an approved single-product registration into a family | Dossier scoping |
Labeling scope — shared artwork, market-specific artwork or local supplementary labels | The first artwork release becomes the operating model | Artwork revisions, inventory transition and change assessment in each affected market. Notification or amendment depends on what changed and the local rules | Artwork release for the first market |
Renewal ownership — who monitors deadlines and obtains supporting evidence | Responsibility stays with an individual rather than a maintained process | Missed filing windows, possible lapse and a new application where late renewal is unavailable. Supply interruption or a customs hold may follow; required supporting certificates add their own dependencies | Certificate grant, with a named owner, backup and handover process |
What to do Monday
Open a spreadsheet. One row per registration — held and planned. Six columns matching the six rows above, plus a seventh: which reliance tier this market sits in, and which base certificate it depends on.
Fill it from records, not memory. In most portfolios of any age a meaningful share of cells comes back blank, and the blanks are the finding. A registration whose holder you cannot name from a document is one you may not control.
The first registration in a new market is a project. The twentieth is a portfolio. Somewhere between the two, a handful of decisions get made — usually by whoever opened the first dossier, usually without anyone naming them as decisions — and every one is far cheaper to make than to unmake.
This piece is about those decisions — not the submission content, but the structural choices sitting underneath it that constrain everything filed afterward.
The default is a decision too
Each of these gets settled whether or not anyone settles it deliberately. The distributor who offers to "take care of the registration" has settled the ownership question. The associate who copies the CE technical file into the new dossier has settled the base-approval question — and, in several markets, the timeline.
Nobody did anything wrong. Each made a reasonable local choice in the absence of a portfolio-level one. The cost lands three years later, on someone else.
1 · The entity structure: who manufactures, and who represents you
The legal manufacturer. In a group with several legal entities, this is usually chosen for administrative convenience — whichever entity holds the quality system certificate, or whichever the first submission is named. That entity then propagates: onto the declaration of conformity, the label, every subsequent registration, and the import documentation.
Changing it later is generally not an amendment. Several authorities treat a change of legal manufacturer as a change of applicant, which restarts the application rather than modifying it.
A legal-manufacturer change cannot reliably be classified by market alone. The decisive distinction is whether the existing legal entity changes its name/address or a different legal entity assumes the manufacturer/registrant role.
For the three important jurisdictions, the provisions support the following:
Market / regulatory layer | Same legal entity: name or address change | Different legal entity assumes responsibility | Relevant provision |
US — FDA establishment registration | Update. Registration information must be updated within 30 days. | The new owner/operator must satisfy its own registration obligations. A previously unregistered owner/operator entering a regulated operation must initially register; an existing registrant must update the affected information. Part 807 does not establish a blanket requirement for a new device application because ownership changes. | 21 CFR 807.22(a), (b)(2); 807.25(b) identifies establishment and owner/operator information. |
US — FDA device listing | Update the affected listing information. | List under the new owner/operator and update/delete the former owner’s listing as applicable. FDA’s ownership-transfer instructions distinguish these actions from obtaining a new clearance. | 21 CFR 807.22(b)(3)–(4), 807.25(g); FDA’s Transfer of 510(k) Ownership instructions expressly require both owners to update registration/listing. |
EU — MDR manufacturer obligations and certification | Administrative updates, with notified-body involvement where applicable. | The incoming manufacturer must establish compliance in its own capacity. Article 10 does not itself say every manufacturer change requires a “new application.” For devices requiring a notified body, certification must cover the incoming manufacturer; the certification route must be resolved with that body. Ordinary self-declared Class I devices have no notified-body application. | MDR Article 10(4), (6), (7), (9): technical documentation, conformity assessment/declaration, registration and QMS. Annex IX §2.1 requires the manufacturer’s QMS assessment application to identify that manufacturer. Article 52 governs the applicable conformity-assessment route. (eur-lex.europa.eu) |
China — NMPA Class II/III registrant changes | Change filing (变更备案) within 30 days for registrant name/address changes. This is distinct from technically reviewed change registration. | Do not treat replacement of the registrant as an ordinary name-change filing. The cited national provision does not expressly authorize transfer to a different legal entity—and does not, by itself, prove that every merger or succession requires fresh registration. A universal “new application” classification remains unconfirmed. | SAMR Order No. 47, Article 79 distinguishes name/address filings from change registration; Article 81 provides that the amendment document accompanies the original certificate and retains its expiry. State Council Order No. 739, Article 16 establishes the registration application routes. (english.nmpa.gov.cn) |
The test: assume a corporate reorganization in five years. Name the entity that survives it.
