REGULATORY UPDATE | Indonesian Medical Device Product Approval

In the Republic of Indonesia, obtaining a Medical Device Product Approval is mandatory for marketing Medical Devices, In Vitro Diagnostics (IVDs), and Household Health Supplies. This approval indicates that the medical device has met the required standards for safety, quality, and public benefit.

Companies seeking product approval for medical devices must first access the Online Single Submission (OSS) system and obtain an IDAK/IPAK/SDAK (permit for distribution of medical devices). The validity of the Medical Device Product Approval is a maximum of five years. If the Medical Device Circulation Permit is not extended before its expiration, the medical device is prohibited from being circulated.

Factors Leading to Invalid Approval

Several factors can result in the invalidation of Medical Device, IVD, and Household Health Supplies Product Approval, including:

• Expiration of the approval date.
• Expiration of the Production Certificate.
• Expiration of the IPAK validity period.
• End of appointment term as a distributor without extension.
• Revocation of Product Approval.

Factors Leading to Revocation of Approval

Product Approval can also be revoked under certain conditions, such as:

• Products that pose health risks.
• Data discrepancies during the registration process for medical device product approval.
• Revocation of the Production Certificate.
• Revocation of the IPAK.
• Termination of the appointment as a distributor.

Extension of Product Approval

To extend the Product Approval for Medical Devices, IVDs, and Household Health Supplies, the product approval owner must apply for an extension at least nine months before the expiration date. Additionally, the owner must submit production reports electronically through the e-report system prior to applying for an extension.

By following these guidelines, companies can ensure compliance and maintain their product approvals in Indonesia.