Global Medical Device Market Access Beyond the US and EU: Canada, UK, Japan, China, India, Brazil

Most medical device teams plan their first two markets well: the United States and the EU. The questions get harder after that. Which country should come third? Can you reuse your FDA or CE evidence? Do you need a local representative, a local test, or a local clinical study? This guide compares seven of the most requested markets beyond the US and EU (Canada, the United Kingdom, Australia, Japan, China, India and Brazil), shows where one quality system audit can open several doors, and gives a simple method for choosing the order in which to enter them.

Why a global plan matters before the first submission

Every extra market adds requirements that are cheaper to meet at the start than to retrofit later: labelling in other languages, a quality system audit that covers more than one regulator, a technical file organised so that it can be reused, and a clinical evidence plan that other regulators will accept. A team that designs its US and EU regulatory strategy with two or three further markets in mind usually saves months later.

The seven markets at a glance

This table is a planning aid, not a substitute for the regulator’s own rules. Details change, so confirm them before you commit budget.

Market	Regulator	Local presence needed	Quality system evidence	How much US or EU evidence can you reuse?
Canada	Health Canada	Manufacturer holds the licence; importers and distributors need an establishment licence	MDSAP certificate for Class II, III and IV	High: dossier follows familiar summary and evidence structure
United Kingdom	MHRA	UK Responsible Person for non-UK manufacturers	UKCA route: UK Approved Body; CE-marked devices recognised on the GB market	High, and rising as recognition and reliance rules are settled
Australia	TGA	Australian sponsor	Conformity assessment evidence, which can include EU notified body certificates or MDSAP, depending on device	High for many devices
Japan	MHLW and PMDA	Marketing Authorization Holder in Japan; registered foreign manufacturer	Japanese QMS Ordinance; MDSAP report can support the assessment	Medium: Japanese-language dossier and sometimes local data
China	NMPA	China agent (domestic responsible person)	Quality system documents and possible inspection	Low to medium: local type testing and clinical evaluation expected
India	CDSCO	Indian authorised agent holding an import licence (Form MD-15)	ISO 13485-based quality system	Medium to high: approvals in reference countries can reduce local clinical requirements
Brazil	ANVISA	Brazil Registration Holder	Brazilian GMP certificate for Class III and IV	Medium: documentation aligns with IMDRF table of contents, but certificates and local rules apply

MDSAP: one audit, several regulators

The Medical Device Single Audit Program lets an authorised auditing organisation audit your quality system once against ISO 13485 plus the requirements of the participating regulators. The five regulatory authorities that make up the program are the US FDA, Health Canada, Australia’s TGA, Brazil’s ANVISA and Japan’s MHLW and PMDA. Other regulators take part as official observers or affiliate members, and the UK MHRA is an official observer.

How each regulator uses the result differs, and that difference matters for planning:

• Canada requires an MDSAP certificate for Class II, III and IV licence applications. A standalone ISO 13485 certificate is not enough.
• Australia, Brazil, Japan and the US use MDSAP audit reports to support their own decisions, but they do not all make a certificate mandatory in the same way.
• Other markets may accept or lean on MDSAP outcomes without being program members.

If Canada is on your list, MDSAP is effectively mandatory, and since it also reduces audit load elsewhere, many manufacturers adopt it early. Our guide to ISO 13485 and MDSAP audit readiness covers how to prepare.

Market by market: what to expect

Canada

Canada is often the easiest next step for a company with a strong quality system. Devices are classified I to IV, Class II to IV need a medical device licence, and the quality system evidence is the MDSAP certificate. Read the full walk-through in our Health Canada licensing guide.

United Kingdom

Great Britain has its own regime after Brexit. The key planning facts for 2026 are that CE-marked devices continue to be accepted, the government confirmed in October 2026 that it intends to recognise EU MDR and IVDR devices indefinitely, and the UKCA route remains available. Registration with the MHRA and a UK Responsible Person are still part of the picture. See the UK medical device regulation guide.

Australia

Devices enter the market by inclusion in the Australian Register of Therapeutic Goods (ARTG), applied for by an Australian sponsor. The TGA classifies devices as Class I, IIa, IIb, III and active implantable, and it can use conformity assessment evidence from other recognised systems, which is why Australia is often grouped with Canada as a reliance-friendly market.

Japan

Japan is a high-value but procedure-heavy market. A Marketing Authorization Holder in Japan takes legal responsibility, the foreign manufacturing site is registered, and the route depends on class: notification for the lowest risk, certification by a registered certification body for some designated devices, and approval with PMDA review for others. Dossiers are in Japanese, and the Japanese QMS Ordinance applies, with MDSAP reports able to support the quality system assessment.

