No, D-class medical device registration in Indonesia does not require annual renewal. The registration for D-class devices is typically valid for 5 years from the date of approval. After this period, the registration must be renewed, but annual renewal is not necessary.

Key Points about D-Class Medical Device Registration and Renewal:

1. Initial Registration: Once registered, the device is approved for sale and distribution in Indonesia.

2. Validity Period: The registration is valid for 5 years from the approval date.

3. Renewal Process: After 5 years, the device's registration must be renewed to continue selling it in the market. The renewal process is typically a simpler version of the original registration process, but it still requires submitting updated documentation.

4. Post-Market Surveillance: While the registration itself is not renewed annually, the device is still subject to post-market surveillance by BPOM. Manufacturers or local distributors must report any adverse events, device failures, or safety issues as part of the ongoing regulatory compliance.

5. Changes in Regulatory Requirements: If there are any regulatory updates or changes during the 5-year period, manufacturers may be required to comply with the updated regulations, but these changes do not necessitate annual renewals. The renewal process focuses mainly on confirming that the product is still in compliance with the existing regulations.

In Summary:

• No annual renewal is required for D-class medical devices.
• Renewal is required only after 5 years, during which the manufacturer must submit the necessary documents for continued market access.
• Post-market surveillance and reporting of adverse events are ongoing responsibilities throughout the device's lifecycle.

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