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Medical Device Registration in Malaysia

Ministry of Health: 

Kementerian Kesihatan Malaysia

Regulatory Authority:       

Medical Device Authority

Medical Device Regulation:

Medical Device Act 2012

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

Want to know more about this registration process?

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