In Indonesia, Class 3 medical devices do not require annual audits as part of the registration process itself, but there are ongoing regulatory obligations that manufacturers must comply with after the device is registered. These obligations may involve periodic inspections and audits under certain conditions, particularly related to Good Manufacturing Practice (GMP), post-market surveillance, and compliance with safety standards.

Here are the key points regarding audits and inspections after Class 3 medical device registration in Indonesia:

1. GMP Compliance Inspections

• While the initial registration process may involve a GMP inspection (especially if the device is manufactured outside Indonesia), annual GMP audits are not mandatory.
• However, if the device manufacturer is located outside Indonesia, BPOM may conduct periodic inspections of the manufacturing facility to ensure ongoing compliance with GMP standards.
• Manufacturers and local distributors must maintain documentation of GMP compliance, and BPOM has the authority to request audits or inspections at any time to verify that the manufacturer continues to meet these standards.

2. Post-Market Surveillance

• After registration, post-market surveillance is a crucial component of maintaining compliance for Class 3 devices. This involves monitoring the safety and performance of the device after it is released to the market.
• While annual audits are not required, manufacturers must regularly submit adverse event reports, product complaints, and recall notifications (if applicable).
• BPOM can request additional information or conduct inspections to ensure that any issues arising from the product's use are being properly addressed, including device recalls or safety concerns.

3. Re-registration Every 5 Years

• Class 3 medical devices must be re-registered every 5 years in Indonesia, which may involve updating the device's documentation, including clinical data, performance records, and labeling. This ensures that the device continues to meet regulatory standards.
• During the re-registration process, BPOM may conduct additional reviews or inspections to verify that the device is still compliant with Indonesian regulations and standards. While this isn't the same as an annual audit, it does require manufacturers to provide updated documentation and possibly undergo further evaluation.

4. Regulatory Inspections

• BPOM reserves the right to perform unannounced inspections or audits if there are concerns related to the safety, quality, or marketing of a medical device.
• Inspections may be triggered by reports of adverse events, safety issues, or concerns related to false advertising or non-compliant labeling. These inspections may occur anytime during the product's market life.

5. Compliance with ISO Standards

• Manufacturers of Class 3 devices are also expected to comply with international standards, such as ISO 13485 (for quality management systems) and ISO 14971 (for risk management). Although BPOM doesn’t mandate annual audits for these standards, manufacturers are expected to maintain internal audits and documentation as part of their compliance.
• If BPOM conducts a GMP inspection, they may review records related to quality management and risk management, ensuring compliance with the required ISO standards.

Summary:

• No mandatory annual audits for Class 3 medical device registration itself.
• GMP inspections may occur periodically, especially for foreign manufacturers.
• Post-market surveillance is required, with periodic reporting and potential audits based on safety concerns.
• Re-registration every 5 years with updated documentation.
• BPOM has the authority to conduct inspections or audits at any time if there are concerns about device safety or compliance.

While annual audits aren't required, manufacturers must ensure that they maintain ongoing compliance with regulatory and quality standards, and be prepared for inspections by BPOM if needed.

If you need more details on post-market obligations or other regulatory requirements, feel free to ask!

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