Find your certification path — before you commit budget to it
CE Marking, FDA registration, ISO 13485, UKCA, and country-specific approvals — structured with requirements, typical timelines, and estimated costs, so you know what you're actually signing up for.
13 certifications
European Union
CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
European Union
EU MDR
The EU regulation that defines medical device requirements — CE Marking is the certification mark it produces once satisfied.
European Union
IVDR
The EU regulation governing in vitro diagnostic devices — the IVD counterpart to the MDR.
United States
FDA 510(k) / PMA
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
International Standard
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
International Standard
ISO 9001
The general-purpose international quality management standard, often a stepping stone toward ISO 13485.
United Kingdom
UKCA
The UK's post-Brexit conformity mark for the Great Britain market, overseen by the MHRA.
Canada
Health Canada MDL
Canada's medical device licensing system, built on ISO 13485 and MDSAP certification.
Saudi Arabia
SFDA MDMA
Saudi Arabia's medical device authorization system, which relies substantially on prior CE or FDA approval.
Brazil
ANVISA
Brazil's medical device registration system, requiring a local Brazilian Registration Holder.
China
NMPA
China's medical device registration system, among the most demanding globally for higher-risk devices.
General / Export Documentation
Free Sale Certificate
Export documentation confirming a product is legally sold in its country of origin — often required by importing countries.
Manufacturing Quality
GMP
The manufacturing quality framework underlying most device and pharmaceutical regulatory approvals worldwide.
Browse by category
Certification categories
Most requested
Popular certifications
CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
6–18 months
FDA 510(k) / PMA
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
3–36 months
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
6–12 months
UKCA
The UK's post-Brexit conformity mark for the Great Britain market, overseen by the MHRA.
6–18 months
Health Canada MDL
Canada's medical device licensing system, built on ISO 13485 and MDSAP certification.
2–12 months
GMP
The manufacturing quality framework underlying most device and pharmaceutical regulatory approvals worldwide.
6–18 months
Freshness
Recently updated
CE Marking (Medical Devices)
European Union
Jul 1, 2026
ISO 13485 — Medical Devices Quality Management
International Standard
Jun 30, 2026
FDA Registration & Clearance
United States
Jun 25, 2026
EU MDR (Regulation 2017/745)
European Union
Jun 18, 2026
UKCA Marking
United Kingdom
Jun 10, 2026
By market
Country-specific certifications
Every certification below is cross-linked to its country's full GHMAP Country Intelligence profile — regulatory landscape, market size, and distributor context in one place.
🇩🇪 Germany
Market Intel →🇫🇷 France
Market Intel →🇮🇹 Italy
Market Intel →🇺🇸 United States
Market Intel →🇬🇧 United Kingdom
Market Intel →🇨🇦 Canada
Market Intel →🇸🇦 Saudi Arabia
Market Intel →🇧🇷 Brazil
Market Intel →🇨🇳 China
Market Intel →Go deeper
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Regulatory landscape, market size, and distributor context for 35 countries.
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Resources & FAQ
Explainer videos and answers to common market-access questions.
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Glossary
Plain-language definitions of market-access, regulatory, and reimbursement terms.
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