European Union
3 certifications
Certifications
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.
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Certification categories
Every certification in the directory belongs to one jurisdiction or standards family, so you can start from the market you are entering.
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Each entry carries the typical timeline range recorded in its GHMAP certification profile.
CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
Typical timeline
6–18 months
FDA 510(k) / PMA
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
Typical timeline
3–36 months
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
Typical timeline
6–12 months
UKCA
The UK's post-Brexit conformity mark for the Great Britain market, overseen by the MHRA.
Typical timeline
6–18 months
Health Canada MDL
Canada's medical device licensing system, built on ISO 13485 and MDSAP certification.
Typical timeline
2–12 months
GMP
The manufacturing quality framework underlying most device and pharmaceutical regulatory approvals worldwide.
Typical timeline
6–18 months
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Each entry carries the source status it was last reviewed under, and the date that review was recorded.
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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 intelFrance
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Market intelUnited States
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Important notice
Certification overviews on this page are general educational summaries, not jurisdiction-specific regulatory or legal conclusions. Timelines and costs are typical ranges that vary by device classification, target country, and applicant. Professional review is required before relying on any of this content for a business decision.
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