The in-country representative. Most markets require someone inside the jurisdiction to carry regulatory responsibility for a foreign manufacturer. The role has a different name and a materially different scope in each market. Below section highlights the distinctions across some major markets:
European Union — authorized representative (AR)
MDR Article 11(1)–(3) requires a manufacturer established outside the EU to designate a sole AR. The mandate becomes valid when the AR accepts it in writing and must cover at least the same generic device group.
Article 11(3) specifies minimum duties, including document availability, verification of registration, cooperation with authorities and complaint forwarding. Article 11(5) establishes joint and several liability for defective devices where its stated conditions apply.
Article 12 requires a change agreement between the manufacturer, incoming AR and, where practicable, outgoing AR. It must address: mandate end/start dates; the last date the outgoing AR may appear in manufacturer-supplied information, including promotional material; document transfer, confidentiality and property rights; and continued forwarding of suspected-incident complaints after termination.
Residency follows Article 2(32): the AR must be established within the Union. Instrument: Regulation (EU) 2017/745, 5 April 2017, consolidated version 19 July 2026.
United States — US Agent and official correspondent
Function | Governing provision | Scope |
US Agent | 21 CFR 807.40(b) (1)–(2) | Must reside or maintain a place of business in the US. Assists FDA communications, product questions and inspection scheduling; receipt of FDA documents can constitute receipt by the foreign establishment. |
Official correspondent | 21 CFR 807.40(a); 807.25(e) | Handles establishment-registration and device-listing communications and submissions. The role does not itself carry the US Agent’s residency requirement. |
Section 807.40(b) expressly permits the US Agent also to be an official correspondent. Section 807.40(b)(3) requires changes to the agent’s name, address or telephone number to be reported within 10 business days. The section’s latest amendment identified in its source note is 2 August 2012. FDA’s current operational guidance confirms the distinction and requires the nominated agent to confirm consent.
Japan, Korea, Saudi Arabia and China each require their own construct, with different liability, different residency requirements, and different consequences on change.
Market | Specific role, residency and responsibility | Consequences of change | Governing instrument and date |
Japan | Marketing Authorization Holder (MAH; 製造販売業者), or Designated MAH (DMAH; 選任外国製造医療機器等製造販売業者) under the foreign-special-approval route. Both require an appropriately licensed Japanese MAH. Under that route, the foreign approval holder retains the approval and appoints the DMAH for domestic quality and safety responsibilities. | Article 23-2-18 requires notification of DMAH replacement or specified information changes within 30 days. Changing a domestic MAH holding the approval is a different transaction: Article 23-2-11 provides for approval succession and associated records/information transfer. | PMD Act, Act No. 145 of 10 August 1960: Arts. 23-2, 23-2-17 and 23-2-18. Relevant recent amendment: Act No. 37, promulgated 21 May 2025, with phased commencement; the cited e-Gov text includes a 12 June 2026 version. (pmda.go.jp) |
South Korea | Licensed importer (수입업자) holding the relevant product import authorization, certification or notification. “Korean License Holder” is useful industry shorthand; Article 15 identifies the statutory construct. It requires a Korean import business with the applicable facilities and quality-management arrangements. | Article 47(1), (3) provides succession for qualifying business transfers/mergers, including transfer of the business associated with an authorized, certified or notified product. Replacing a commercial representative alone does not transfer that regulatory status. | Medical Devices Act (의료기기법), Arts. 15 and 47. Official current text reviewed: Act No. 22105, amended and effective 20 October 2026. (조문정보) |
