Where Does Your CE Mark Actually Get You? The Global Reliance Map for Medical Device Manufacturers

Your CE Mark Is Worth More Than EU Market Access

CE marking under EU MDR (Regulation 2017/745) or EU IVDR (Regulation 2017/746) is one of the most recognized regulatory approvals globally. But the extent to which it helps you enter markets beyond the EU/EEA varies dramatically — from countries that will register your device based on CE certification alone, to countries where CE is noted but carries no regulatory weight.

This guide organizes 25+ countries by the mechanism through which they recognize or leverage your CE mark. Understanding these mechanisms is essential for building a regulatory market access strategy that maximizes the return on your CE marking investment.

The Four Mechanisms of CE Mark Recognition

Mechanism	What It Means	Regulatory Shortcut
A. Full Reliance	CE certification alone (or with minimal local administrative steps) is sufficient for market access. No full local technical review.	Significant — weeks to months instead of 6–12+ months
B. Abridged / Expedited Review	CE certification qualifies you for a shortened review track, but the local authority still conducts its own assessment.	Moderate — 30–50% shorter review timeline
C. Evidence-Only Acceptance	CE technical documentation is accepted as supporting evidence, but you must still complete a full local submission and review process.	Limited — reduces documentation preparation burden, not review time
D. Reference-Only / No Regulatory Weight	CE mark is considered as background information but carries no legal shortcut. Full local review required regardless.	None — regulatory benefit is informational only

---

Tier A: Full Reliance Pathway

These countries will register your device based primarily on CE certification, with minimal additional local steps.

A1. Switzerland

Attribute	Detail
Regulatory Authority	Swissmedic
CE Mechanism	Switzerland has transposed EU MDR/IVDR into national law (MEDEV/MepV). CE-marked devices are automatically accepted.
What CE Gets You	Full market access. No separate Swiss conformity assessment required for CE-marked devices.
Local Steps Required	Swiss Authorized Representative (CH REP) mandatory. Swissdamed registration by July 1, 2026 (transition until December 31, 2026).
Key Reference	Federal Act on Medical Devices (Medizinproduktegesetz, SR 812.213)

A2. Norway, Iceland, Liechtenstein (EEA/EFTA)

Attribute	Detail
Regulatory Authority	National health authorities (e.g., Norwegian Medicines Agency / Statens legemiddelverk)
CE Mechanism	As EEA/EFTA members, these countries are part of the EU's single market for medical devices. CE marking has the same legal force as in EU member states.
What CE Gets You	Full market access. No additional registration beyond EUDAMED requirements.
Local Steps Required	Same as any EU member state — EUDAMED registration, local importer requirements.
Key Reference	EEA Agreement, Annex II — Technical barriers to trade

A3. Turkey

Attribute	Detail
Regulatory Authority	Turkish Medicines and Medical Devices Agency (TITCK)
CE Mechanism	Turkey has a Customs Union with the EU and has transposed EU medical device directives into domestic law. CE-marked devices are accepted under the mutual recognition framework.
What CE Gets You	Full market access for CE-marked devices.
Local Steps Required	Product registration with TITCK, local authorized representative, Turkish labeling.
Key Reference	Turkey Medical Device Regulation, aligned with EU MDD/MDR framework

A4. Singapore (for certain classes)

Attribute	Detail
Regulatory Authority	Health Sciences Authority (HSA)
CE Mechanism	HSA's Full, Abridged, and Expedited review routes. CE-marked devices from recognized reference markets (EU, US, Australia, Japan, Canada) qualify for Expedited or Abridged routes depending on risk class.
What CE Gets You	For Class B/C devices with CE mark from EU Notified Body: Abridged route (shorter review than Full). Class A devices are exempt from product registration but require a Dealer's Licence.
Local Steps Required	HSA application, local registrant (Singapore-based), product labeling review.
Timeline Reduction	Full route: 6–12 months. Abridged with CE: 4–9 months. Expedited/IBR (Immediate Based on Reliance): as fast as 2–4 months for devices approved by 2+ reference agencies.
Key Reference	Health Sciences Authority — Guidance on Medical Device Registration

A5. Australia (for certain classes)

