Medical Device Registration in Indonesia

In Indonesia, the health sector is heavily prioritized by the government. The production of medical devices by Indonesian companies steadily rises over the years. As the demand increases, it is not possible for local producers to provide for all of them. This is why Indonesia becomes an exciting market for international medical device manufacturers. Before putting their products in the market, it is important to note that Indonesia has a strict and complex medical device registration procedure. At Double M, we offer the service of assisting our clients register their medical devices to the Ministry of Health.

Procedures for Medical Device Registration in Indonesia

After all the documents are prepared, these are the procedures of registration:

  1. Login to OSS RBA account
  2. Upload registration documents
  3. Complete fee payment to the government
  4. Issuance of medical device license. The license is valid for 5 years

Requirements for Medical Device Registration in Indonesia

These are the documents required in order to register medical devices in Indonesia:

Business Identity Number (NIB), Company’s Tax ID (NPWP), Medical Device Distribution License (IDAK)

Free Sales Certificate, ISO 13485 certificate (for imported products)

Dossier from manufacturer, in accordance to the ASEAN Common Submission Dossier Template (CSDT) which includes:

  • Executive Summary
  • Device Labeling
  • Detailed Manufacturer Information
  • Essential Principles of Safety
  • Design Verification
  • Risk Analysis
  • Method of Destruction
  • Quality Management Certification
  • Market History Proof
  • Letter of Authorization (LoA)

How can Double M Help?

Medical device registration in Indonesia requires the preparation of multiple documents. Double M strives to help our clients throughout the whole process and submit the application successfully. Should you have any inquiries, please contact us.

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