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Certifications

Compare FDA 510(k), CE MDR, MFDS, PMDA, NMPA, MDSAP, and other medical device certifications. Review timelines, costs, prerequisites, and renewal requirements in one place.

Track certification requirements across global markets58

Difficulty

ANMAT Medical Device Registration (Argentina)

Argentina

MediumANMAT

Argentine National Administration of Drugs, Food and Medical Devices (ANMAT) registration under Disposition 2318/2002. Risk-based classification (Class I-IV). Product registration (Registro de Producto Medico) required for all devices. Local authorized representative with ANMAT establishment licence mandatory.

Duration

6-12 months

Cost

$5,000 - $20,000

Renewal

5 years

Requirements

  • Argentine authorized representative with ANMAT establishment licence
  • Technical documentation in Spanish with legalized translations
  • ISO 13485 QMS certificate and GMP compliance evidence
  • Product performance and safety test reports
  • Clinical evaluation report for Class III/IV devices
Local Rep RequiredOfficial Site

ANVISA (Brazil)

Brazil

MediumANVISA

Brazilian Health Regulatory Agency registration. GMP certification (BGMP) required plus product registration based on risk classification.

Duration

12-24 months

Cost

BRL 30,000 - BRL 200,000

Requirements

  • Brazilian GMP (BGMP) certification
  • Brazilian Registration Holder (BRH)
  • Portuguese language documentation
  • INMETRO testing (if applicable)
Official Site

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ANVISA Medical Device Registration (Brazil)

Brazil (expanded)

HighANVISA

Brazilian Health Regulatory Agency (ANVISA) medical device registration under RDC 751/2022. Four-class risk system (I-IV). Brazilian GMP (BGMP) on-site inspection mandatory for Class II-IV manufacturers. Full Portuguese-language documentation in STED format required. Registration valid for 10 years.

Duration

12-24 months

Cost

$15,000 - $50,000

Renewal

5 years

Requirements

  • Brazilian Registration Holder (BRH) with ANVISA operating licence
  • Brazilian GMP (BGMP) certification via on-site factory inspection
  • Full technical dossier in Portuguese (STED format)
  • Clinical evaluation report for Class III/IV devices
  • Product-specific testing at ANVISA-recognized laboratories
Local Rep RequiredOfficial Site

Related Market Guides

ANVISA RDC Registration

Brazil

HighANVISA RDC

ANVISA Resolucao da Diretoria Colegiada (RDC) registration for medical devices under RDC 751/2022. Four-class risk system (I-IV). Class III/IV require pre-market approval with clinical evidence. Brazilian GMP (BGMP) on-site inspection mandatory for Class II-IV. Valid for 10 years.

Duration

12-30 months

Cost

BRL 50,000 - BRL 350,000 (~$10,000 - $70,000)

Requirements

  • Brazilian Registration Holder (BRH) with ANVISA operating licence
  • Brazilian GMP (BGMP) certification via on-site inspection
  • Full technical dossier in Portuguese (STED format)
  • Clinical evaluation report for Class III/IV devices
Official Site

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ASEAN AMDD/CSDT

ASEAN (10 countries)

MediumAMDD/CSDT

Common Submission Dossier Template (CSDT) under the ASEAN Medical Device Directive. Provides a harmonized dossier format accepted by all 10 ASEAN member states for product registration. Reduces duplication of effort when registering across multiple ASEAN markets simultaneously.

Duration

3-12 months (per country)

Cost

$5,000 - $35,000 per country

Requirements

  • CSDT dossier preparation (5 sections: administrative, QMS, design, labeling, clinical)
  • In-country Authorized Representative per target market
  • ISO 13485 QMS certificate
  • Product classification per ASEAN risk-based system (Class A-D)
Official Site

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ASEAN Medical Device Directive

ASEAN (10 countries)

MediumAMDD

Harmonized framework for 10 ASEAN member states. Four-class system (A-D). Each country requires separate registration, but the AMDD aligns technical requirements. Key markets: Singapore (HSA), Thailand (Thai FDA), Indonesia (BPOM), Malaysia (MDA).

Duration

3-12 months (per country)

Cost

$3,000 - $30,000 per country

Requirements

  • In-country Authorized Representative per market
  • ISO 13485 QMS certificate (mandatory)
  • ASEAN Common Submission Dossier Template (CSDT)
  • Product testing and labeling per national requirements
Official Site

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Featured Certifications

FDA 510(k) / PMA

USA

US FDA premarket notification for Class II devices (510k) or premarket approval for Class III (PMA). Required for all medical devices sold in the US market.

medium6-12 months (510k) / 1-3 years (PMA)

CE MDR (EU 2017/745)

EU (27 countries)

EU Medical Device Regulation replacing MDD. Mandatory CE marking for all medical devices in the European market with stricter clinical evidence requirements.

medium12-18 months

MDSAP

USA, Canada, Australia, Brazil, Japan

Single audit program recognized by 5 regulatory authorities. One audit covers multiple market access requirements simultaneously.

medium6-12 months

PMDA (Japan)

Japan

Japanese Pharmaceuticals and Medical Devices Agency approval. Shonin (approval) required for Class III/IV, Todokede (notification) for Class I/II.

high12-24 months

NMPA (China)

China

China National Medical Products Administration registration. Three-tier classification system with varying registration requirements.

high12-36 months

TGA (Australia)

Australia

Therapeutic Goods Administration inclusion in ARTG (Australian Register of Therapeutic Goods). Risk-based classification aligned with EU system.

medium3-12 months

Explore all 58 certifications →

Frequently Asked Questions

Which certification should I pursue first for medical device export?

It depends on your target market priority. FDA 510(k) and CE MDR are the most common starting points, but MDSAP can cover multiple markets simultaneously. Use the comparison view to evaluate timelines and costs.

How do I compare certification costs across countries?

The certifications page shows estimated costs, timelines, prerequisites, and renewal requirements side by side, so you can evaluate which markets offer the best return on regulatory investment.

Do I need a local representative for every certification?

Many markets require an Authorized Representative or local agent. The certification details include this requirement and link to the consultants section for finding qualified partners.

Map the certification path before you choose a target market

Regulatory feasibility shapes every downstream decision in medical device export. This page turns certification research into a comparable workflow by showing approval pathways, timelines, costs, and key requirements across major markets.

Use it to identify the fastest entry sequence, decide when you need local representatives or consultants, and connect each certification path to country-level market-entry guides.

What This Page Helps You Do

  • Compare approval pathways such as FDA 510(k), CE MDR, MFDS, PMDA, and NMPA.
  • Review cost, timeline, renewal, and prerequisite differences side by side.
  • Connect certification work to consultants, country guides, and regulatory alerts.