Attribute	Detail
Regulatory Authority	Therapeutic Goods Administration (TGA)
CE Mechanism	TGA permits use of CE certificates issued under MDR/IVDR to support device approval as part of its regulatory reliance strategy.
What CE Gets You	Eligible for abridged conformity assessment — fewer documents to submit, reduced depth of TGA evaluation, potential reduction in assessment fees.
Local Steps Required	Australian sponsor mandatory. TGA application still required. Australian Register of Therapeutic Goods (ARTG) inclusion.
Key Reference	Therapeutic Goods Act 1989, TGA regulatory reliance framework

A6. New Zealand

Attribute	Detail
Regulatory Authority	Medsafe (New Zealand Medicines and Medical Devices Safety Authority)
CE Mechanism	Mutual Recognition Agreement (MRA) between the EU and New Zealand covers conformity assessment. CE-marked medical devices benefit from this MRA.
What CE Gets You	Streamlined market access under the MRA framework.
Local Steps Required	Product notification to Medsafe, New Zealand sponsor.
Key Reference	EU-New Zealand Mutual Recognition Agreement on Conformity Assessment

A7. Israel

Attribute	Detail
Regulatory Authority	AMAR (Israeli Medical Device Division, Ministry of Health)
CE Mechanism	AMAR accepts CE marking as a basis for registration because the EU is listed as a recognized country under Schedule 1 of Israel's Medical Equipment Law (2012). Israel does not have its own classification system and relies on the classification from recognized countries.
What CE Gets You	Registration based on CE certification. AMAR review focuses on local requirements rather than full technical assessment.
Local Steps Required	Israeli Registration Holder (IRH), AMAR application, Hebrew/Arabic labeling for home-use devices, Standards Institution of Israel (SII) approval for electrical devices.
Key Reference	Israel Medical Equipment Law, 5772-2012; AMAR registration procedures

A8. Serbia

Attribute	Detail
Regulatory Authority	Medicines and Medical Devices Agency of Serbia (ALIMS)
CE Mechanism	Serbia recognizes foreign market authorization evidence. As part of its EU accession process, Serbia is aligning with EU standards. CE mark is accepted provided the product meets Serbian technical regulatory requirements.
What CE Gets You	Documentation accepted to support evaluation. No formal reliance pathway yet, but CE-marked devices receive favorable treatment during registration.
Local Steps Required	ALIMS registration prior to market placement. Serbian legal representative.
Key Reference	Serbian Law on Medical Devices; ALIMS registration guidelines

A9. Bosnia and Herzegovina

Attribute	Detail
Regulatory Authority	Agency for Medicines and Medical Devices of Bosnia and Herzegovina (ALMBiH)
CE Mechanism	Bosnia and Herzegovina accepts and considers overseas market authorization evidence, particularly from the EU, as part of its device registration process.
What CE Gets You	CE certificate streamlines the registration evaluation. Products with CE marking receive favorable treatment.
Local Steps Required	ALMBiH registration, local representative.

A10. Montenegro

Attribute	Detail
Regulatory Authority	Agency for Medicines and Medical Devices of Montenegro (CInM)
CE Mechanism	Montenegro accepts CE-marked devices and recognizes EU market authorization evidence. CE certificate supports the registration evaluation.
What CE Gets You	Streamlined registration process with CE documentation as the primary evidence.
Local Steps Required	CInM registration, local representative.

A11. North Macedonia

Attribute	Detail
Regulatory Authority	Agency for Medicines and Medical Devices (MALMED)
CE Mechanism	North Macedonia is currently reforming its medical device regulations to align with EU standards as part of its EU accession process. CE certificate is accepted and considered as part of the device registration process.
What CE Gets You	CE documentation supports the evaluation. No formal regulatory reliance framework, but favorable treatment.
Local Steps Required	MALMED registration, local representative.

A12. Albania

Attribute	Detail
Regulatory Authority	National Agency for Medicines and Medical Devices (AKBPM)
CE Mechanism	Albania accepts CE marking as part of its EU-harmonization process. CE certificate supports device registration.
What CE Gets You	Evidence of conformity. CE-marked devices receive favorable treatment during registration review.
Local Steps Required	AKBPM registration, local representative.

A13. Northern Ireland

Attribute	Detail
Regulatory Authority	MHRA (under Northern Ireland Protocol)
CE Mechanism	Under the Northern Ireland Protocol, CE marking continues to be recognized in Northern Ireland. CE-marked devices can be placed on the Northern Ireland market.
What CE Gets You	Full market access to Northern Ireland.
Local Steps Required	Northern Ireland-based importer or responsible person.

