Class II medical device registration in Indonesia does not specifically require annual audits as part of the standard registration process. However, there are certain ongoing compliance and regulatory requirements that manufacturers must follow to maintain the validity of the registration. Here's an overview of what is required:

1. Post-Market Surveillance

• Continuous Monitoring: After registration, manufacturers are required to implement post-market surveillance to monitor the safety and performance of the device once it is in the market. This includes tracking any adverse events or product complaints and reporting them to BPOM.
• Annual Reporting: While there are no specific requirements for an annual audit, you may be required to provide annual reports or updates related to post-market surveillance, especially if there are any significant changes to the product, its performance, or its risk profile.

2. Periodic Renewals and Updates

• Renewal Every 5 Years: The registration for Class II medical devices is valid for 5 years. To continue marketing the device in Indonesia, the manufacturer must apply for renewal before the registration expires. This may involve providing updated documents or information, but not necessarily an annual audit.
• Changes to the Device: If there are any changes to the device (e.g., design modifications, new indications for use, or manufacturing processes), the manufacturer must inform BPOM and may need to submit additional documentation. Significant changes could trigger an additional review or inspection by BPOM.

3. Manufacturing Site Inspections (if applicable)

• GMP Compliance: For foreign manufacturers, BPOM may require evidence of Good Manufacturing Practice (GMP) compliance, which could involve an inspection of the manufacturing facility. While this is not an annual audit, BPOM may conduct inspections during the initial registration process or during specific circumstances (e.g., if a complaint or safety issue arises).
• Ongoing Compliance: While there is no requirement for regular audits, BPOM may conduct inspections or ask for GMP certification updates as part of the post-market surveillance process if concerns arise.

4. Adverse Event Reporting

• Continuous Reporting: Manufacturers must have a system in place to report adverse events and other safety issues related to the device. This is part of the ongoing regulatory responsibility to ensure that the device remains compliant with health and safety standards.

5. Product Safety and Risk Management

• Manufacturers are responsible for ensuring that the device continues to meet safety and performance standards throughout its lifecycle. This is generally achieved through risk management and regular quality control processes.

Summary:

• Annual Audits: There is no requirement for annual audits of Class II medical devices in Indonesia.
• Post-Market Surveillance: Manufacturers must ensure continuous monitoring of the device's safety and effectiveness.
• Renewal: The registration must be renewed every 5 years, and any significant changes to the device must be reported to BPOM.
• Manufacturing Inspections: While BPOM may inspect the manufacturing facility during the initial registration or if issues arise, there is no routine requirement for annual audits.

In essence, the ongoing compliance obligations focus more on monitoring device performance, reporting safety data, and maintaining documentation rather than conducting formal audits every year.

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