Categories: Blog
Published 14 May 2024

REGULATORY UPDATE | Indonesian Medical Device Product Approval

In marketing Medical Device, IVD and Household Health Supplies products in the Republic of Indonesia, a Medical Device Product Approval is required, which serves to indicate that the medical device product to be circulated has met the standards and requirements for safety, quality, and benefit to the public.

Companies that wish to apply for a product approval for medical devices must first obtain access to Online Single Submission (OSS)have IDAK/IPAK/SDAK (permit for distribution of medical devices). Medical Device Product Approval has a maximum validity period of 5 years. If the validity period of the Medical Device Circulation Permit is not/has not been extended, the Medical Device is prohibited from being circulated.

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Factors that can cause a Medical Device, IVD and Household Health Supplies Product Approval to be declared invalid if:

  • Expiry date
  • Production Certificate has expired
  • IPAK validity period has expired
  • The term of appointment as a Distributor ends or is not extended
  • Product Approval revoked.

Factors that can cause the Medical Device, IVD and Household Health Supplies Product Approval to be revoked if:

  • Products that are circulated can cause harm to health
  • Data discrepancy at the time of application for registration of medical device product approval
  • Production Certificate revoked
  • IPAK revoked
  • Termination of appointment as Distributor.

In extending the Product Approval for Medical Device, IVD and Household Health Supplies, the owner of the product approval must immediately apply for an extension of the product approval for medical devices within 9 months before the expiration date. Before applying for an extension of the product approval for medical devices, the owner of the product approval must submit production reports electronically through the e-report system.