---

Tier B: Abridged / Expedited Review

These countries offer a shortened review track when you hold CE certification, but still conduct their own assessment.

B1. Saudi Arabia

Attribute	Detail
Regulatory Authority	Saudi Food and Drug Authority (SFDA)
CE Mechanism	SFDA regulations draw heavily from EU MDR. CE certificate is typically part of the supportive documentation for MDMA (Medical Device Marketing Authorization) applications.
What CE Gets You	Expedited review pathway — 35 working days for MDMA review. CE certificate serves as primary evidence of conformity. Without CE, the review may be longer and require additional documentation.
Local Steps Required	SFDA-licensed Authorized Representative (AR), MDMA application via GHAD system, Arabic/English labeling, UDI compliance with Saudi UDI framework.
Timeline	35 working days for MDMA.
Key Reference	SFDA MDS-REQ1 — Requirements for Medical Device Marketing Authorization

B2. United Kingdom (Great Britain)

Attribute	Detail
Regulatory Authority	MHRA
CE Mechanism	MHRA currently accepts CE-marked medical devices in Great Britain. CE recognition has been extended — currently accepted until at least June 2028 (or June 2030 depending on device). MHRA is considering indefinite acceptance of CE marks.
What CE Gets You	Market access to GB without UKCA marking. MHRA is also proposing an international reliance pathway for devices approved in Australia, Canada, and the USA.
Local Steps Required	UK Responsible Person (UKRP), UKCA marking (if not using CE recognition route), MHRA registration.
Key Reference	MHRA guidance on CE mark recognition; UK Medical Devices Regulations 2002 (as amended)

B3. Malaysia

Attribute	Detail
Regulatory Authority	Medical Device Authority (MDA)
CE Mechanism	MDA Circular Letter No. 1/2025 introduced a "verification" process for CE-marked devices. CE certification qualifies devices for streamlined conformity assessment.
What CE Gets You	Verification route — CE-marked devices can be registered more efficiently. Reduced documentation requirements compared to full assessment pathway.
Local Steps Required	MDA application, local authorized representative (Malaysian-licensed establishment), CSDT-format submission.
Timeline	Verification route: typically 3–6 months. Full route: 6–12 months.
Key Reference	MDA Circular Letter No. 1/2025; Medical Device Act 2012 (Act 737)

B4. Philippines

Attribute	Detail
Regulatory Authority	FDA Philippines — Center for Device Regulation, Radiation Health, and Research (CDRRHR)
CE Mechanism	Under ASEAN Medical Device Directive (AMDD) implementation (FDA Circular No. 2021-002), CE-marked devices may qualify for the ASEAN recognition pathway.
What CE Gets You	Potentially shortened review under ASEAN reliance framework. CE technical documentation supports the CSDT submission.
Local Steps Required	Philippine FDA registration, local authorized representative (LAR), CSDT-format dossier.
Key Reference	FDA Philippines Circular No. 2021-002; ASEAN Medical Device Directive

B5. United Arab Emirates

Attribute	Detail
Regulatory Authority	Emirates Drug Establishment (EDE) — replaced MOHAP effective January 2, 2025 under Federal Decree-Law No. 38/2024
CE Mechanism	EDE recognizes CE marking for medical devices. CE-certified devices may qualify for expedited registration.
What CE Gets You	Shorter review timeline for CE-marked devices. CE certificate accepted as primary conformity evidence.
Local Steps Required	UAE-based agent/representative, EDE registration, Arabic labeling.
Key Reference	Federal Decree-Law No. 38/2024; EDE medical device registration guidance

---

Tier C: Evidence-Only Acceptance

These countries accept CE technical documentation as supporting evidence, but you must still complete a full local submission and review process.