Saudi Arabia | SFDA-licensed authorized representative, located in the Kingdom, with a manufacturer agreement and an AR license for each manufacturer represented. Responsibilities include post-market surveillance and documented performance of delegated regulatory tasks. | Implementing Regulation §15.2 requires the manufacturer to appoint a replacement and transfer previous obligations immediately upon termination/non-renewal, and notify SFDA. This is an express continuity requirement. | Medical Devices Law, Royal Decree M/54, 6/7/1442 AH; Article 15, implemented by Board Decision 3-29-1443, 19/2/1443 AH. Operational requirements: MDS-REQ9, version 2.0, cover date 15 January 2025, §B.2. (sfda.gov.sa) |
China | Domestic agent (境内代理人 / 代理人): a designated enterprise legal person established in China. It assists the overseas registrant/filer with registration, lifecycle obligations and implementation of legal responsibilities. Article 98 provides direct administrative penalties for failure to perform its obligations. | Agent particulars fall within the change-filing framework of Order 47, Article 79. Agent replacement also requires updating relevant systems; NMPA’s UDI guidance expressly provides a registration/filing-certificate agent-change application. The overseas registrant remains distinct from its domestic agent. | Regulations on Supervision and Administration of Medical Devices, Order 739, Arts. 20 and 98, revised 6 December 2024; Registration and Filing Measures, SAMR Order 47, Arts. 14 and 79, promulgated 26 August 2021, effective 1 October 2021. (samr.gov.cn) |
The point underneath all of it: the representative role and the distribution role are separable, and separating them is almost always worth the cost. When one company both sells your device and carries your regulatory responsibility, market access is a term of a commercial contract.
2 · Who holds the registration — and what happens when the relationship ends
This is the most expensive decision on the list, and the one most often made by default.
In some markets the certificate is issued in the manufacturer's name, with the local representative named alongside. In others it is issued in the name of the local entity — importer, distributor, registration holder. In the second case the registration is that company's asset, and if the relationship ends you may not be able to take it with you.
Brazil is the example practitioners cite: the registration sits with a Brazilian holder, the locally authorized manufacturer or importer, and moving it is procedurally heavy.
The consequence is not a delay. It is that changing distributors means re-registering — clock restarted, fees paid again, and no legal route to market in the interval while a competitor has one. Three things to settle in the contract before the first filing:
Transfer on termination. The holder assigns the registration to the manufacturer or its nominee, at no cost, on termination for any reason, by a stated deadline.
Decoupling of exclusivity. Distribution exclusivity and registration holding are separate grants with separate terms. Bundled, you renegotiate market access every time you renegotiate price.
Data access. The holder provides the full as-filed dossier, all correspondence with the authority, and the current certificate, on request. Often nobody at the manufacturer holds a copy.
Relationship map of four roles in a market registration — legal manufacturer, in-country representative, registration holder and distributor — showing which contractual ties can be severed without refiling and which cannot.
3 · Which base approval you leverage
Many markets shorten review for devices already approved in a jurisdiction they treat as a reference. The shortening is not uniform, and the tier a market sits in determines whether the base approval removes review from your critical path or only changes the shape of the work.
Four tiers, most reliance to least:
Complete reliance — the foreign approval is accepted. No additional assessment.
Registration only — local registration granted on the strength of the foreign certificate, without technical review.
Partial reliance — expedited assessment. Limited review keyed to the certificate, scoped to local regulatory requirements rather than full technical evaluation.
Adapted reliance — the certificate is the basis, with modifications or supplementary local requirements on top.
A fifth case is worth naming, because two of the four markets below fall in this category: no certificate reliance. The foreign approval is evidence, not a pathway.
