Medical Device Registration in

Indonesia

Ministry of Health

Ministry of Health (MOH RI)

Regulatory Authority

Ministry of Health (MoH RI)

Medical Device Regulation

ASEAN Medical Devices Directive

Official Language

Indonesian

Classification

Class A,B,C,D

Registration Process

  • Determine the device classification
  • Appoint an Authorized Representative.
  • The marketing authorization can be carried out in the following ways:

Part 1: Premarket Control                                                                                          

  • Manufacturer License (ISO 13485 for QMS)
  • Distribution License (Good Distribution Practise)
  • Registration License (ASEAN CDST)

Part 2: Post market Control  

The ASEAN AMDD guideline is used for post-market control and includes

  • Sampling
  • Monitoring
  • Vigilance
  • Advertisement

Documents Required

  • Executive Summary
  • Device Labelling
  • Detailed Manufacturer Information
  • Essential Principles of Safety and Performance of Medical Device
  • Summary of Design verification and validation documents
  • Risk Analysis
  • Quality Management Certification
  • Declaration of Conformity
  • Letter of Confirmation for market history proof from the manufacturer
  • Letter of Safety confirmation from the manufacturer
  • Other Regulatory Authority approvals
  • Letter of Authorization

Applicable QMS

ISO 13485:2016

Registration Timeline

  • Class A- 15 days
  • Class B, C -30 days
  • Class D- 45 days

Authorized Representative

Yes

License Validity

5 years

 

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