C1. Brazil (ANVISA)

Attribute	Detail
Regulatory Authority	Agência Nacional de Vigilância Sanitária (ANVISA)
CE Mechanism	CE certificate is accepted as supporting documentation under RDC 751/2022. ANVISA considers CE marking as evidence of conformity but conducts its own technical review.
What CE Gets You	Documentation efficiency — you can reference your CE technical file and clinical evaluation. However, ANVISA still performs an independent review, especially for Class III and IV devices.
Local Steps Required	Brazil Registration Holder (BRH), ANVISA registration, BGMP certification for Class III/IV, possible INMETRO certification, Portuguese labeling.
Key Reference	ANVISA RDC 751/2022; RDC 830/2023 (IVDs)

C2. Colombia (INVIMA)

Attribute	Detail
Regulatory Authority	Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
CE Mechanism	INVIMA accepts CE certificate and technical documentation as supporting evidence. A Certificate of Free Sale or Certificate to Foreign Government from the country of origin is required. CE mark demonstrates prior regulatory approval.
What CE Gets You	Supports the registration application. INVIMA may grant "uncontrolled" (automatic) approval for Class I/IIa devices with CE marking. Class IIb/III devices still undergo INVIMA review.
Local Steps Required	Colombian legal representative, INVIMA registration, Spanish labeling, CTD format submission.
Key Reference	INVIMA Decree 4725/2005; Colombian medical device regulations

C3. Chile

Attribute	Detail
Regulatory Authority	Instituto de Salud Pública (ISP)
CE Mechanism	ISP accepts CE certification as supporting evidence for device registration. CE technical documentation supports the application.
What CE Gets You	Evidence of prior regulatory approval. May support expedited processing.
Local Steps Required	ISP registration, Chilean legal representative. Registration is indefinite once obtained (no renewal).
Key Reference	Chilean medical device regulations

C4. Egypt

Attribute	Detail
Regulatory Authority	Egyptian Drug Authority (EDA)
CE Mechanism	EDA references EU MDR classification and accepts CE certificates as part of the registration dossier. CE certificate is listed as a key document in the registration application.
What CE Gets You	Evidence of conformity. EDA classification generally references EU MDR risk classes. CE technical file supports the submission.
Local Steps Required	Egyptian Registration Holder (ERH), EDA registration (4–9 months), Arabic/English labeling.
Key Reference	EDA medical device registration guidance

C5. Peru

Attribute	Detail
Regulatory Authority	Dirección General de Insumos, Drogas y Medicamentos (DIGEMID)
CE Mechanism	DIGEMID accepts CE certificate as supporting evidence for device registration.
What CE Gets You	Evidence of prior regulatory approval. Supports the registration application.
Local Steps Required	DIGEMID registration, Peruvian legal representative, 5-year registration validity.
Key Reference	Peruvian medical device regulations

C6. Thailand

Attribute	Detail
Regulatory Authority	Thai Food and Drug Administration (Thai FDA)
CE Mechanism	Thai FDA accepts CE technical documentation under the CSDT format. CE certificate supports the application for Class 2–4 devices.
What CE Gets You	Documentation reuse — your CE technical file, clinical evaluation, and risk management file can be adapted for the CSDT submission.
Local Steps Required	Thai FDA registration, local authorized representative, establishment license, CSDT format submission.
Key Reference	Thai Medical Device Act B.E. 2551 (2008); ASEAN CSDT guidelines

C7. Indonesia

Attribute	Detail
Regulatory Authority	Ministry of Health (Kemenkes) / BPOM
CE Mechanism	Indonesia conducts its own review regardless of CE/FDA status. CE documentation is accepted as supporting evidence but does not replace local requirements.
What CE Gets You	Documentation reuse for the AKD (Alat Kesehatan — medical device) registration. CE technical file can be adapted, but Indonesia-specific requirements must be addressed.
Local Steps Required	AKD registration, local distributor with CDAKB compliance, Indonesian labeling, possible halal certification.
Key Reference	Indonesian Ministry of Health medical device regulations

C8. Vietnam

Attribute	Detail
Regulatory Authority	Ministry of Health (MOH) / Department of Medical Equipment and Construction (DMEC)
CE Mechanism	Vietnam broadly recognizes reference agency approvals. CE certification supports the registration application, particularly for Class B/C/D devices.
What CE Gets You	Class A/B: Registration in as fast as 7 days with reference approval evidence. Class C/D: Streamlined review with CE supporting documentation.
Local Steps Required	Vietnamese registration holder, MOH application, Vietnamese labeling.
Key Reference	Vietnam Law on Medical Devices; MOH Circular 08/2023/TT-BYT

---

Tier D: Reference-Only / No Regulatory Weight

These countries are aware of CE marking but it provides no formal regulatory shortcut. Full local review is required regardless.

