Medical Device Registration in
Malaysia
Ministry of Health:
Kementerian Kesihatan Malaysia
Regulatory Authority:
Medical Device Regulation:
Medical Device Regulation 2012
Official Language:
Malay
Classification:
Class A, B, C and D
Registration Process:
- Appoint a local authorized representative (LAR).
- Ensure products conform to Essential Principle of Safety & Performance (EPSP)
- Engage an accredited Conformity Assessment Body (CAB). CAB must be different from CAB in foreign countries.
- Complete application on MeDC@St system
- MDA verifies classification and upon approval issues a certificate and assigns a registration number.
Documents Required:
- Product Information
- Information on manufacturer
- Grouping of medical device
- Information on Validation (For Class A Sterile)
- Common Submission Dossier Template (CSDT)
- Post-market vigilance history
- Declaration of conformity
- Attestation for medical device registration
Post-market surveillance:
Failure of a medical device; deterioration in its effectiveness; inadequate labelling or IFU – 30 days
- Death or serious deterioration in state of health of patient – 10 days
- Serious threat to public health – 48 hours
Legalized/Notarised Documents (if any)
Certificate of Free Sales
Applicable QMS:
ISO 13485
Registration Timeline:
Class A – 6 to 8 weeks
Class B, C, D – 3 to 6 months
Authorized Representative:
Yes
License Validity:
5 years
Special Notes:
Guidance and Guideline are available for the Malaysian regulatory process