After submitting an application for Class I medical device registration with the Indonesia Ministry of Health (MOH) through BPOM, there are several regulations and requirements that must be followed to ensure the successful approval and ongoing compliance of the medical device in the Indonesian market. These regulations cover both the registration process and the post-market requirements for medical devices.

Key Regulations and Requirements to Follow After Application for Class I Medical Device Registration with BPOM

1. Regulatory Compliance During the Review Process

• Timely Submission of Documents: Ensure that all required documents and supporting materials are submitted in a timely manner. If BPOM requests additional information or clarification, it is important to respond quickly to avoid delays in the approval process.
• Adherence to BPOM Guidelines: During the application process, the manufacturer and its local authorized representative (AR) must comply with all BPOM guidelines for medical device registration. These include the medical device registration manual and any specific requirements for the type of device being registered.
• Payment of Registration Fees: Ensure that all fees associated with the registration process are paid promptly, as failure to do so may delay or prevent approval. BPOM will only process the application after receiving the required fees.

2. Device Labeling and Packaging Regulations

• Labeling in Bahasa Indonesia: Once the device is registered, it is essential to ensure that all labels and instructions for use (IFU) are in Bahasa Indonesia (the official language of Indonesia). BPOM requires labeling to include key details such as:
  • Product name and brand.
  • Manufacturer details, including the name and contact information.
  • Intended use of the device.
  • Warnings, precautions, and contraindications.
  • Instructions for safe use and storage.
  • Expiry date (if applicable).
• Compliant Packaging: The packaging must also meet Indonesian standards. If the device is sterile, the packaging must clearly indicate its sterility status and include appropriate symbols.

3. Post-Market Surveillance Requirements

Once your device is registered and available in the Indonesian market, ongoing post-market surveillance (PMS) is required to monitor the device's safety, performance, and any potential adverse effects. This includes:

• Monitoring Product Performance: Continuously collect and review feedback on the device's performance in real-world conditions. This can include customer complaints, adverse events, and usage data.
• Reporting Adverse Events: If any adverse events (e.g., device malfunction, patient injury) occur, these must be reported to BPOM promptly. BPOM has specific guidelines for how adverse events should be reported.
  • If a device causes injury or death, a device recall may be required, and BPOM must be notified immediately.
• Adverse Event Reporting System: Ensure that an internal reporting system is in place to capture and address any complaints or safety issues from users. Devices must meet specific requirements for vigilance and reporting, in line with BPOM’s Medical Device Vigilance Guidelines.

4. Device Recall Procedures

• Recalls and Corrective Actions: If a product defect or safety issue arises that requires a recall, the manufacturer and the AR are responsible for coordinating the recall process. BPOM must be notified, and a corrective action plan must be implemented.
• Traceability: Ensure that all devices are traceable, and that records are kept of the distribution chain. This will facilitate rapid action if a recall is necessary.

5. Good Manufacturing Practices (GMP) and Facility Inspections

• Compliance with GMP: Manufacturers are required to comply with Good Manufacturing Practices (GMP). This ensures that devices are consistently produced and controlled to the quality standards that are appropriate for their intended use.
  • BPOM Inspections: BPOM may conduct facility inspections to verify compliance with GMP, especially for imported devices or devices produced by foreign manufacturers. The local AR may be asked to arrange and facilitate such inspections.
• Documenting Manufacturing Practices: Keep records of manufacturing processes, quality control tests, and inspections to demonstrate compliance with GMP standards.

6. Ongoing Communication with BPOM

• Notifying Changes: If there are any changes to the device's design, manufacturing process, or intended use, these must be communicated to BPOM. For example:
  • Changes in the manufacturing process or facility location.
  • Any modification in the components or materials used in the device.
  • Updates to the device's indications or intended use.
• Updating Registration: Significant changes may require an amendment to the registration or a new application. BPOM must be informed and approval sought before marketing the modified product.

7. Renewal of Registration

• Registration Validity: Once approved, the Class I medical device registration is typically valid for 5 years. After this period, the manufacturer must apply for renewal to continue selling the device in Indonesia.
• Documents for Renewal: BPOM may require updated documents for renewal, such as:
  • Post-market surveillance data.
  • Any new safety reports or data on device performance.
• Timely Application: Ensure that the renewal application is submitted well in advance of the registration's expiration to avoid interruptions in market access.

8. Compliance with Importation Regulations

• Importation Compliance: Devices must be imported by a BPOM-licensed importer. The local AR must coordinate with the authorized importer to ensure that the device is properly imported into Indonesia.
• Customs Clearance: Ensure that the device complies with Indonesian customs regulations. This includes ensuring that proper documentation (e.g., CFS, registration certificates) accompanies the product and that any applicable import duties and taxes are paid.

9. Market Surveillance and Inspections

• BPOM Market Inspections: BPOM may conduct market surveillance activities, which include inspecting devices already sold and verifying that they comply with regulatory standards. This can include random audits, product testing, and checking if the device is being sold in compliance with the approved registration.
• Random Sampling and Testing: BPOM may also perform random testing of devices available in the market to assess compliance with product specifications and safety standards.

10. Ongoing Training and Education

• Training on Regulatory Updates: Regularly train your team, distributors, and local AR about any regulatory changes that may affect the device's registration or compliance with Indonesian law.
• Regulatory Affairs Team: Maintain an effective regulatory affairs team (either in-house or through your AR) to ensure ongoing compliance and timely response to any regulatory changes or inquiries from BPOM.

11. Communication with Stakeholders

• Distributors and Retailers: Ensure that all distributors, retailers, and users of your device are aware of the device’s approved indications, proper use, and safety instructions.
• Product Documentation Updates: Keep stakeholders informed of any changes to the product or new updates to the instructions for use (IFU) and product labeling.

12. Non-Compliance Penalties

• Non-Compliance Consequences: Failure to comply with Indonesian medical device regulations, including post-market surveillance and reporting requirements, can lead to penalties such as fines, market withdrawal, or suspension of the registration.
• Penalty for Mislabeling: If labeling or packaging is found to be non-compliant (e.g., not in Bahasa Indonesia or with incorrect content), BPOM may require corrective action or even recall the product from the market.

Summary of Key Regulations After Applying for Class I Medical Device Registration with Indonesia MOH (BPOM)

1. Adhere to BPOM guidelines and promptly respond to requests for additional documentation.
2. Ensure that device labeling and packaging comply with Indonesian regulations, including being in Bahasa Indonesia.
3. Implement post-market surveillance to monitor device performance and report adverse events to BPOM.
4. Recall procedures must be in place in case of device malfunctions or safety concerns.
5. Ensure ongoing compliance with Good Manufacturing Practices (GMP) and facilitate any inspections from BPOM.
6. Communicate any changes in device design, manufacturing, or intended use to BPOM.
7. Submit a renewal application before the expiration of the registration (usually after 5 years).
8. Ensure importation compliance with Indonesian customs and BPOM regulations.
9. Be prepared for market surveillance and inspections by BPOM to verify ongoing compliance.
10. Maintain a trained regulatory affairs team and ensure clear communication with stakeholders (distributors, retailers, and users).
11. Penalty risks for non-compliance, including fines or suspension of registration.

By following these regulations and requirements, you can ensure that your Class I medical device remains compliant with Indonesian regulations and successfully continues to be marketed in Indonesia.

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