Market | Tier and class scope | What prior foreign approval can remove or reduce | What remains on the critical path | Published authority review/processing time |
Saudi Arabia — SFDA | Conditional reliance alongside a full assessment route. Classes A–D, subject to eligibility and exclusions. | Eligible prior approvals can reduce documentation and duplicate assessment. This is not universally “registration only.” | Saudi requirements, local representation/licensing, QMS, application completeness and any additional information requested. | Reliance: 35–60 working days for each of Classes A, B, C and D, for complete eligible applications. (sfda.gov.sa) |
Brazil — ANVISA | Optimized technical review for eligible Class III–IV registrations, including IVDs. Classes I–II use notification, outside this mechanism. | ANVISA may use an equivalent authority’s assessment to abbreviate its review. The Brazilian dossier remains required, and optimized review does not change queue order. | Local holder, applicable dossier and language requirements, Brazilian requirements, GMP certification where required, and queue position. | I–II: routine notification processing up to 30 days. III–IV: published legal analysis periods are by product type: 250 days equipment; 320 days materials; 365 days IVDs. No separate guaranteed optimized-route deadline verified. (IN nº 290, de 04/04/2024) |
Korea — MFDS/NIDS | No general foreign-certificate substitution in the ordinary product route; evidence reuse. I: notification; II: generally certification, with specified exceptions requiring approval; III–IV: approval. | Acceptable overseas reports can support the Korean assessment. Foreign approval itself does not establish an abbreviated foreign-certificate route. | Korean submission and assessment, licensed importer, applicable testing/clinical evidence and KGMP. | II certification: 5 days for the certification step, excluding preceding technical review. Approval cases, including III–IV: 65 days with technical-document review; 80 days with clinical-data review; 10 days where technical review is unnecessary. No quantified Class I target verified here. (Ministry of Food and Drug Safety) |
Japan — MHLW/PMDA | No general foreign-certificate substitution in the ordinary Japanese route. I: notification; II–III: certification where applicable standards exist, otherwise approval; IV: approval. | Foreign evidence can support the application; foreign approval does not replace the Japanese notification, certification or approval. | MAH/DMAH arrangements, applicable Japanese assessment, evidence requirements and QMS procedures. | Approval targets are by review category, not risk class: new devices 14 months, priority new 10; improved devices 10 with / 6 without clinical data; generic devices 4. These are PMDA approval-cohort performance targets, not individual guarantees. No universal notification/certification target verified. (Pharmaceuticals and Medical Devices Agency) |
Three consequences follow for these markets, and none of them are obvious at the time.
Timing is inherited. Under registration-only and partial reliance the base approval is a gate, not an accelerant: the dependent filing cannot start until the base certificate exists. Sequencing is therefore a base-approval decision. Top-tier markets queue behind whichever base you pick; a no-reliance market like Japan can run in parallel from day one.
Scope is inherited. Your registration abroad generally cannot be broader than the base it leans on. If your CE certificate covers three models and your FDA clearance five, the base you cite decides which two you cannot sell.
Validity is inherited. Foreign approval status requires continued monitoring. Safety-related restrictions can trigger local reporting, corrective action and regulatory reassessment, even where the local authorization remains legally independent. Administrative expiry and commercial withdrawal must be assessed separately against the applicable route and authorization conditions.
Which changes trigger a new submission where it is worked through in our decision framework for when a device change requires a new submission.
The test: pick the base whose change cadence you can absorb, not the one that clears fastest. A base that saves weeks in Riyadh and generates four change notifications a year has saved you nothing.
4 · How the device family is defined
You decide which SKUs, models, sizes and configurations travel together on one registration. Grouping rules differ by market, and a grouping accepted in one place may require separate applications in another. Canada’s statutory term is “system”, and the list also includes medical device family, medical device group, medical device group family, and test kit.
Singapore permits qualifying families of systems, whereas Brazil’s RDC 556/2021 framework for medical materials prohibits them. Keep that Brazilian scope qualification: orthopedic implants are excluded from RDC 556, and equipment grouping follows RDC 542/2021 rather than the same materials rules.
