Global Medical Device Regulatory Acceptance of quality management system

We remind always manufacturer by international registration having valid ISO 13485 certificate. It is essential in most countries at least at initial registration.

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📋 Study our article with notes on:

• Acceptance of foreign regulatory certificates

• Requirement for ISO 13485 Quality Management System certification

• Use and acceptance of MDSAP

 

✅ 1. Australia (TGA)

• Foreign Certificates: Accepted (EU MDR, FDA, Canada, Japan)

• ISO 13485: ✅ Required

• MDSAP: ✅ Accepted — may waive QMS audit

• QM Note: Strong acceptance of international QMS certification

 

✅ 2. Canada (Health Canada)

• Foreign Certificates: Accepted

• ISO 13485: ❌ Not accepted alone

• MDSAP: ✅ Mandatory

• QM Note: Only MDSAP is accepted for QMS

 

✅ 3. Singapore (HSA)

• Foreign Certificates: Accepted

• ISO 13485: ✅ Required

• MDSAP: ✅ Accepted — can accelerate Class B–D approvals

• QM Note: QMS via ISO/MDSAP is essential

 

✅ 4. Malaysia (MDA)

• Foreign Certificates: Accepted

• ISO 13485: ✅ Required

• MDSAP: ✅ Accepted — supportive but not mandatory

• QM Note: Mandatory for Class B–D; Class A may only need basic documentation

 

✅ 5. Saudi Arabia (SFDA)

• Foreign Certificates: Accepted

• ISO 13485: ✅ Required

• MDSAP: ⚠️ Accepted as supplementary

• QM Note: MDSAP does not replace local audit but helps

 

✅ 6. UAE (MoHAP)

• Foreign Certificates: Accepted

• ISO 13485: ✅ Required

• MDSAP: ⚠️ Not formally accepted

• QM Note: ISO required; MDSAP can be supportive

 

✅ 7. South Korea (MFDS)

• Foreign Certificates: Partially accepted

• ISO 13485: ✅ Required

• MDSAP: ❌ Not officially accepted

• QM Note: ISO 13485 needed; local audit required for high-risk devices

 

✅ 8. Brazil (ANVISA)

• Foreign Certificates: Partially accepted

• ISO 13485: ✅ Required

• MDSAP: ✅ Accepted — waives local GMP inspection for some devices

• QM Note: Participation in MDSAP is strategic

 

✅ 9. China (NMPA)

• Foreign Certificates: ❌ Rarely accepted

• ISO 13485: ✅ Required

• MDSAP: ❌ Not accepted

• QM Note: Local GMP inspection usually mandatory

 

✅ 10. India (CDSCO)

• Foreign Certificates: ❌ Limited

• ISO 13485: ✅ Required

• MDSAP: ❌ Not accepted

• QM Note: QMS certificate must be included in the application dossier