China

China is the largest market on this list and the longest project. Imported Class II and III devices need registration, a China agent, type testing against product technical requirements, and clinical evaluation. Plan it as a multi-year programme. Our NMPA registration guide explains the steps.

India

Under the Medical Devices Rules 2017, all devices are now regulated, with licences from the state or central authority for manufacture and an import licence for foreign products. See the India CDSCO guide.

Brazil

ANVISA regulates under RDC 751/2022 with four classes. Class I and II go through notification, while Class III and IV need full registration and a Brazilian GMP certificate, usually after an ANVISA inspection. A Brazil Registration Holder is required in every case. Devices with electrical safety implications can also need separate certification, so check the current list early.

How to choose the order of entry

1. Start from the commercial case. Rank markets by reachable revenue, reimbursement or tender access, and distributor interest, not by how easy the paperwork looks.
2. Score reuse. For each market, estimate how much of your existing technical file, test reports and clinical data you can reuse. High reuse means lower cost and shorter time.
3. Find the long-lead items. Local testing (China), local representatives (almost everywhere), a GMP inspection (Brazil) and translated dossiers (Japan, China) all start on the critical path. Begin them early.
4. Look for shared audits. If three target markets accept MDSAP evidence, one audit programme can serve all three.
5. Sequence in waves. A common pattern is reuse-friendly markets first (Canada, UK, Australia), then markets with moderate local requirements (India, Brazil, Japan), and the long-lead market (China) started in parallel if the business case supports it.

Build one global technical file

The cheapest way to support many markets is to build one core dossier and add country annexes. Practical steps:

• Organise the technical file around a recognised table of contents, so it can be mapped to each regulator’s template. Several regulators in this guide accept or build on the IMDRF structure.
• Keep risk management and design control records complete and traceable, because every regulator asks for them in some form.
• Plan clinical evidence once, with a view to which regulators will accept foreign data, and note where local data may be needed.
• Control labelling centrally: languages, symbols, UDI and local identifiers are easier to manage from one controlled source.
• Define post-market processes that can meet the shortest reporting timeline among your markets, then apply it everywhere.

Common mistakes

• Assuming an FDA clearance or CE certificate is accepted automatically. In most markets it supports the application, but it does not replace it.
• Appointing a local representative or distributor without checking what legal responsibility and which documents they will hold.
• Buying a standalone ISO 13485 certificate when the target market needs an MDSAP certificate.
• Ignoring translation and local labelling until the end of the project.
• Letting registrations lapse: many markets require renewals, annual fees or change notifications.
• Choosing markets by the length of the checklist rather than the business case.

Frequently asked questions

Which market should I enter after the US and EU?

There is no single answer, but Canada, the UK and Australia are common first choices because existing evidence can usually be reused. The right order depends on revenue potential, your quality system, and which local partners you already have.

Do I need MDSAP to sell in all of these markets?

No. Canada requires an MDSAP certificate for Class II, III and IV devices. The other program regulators use MDSAP reports to support their own processes, and the remaining markets in this guide have their own requirements.

Can I use my FDA 510(k) or CE certificate as proof of safety?

It is usually valuable supporting evidence, and in some markets it shortens review or removes local clinical requirements. It rarely replaces a local application, local labelling or local representation.

Is the RAC (Devices) exam relevant to these markets?

Yes. The RAC (Devices) credential expects broad knowledge of regulatory systems beyond FDA and EU MDR, and AptSkill’s Master Handbook covers regulators such as Health Canada, the MHRA, PMDA, NMPA, TGA, CDSCO and ANVISA alongside the US and EU.

This article is a general overview for training purposes. Regulatory requirements, fees and timelines change frequently, and the facts above reflect November 2026. Confirm current rules with each regulator and your regulatory advisers before making decisions.

Related reading

• Health Canada medical device licensing: MDL, MDEL and the MDSAP rule.
• UK medical device regulation: UKCA, CE recognition and MHRA registration.
• India CDSCO registration: licences, forms and the authorised agent.
• China NMPA registration: agent, type testing and clinical evaluation.
• Device classification (FDA and EU MDR): the starting point for every pathway decision.
• RAC (Devices) study material: global regulatory systems alongside FDA and EU MDR.

Talk to the AptSkill team

Planning your next markets, or preparing for a role that covers global regulatory affairs? Send us your device type, target countries and goal.