Group too narrowly and you can multiply application fees and the work of maintaining separate authorizations. Group too broadly and the authority may reject the grouping, requiring separate applications. A shared licence can also widen the consequences of a suspension, although an adverse finding does not automatically affect every family member.
Canada and Singapore permit qualifying additions through amendments or change notifications; Brazil also permits additions within eligible existing groupings. Changing the grouping after approval can mean an amendment, a change notification or a new application, depending on the market and whether the revised grouping still meets its rules.
The test: group by what changes together, not by what sells together. A family assembled from a price list is a liability.
5 · What the label carries
One label used everywhere, or a label per market. The trade is symmetrical: a global label does not automatically mean one artwork change becomes a change notification in every jurisdiction you sell in; a label per market means N artwork revisions and N change controls. Some administrative label changes require only internal change control; some local details can appear on a supplementary label or accompanying document.
A shared label can create shared implementation work, while market-specific information can sometimes be maintained through local overlabels or accompanying documents. Whether a label change requires regulatory filing depends on its content, the affected regulatory records and the market’s change rules.
The detail that catches people: if the importer or local representative address appears on the label, changing importer is an artwork change — and an artwork change is a regulatory change in some jurisdictions.
The test: decide language scope by the smallest unit of change, not by translation cost. Translation is a quote; change control is a permanent liability.
Renewal is a decision, not a task
Renewal cycles are market data and they move. What is durable is who owns the obligation.
Registrations expire on a date set years earlier by someone who has since changed roles, and the first signal is often a customs hold. Several markets also require, at renewal, evidence that the device is still marketed in the base jurisdiction — a certificate of free sale or equivalent — with its own lead time and its own owner. Under the higher reliance tiers this is the same dependency as at first filing, arriving again.
However, we must distinguish permission to market from actual commercial sales. An FSC commonly establishes lawful marketability; it does not necessarily prove the device is actively being sold.
Destination market | Foreign-market evidence required at renewal? | Source |
Bahrain — NHRA | Yes. Renewal requires an FSC or Certificate to Foreign Government from the country of origin or a reference country. Separately, the manufacturer must provide a list of countries where the device has been marketed. | Medical Devices Registration Guideline, version 9.1, September 2024, §10, unconditional requirements 2 and 4. Expired or amended supporting documents must also be updated. (nhra.bh) |
UAE — Emirates Drug Establishment | Yes. The published medical-device renewal checklist requires a certificate of free sale/registration issued by the competent authority in the country of origin, plus applicable conformity/marketing-authorization certificates. | EDE’s current service, Renewal of Marketing Authorization for a Medical Device, Required Documents. The checklist does not itself establish a universal requirement that the FSC be newly issued within a particular number of months. (EDE Portal) |
Brazil — ANVISA | Not as a general renewal requirement. The ordinary renewal list requires the imported device’s manufacturer authorization letter and a valid ANVISA GMP certificate. It does not repeat the initial-registration FSC requirement. | RDC 751/2022, Article 27, contrasted with Article 14(IV). Product-specific requirements may add documents. (RDC nº 751, de 15/09/2022) |
China — NMPA | Expressly not required for ordinary imported-device renewal. The renewal requirements state that proof of permission to market in the registrant’s or manufacturing jurisdiction need not be supplied. | NMPA Announcement 121/2021, Annex 6, effective 1 January 2022; the reproduced annex states the exemption explicitly. (beijing.gov.cn) |
Saudi Arabia — SFDA | Route-dependent; a universal renewal FSC requirement is not confirmed. Current reliance guidance requires valid recognized approval and illustrates supplying approval evidence in a renewal application. That supports a dependency for a renewal using that route, not a blanket FSC requirement for every MDMA renewal. | MDS-G030, version 1.0, 9 September 2026, eligibility criteria and application instructions. (www.sfda.gov.sa) |
For certificate procurement, using published service targets, can provide actual visibility into “anticipated” lead times:
