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🌍 Global Acceptance of Foreign Medical Device Certificates

✅ 1. Australia (TGA)

Highly Accepting

  • Accepts certificates from: EU (MDR/IVDR), US FDA, Health Canada, Japan PMDA.

  • Leverages third-party reviews and uses comparable overseas regulators (CORs).

  • Can fast-track approval for Class II and III devices based on EU or FDA approvals.

  • Notes: Leverages foreign assessments heavily, reducing time-to-market.

 

✅ 2. Canada (Health Canada)

Accepting

  • Accepts: FDA, EU, Australia, Japan certifications.

  • Recognizes MDSAP (Medical Device Single Audit Program), which includes audits from multiple jurisdictions.

  • Notes: MDSAP participation is effectively mandatory, creating indirect acceptance of foreign audits.

 

✅ 3. Singapore (HSA)

Highly Accepting

  • Accepts: EU, US, Australia, Canada, Japan approvals.

  • Offers expedited routes via Priority Review or Full Evaluation Based on Reference Agency Approval.

  • Notes: Leverages foreign regulatory approvals extensively.

 

✅ 4. Malaysia (MDA)

Moderately Accepting

  • Accepts: EU CE Mark, FDA, TGA, Health Canada.

  • Uses Reference Agency Evaluation Routes to fast-track registrations.

  • Notes: Requires conformity to local classification but often piggybacks on EU or FDA data.

 

✅ 5. Saudi Arabia (SFDA)

Moderately Accepting

  • Accepts: EU, US, Australia, Canada certifications.

  • Has a GHTF-aligned fast-track route for preapproved devices.

  • Notes: Foreign evidence is required for registration but must still go through local submission.

 

✅ 6. United Arab Emirates (MoHAP)

Accepting

  • Accepts CE, FDA, TGA.

  • Fast-track pathways available for devices approved by reference countries.

  • Notes: Still requires local registration agent and Arabic labeling.

 

✅ 7. South Korea (MFDS)

Selective Acceptance

  • May leverage foreign clinical or safety data, especially from GHTF countries.

  • Still performs its own review for higher-class devices.

  • Notes: Does not fully waive review; more of a hybrid model.

 

✅ 8. Brazil (ANVISA)

Limited Acceptance

  • Accepts: Some reliance on foreign certifications (FDA, CE) for Class I and II.

  • Class III/IV devices often require ANVISA’s own review.

  • Notes: Slow timelines despite foreign certificates; highly bureaucratic.

 

✅ 9. China (NMPA)

Low Acceptance

  • Requires home country approval for all devices besides innovative products in another pathway.

  • May accept foreign clinical data if it meets China’s GCP standards.

  • Notes: Strong local requirements; language and testing hurdles common.

 

✅ 10. India (CDSCO)

Low Acceptance

  • Requires: Home country approval and often local testing.

  • Does not fully rely on foreign certificates.

  • Notes: Recent updates have increased regulatory stringency; registration process remains manual and slow.

 

Countries Where Home Country Approval Is NOT Required

These countries allow manufacturers to legally register devices even if they are not approved in their home country. Of course EU, US are on the top of the list, where else

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Malaysia

Does not require home country approval if clinical data and other technical documentation are complete.

UAE

Allows local submission without prior home market approval, subject to safety evidence.

Vietnam

Registration possible without home approval; approval based on dossier quality.

Indonesia

Some device categories can be registered without prior approval in home country.

Philippines

Class A and B devices can skip home approval if risk is low and documentation is robust.

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