No, B-class medical device registration in Indonesia does not require an annual review. However, there are certain requirements for post-market surveillance and renewal that manufacturers and importers must adhere to. Here's a breakdown of the key requirements:

1. Post-Market Surveillance (PMS)

• Ongoing Monitoring: Once the B-class medical device is registered and approved by BPOM, manufacturers and distributors must engage in post-market surveillance. This means monitoring the performance of the device in the market to ensure that it continues to meet safety and efficacy standards.
• Reporting Adverse Events: Manufacturers are obligated to report any adverse events or product failures to BPOM. This is an essential part of ensuring the ongoing safety of medical devices once they are in use by patients or healthcare providers.
• No Annual Review, But Continuous Reporting: While there is no mandatory annual review, BPOM can require updates or additional safety reports if there are significant changes in the device's performance, or if adverse events occur. Manufacturers must be proactive in ensuring that their device continues to comply with the required safety and quality standards.

2. Registration Renewal (Every 5 Years)

• Validity Period: The registration for a B-class medical device in Indonesia is valid for 5 years. After this period, manufacturers must submit a renewal application to maintain the product’s market authorization.
• Renewal Requirements: The renewal process typically involves verifying that the device is still in compliance with Indonesian regulations. If there are changes in the device's design, manufacturing process, labeling, or intended use, those modifications must be reported to BPOM.
• Documentation for Renewal: Manufacturers may need to submit updated technical documentation, safety reports, or any new clinical data that supports the continued safety and efficacy of the device.

3. Changes in Product or Manufacturer

• If there are any changes to the product (e.g., new versions or improvements), updates to the manufacturing process, or changes in the manufacturer’s information, these need to be reported to BPOM for review and approval.
• This may require the submission of new documentation or evidence for approval, depending on the nature of the changes.

Summary:

• No Annual Review: There is no mandatory annual review for B-class medical devices in Indonesia.
• Post-Market Surveillance: Manufacturers must engage in ongoing monitoring of the device’s performance and report adverse events.
• 5-Year Renewal: After five years, the device registration must be renewed, which may require submitting updated documents or demonstrating continued compliance.

It's important to ensure ongoing compliance with BPOM’s regulations to maintain the device’s market authorization in Indonesia.

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