D1. China (NMPA)

Attribute	Detail
Regulatory Authority	National Medical Products Administration (NMPA)
CE Status	CE certification has no formal regulatory weight in China. NMPA requires a full domestic registration process for Class II and III devices.
What This Means	You cannot leverage your CE certificate to skip or shorten NMPA registration. Full NMPA type testing (at a Chinese laboratory), clinical data (possibly Chinese clinical trials), and NMPA technical review are required.
Key Reference	China Order No. 739 — Regulations on the Supervision and Administration of Medical Devices

D2. Russia (Roszdravnadzor)

Attribute	Detail
Regulatory Authority	Federal Service for Surveillance in Healthcare (Roszdravnadzor)
CE Status	CE marking is considered but carries no formal regulatory shortcut. Russia requires its own registration certificate (RU) for all medical devices.
What This Means	Full Russian registration process required, including possible local testing, Russian-language documentation, and Roszdravnadzor review.
Key Reference	Federal Law No. 323-FZ on Fundamentals of Protecting the Health of Citizens

D3. India (CDSCO)

Attribute	Detail
Regulatory Authority	Central Drugs Standard Control Organization (CDSCO)
CE Status	CE certificate is referenced but does not provide a formal regulatory shortcut. CDSCO requires full import license (MD-14/MD-15) process.
What This Means	Full CDSCO application, Indian Authorized Agent, SUGAM portal submission. BIS certification required for electronic medical devices.
Key Reference	Medical Devices Rules (MDR) 2017

D4. Japan (PMDA)

Attribute	Detail
Regulatory Authority	Pharmaceuticals and Medical Devices Agency (PMDA)
CE Status	CE marking has no formal regulatory weight. Japan has its own comprehensive regulatory framework (Todokede/Ninsho/Shonin pathways).
What This Means	Full PMDA registration required: MHLW Ordinance No. 169 QMS compliance, Designated Marketing Authorization Holder (DMAH/MAH), Foreign Manufacturer Registration (FMR). All documents in Japanese.
Key Reference	Pharmaceuticals and Medical Devices Act (PMD Act)

D5. South Korea (MFDS)

Attribute	Detail
Regulatory Authority	Ministry of Food and Drug Safety (MFDS)
CE Status	CE marking is referenced but does not provide a formal shortcut. MFDS requires Korean GMP (KGMP) certification, which is separate from ISO 13485.
What This Means	Full MFDS registration: notification/certification/approval pathway, KGMP audit, Korea License Holder (KLH).
Key Reference	Medical Devices Act (South Korea)

D6. Canada (Health Canada)

Attribute	Detail
Regulatory Authority	Health Canada
CE Status	Health Canada does not formally recognize CE marking. Canada has its own Medical Device Regulations (MDR) under the Food and Drugs Act.
What This Means	Full Health Canada application, MDSAP certification, Medical Device License (MDL) application.
Key Reference	Canada Food and Drugs Act; Medical Device Regulations (SOR/98-282)

D7. Mexico (COFEPRIS) — Fast-Track Available with CE

Attribute	Detail
Regulatory Authority	Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
CE Status	COFEPRIS offers a 30-day fast-track (aprobación automática) for devices with FDA or CE approval under Article 376 of the Mexican General Health Law. This is effectively a Tier B (abridged review) pathway for CE-marked devices. Mexico is listed in Tier D because full local registration is still required — the fast-track shortens but does not eliminate the COFEPRIS review.
What This Means	With CE certificate, you may qualify for the fast-track pathway (approximately 30 working days). Without it, standard pathway takes 3–6 months.
Key Reference	COFEPRIS medical device registration guidelines; Article 376 compliance requirements

D8. Argentina (ANMAT)

Attribute	Detail
Regulatory Authority	Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)
CE Status	CE certificate is considered as reference information. Full ANMAT registration is required.
What This Means	Full registration process: 6–12 months, Argentine legal representative.
Key Reference	ANMAT Disposición 3567/2011 and subsequent updates