Base jurisdiction / issuer | Certificate | Published issuance timing |
US — FDA | Certificate to Foreign Government or other applicable export certificate | 20 working days is the statutory fee-linked processing benchmark described by FDA—not an unconditional delivery guarantee. (FDA) |
UK — MHRA | Certificate of Free Sale | Aims for 10 working days from receipt; busy periods can take longer. (GOV.UK) |
Australia — TGA | Certificate of Free Sale / Export Certificate | Aims for 10 working days. Processing waits for payment; ARTG details must already be correct. (Therapeutic Goods Administration (TGA)) |
Singapore — HSA | FSC / Export Certificate | 14 working days. (Health Sciences Authority) |
Canada — Health Canada | Manufacturer’s Certificate to Export | Current GUI-0097 states there is no service standard. Do not use the 10-business-day figure from the older guidance. (Canada.ca) |
EU member state | FSC under MDR Article 60 | Issued by the relevant member state; Article 60 sets no EU-wide issuance deadline. Confirm the particular national issuer’s timeline. (eur-lex.europa.eu) |
Note: These periods exclude any additional notarization, apostille/legalization and translation. MHRA expressly describes a separate notarization/authentication process where required by the receiving country.
Three things need a named owner on the day the certificate is granted: the date renewal must be initiated, not just the expiry date; the documents it will require and who produces them; and the person notified if the first date passes without the second happening.
The framework
Decision | What happens if nobody decides | Cost to reverse | Lock it before |
Entity structure — legal manufacturer and in-country representative | The entities named in the first filing become the template for subsequent markets | Updates across affected authorizations, contracts and labels. Replacing a legal entity can require transfer, new certification or new registration; a name/address change may follow a simpler route | The first dossier in the first market |
Registration ownership — whose name is on the certificate | The local partner becomes the holder because they handled the filing | A holder-transfer procedure where available; otherwise a new application. Cooperation, fees and transition planning may be needed to avoid an interruption in supply | Contract signature with the local partner |
Base approval — which existing approval supports the chosen route | The team uses whichever approval is easiest to retrieve | Loss of eligibility for the intended reliance route, additional assessment or a revised filing strategy. The claimed scope must meet that route’s requirements | Portfolio sequencing, before dossier scoping |
Device family — what travels on one registration | The regulatory grouping follows the commercial catalogue | An amendment or change notification where the revised grouping remains eligible; a separate application where it does not. Some markets prohibit converting an approved single-product registration into a family | Dossier scoping |
Labeling scope — shared artwork, market-specific artwork or local supplementary labels | The first artwork release becomes the operating model | Artwork revisions, inventory transition and change assessment in each affected market. Notification or amendment depends on what changed and the local rules | Artwork release for the first market |
Renewal ownership — who monitors deadlines and obtains supporting evidence | Responsibility stays with an individual rather than a maintained process | Missed filing windows, possible lapse and a new application where late renewal is unavailable. Supply interruption or a customs hold may follow; required supporting certificates add their own dependencies | Certificate grant, with a named owner, backup and handover process |
What to do Monday
Open a spreadsheet. One row per registration — held and planned. Six columns matching the six rows above, plus a seventh: which reliance tier this market sits in, and which base certificate it depends on.
Fill it from records, not memory. In most portfolios of any age a meaningful share of cells comes back blank, and the blanks are the finding. A registration whose holder you cannot name from a document is one you may not control.
See what your portfolio looks like when everything is sellable — and audit-ready.
A 30-minute demo, on your products and your markets. No sandbox, no trial to configure — a working conversation with people who know regulatory.
See what your portfolio looks like when everything is sellable — and audit-ready.
A 30-minute demo, on your products and your markets. No sandbox, no trial to configure — a working conversation with people who know regulatory.
See what your portfolio looks like when everything is sellable — and audit-ready.
A 30-minute demo, on your products and your markets. No sandbox, no trial to configure — a working conversation with people who know regulatory.