---

Strategic Summary: The CE Mark Value Matrix

Country	Tier	CE Benefit	Additional Local Steps	Effective Time Savings
Switzerland	A	Full access	CH REP, Swissdamed	Complete — no additional conformity assessment
Norway/Iceland/Liechtenstein	A	Full access	EUDAMED registration	Complete — part of single market
Turkey	A	Full access	TITCK registration, local rep	Complete — mutual recognition
Singapore	A	Abridged/IBR review	HSA application, local registrant	25–50% time savings (abridged); up to 60% (IBR with 2+ ref approvals)
Australia	A	Abridged assessment	TGA application, Australian sponsor	30–50% time savings
New Zealand	A	Streamlined under MRA	Medsafe notification, NZ sponsor	Significant under MRA
Israel	A	Registration basis	AMAR application, local importer	Significant — MRA-based
Serbia	A/B	CE accepted, favorable treatment	ALIMS registration, local rep	Documentation efficiency
Bosnia and Herzegovina	A/B	CE recognized, streamlined	ALMBiH registration, local rep	Documentation efficiency
Montenegro	A/B	CE recognized, streamlined	CInM registration, local rep	Documentation efficiency
North Macedonia	A/B	CE considered during EU alignment	MALMED registration, local rep	Documentation efficiency
Albania	A/B	CE accepted during EU alignment	AKBPM registration, local rep	Documentation efficiency
Saudi Arabia	B	Expedited MDMA review	SFDA AR, GHAD application	35-day review vs. longer without CE
United Kingdom (GB)	B	CE recognition (until 2028/2030)	UKRP, MHRA registration	Avoids UKCA process
Malaysia	B	Verification route	MDA application, local rep	3–6 months vs. 6–12 months
UAE	B	Expedited registration	EDE registration, local agent	Shorter timeline with CE
Philippines	B	ASEAN recognition pathway	FDA registration, local rep	Shortened under AMDD
Brazil	C	Supporting evidence	BRH, ANVISA review, BGMP	Documentation efficiency only
Colombia	C	Supporting evidence	INVIMA registration, local rep	May enable automatic approval for low-risk
Egypt	C	Supporting evidence	ERH, EDA registration	Documentation efficiency
Thailand	C	Documentation reuse	Thai FDA, CSDT format	Documentation efficiency
Indonesia	C	Documentation reuse	AKD registration, local distributor	Documentation efficiency
Vietnam	C	Reference evidence	MOH registration, local holder	7-day fast-track for Class A/B
China	D	No regulatory weight	Full NMPA process	None
Russia	D	No regulatory weight	Full Roszdravnadzor process	None
India	D	No regulatory weight	Full CDSCO process	None
Japan	D	No regulatory weight	Full PMDA process	None
South Korea	D	No regulatory weight	Full MFDS process	None
Canada	D	No regulatory weight	Full Health Canada process	None
Mexico	B/D	Fast-track available	COFEPRIS 30-day track if CE/FDA	30 days vs. 3–6 months

How to Use This Map in Your Regulatory Strategy

1. Start with Tier A countries. If you hold CE marking, you should immediately register in Switzerland (Swissdamed), Turkey (TITCK), Singapore (HSA), Australia (TGA), New Zealand (Medsafe), and Israel (AMAR). These markets offer the highest return on your CE investment with the lowest incremental regulatory cost.

2. Add Tier B countries in your next wave. Saudi Arabia, UK, Malaysia, and the Philippines offer meaningful time savings. Factor the local representative appointment and application preparation into your market access timeline.

3. Use Tier C for portfolio-level expansion. For markets like Brazil, Colombia, Egypt, Thailand, and Vietnam, your CE technical documentation reduces preparation time but does not shorten the regulatory review. Plan these as medium-term market entries.

4. Treat Tier D as standalone registrations. China, Japan, India, and South Korea require fully independent registration strategies. Do not budget time savings from CE marking into your plans for these markets.

5. Combine CE with FDA approval for maximum leverage. Holding both CE mark and FDA 510(k) or PMA approval unlocks additional pathways — COFEPRIS fast-track in Mexico, enhanced credibility in Tier C markets, and dual-reference advantages across ASEAN and LATAM.

Key References

• EU MDR Regulation (EU) 2017/745 — Annex VIII classification rules
• EU IVDR Regulation (EU) 2017/746
• RQM+ — "Where can your CE mark take you next?" (2026)
• European Commission — List of Mutual Recognition Agreements
• HSA Singapore — Guidance on Medical Device Registration
• TGA Australia — Regulatory reliance framework
• SFDA Saudi Arabia — MDS-REQ1
• MHRA UK — CE mark recognition guidance
• MDA Malaysia — Circular Letter No. 1/2025
• ANVISA Brazil — RDC 751/2022
• EDA Egypt — Medical device registration guidance
• Swissmedic — Swissdamed registration obligations 2026