Once your Class II medical device registration is approved by the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) in Indonesia, there are several important steps, requirements, and post-approval responsibilities you need to be aware of. Ensuring compliance with these requirements is crucial for maintaining the validity of the registration and for the continued smooth operation of your product in the Indonesian market.

1. Maintain Compliance with Post-Market Surveillance (PMS) Requirements

After registration, BPOM requires ongoing post-market surveillance (PMS) to ensure that the medical device continues to meet safety and effectiveness standards during its use in the market. The key aspects of post-market surveillance include:

• Adverse Event Reporting:
  • Manufacturers, distributors, or authorized representatives must monitor and report any adverse events or side effects related to the use of the device. This includes any incidents that may harm patients or users.
  • Reports of adverse events must be submitted to BPOM within a reasonable timeframe, typically within 15 days of becoming aware of the issue.
• Product Recalls:
  • If safety concerns arise or if a defect is discovered in the device after it is on the market, BPOM may require a recall of the product.
  • Manufacturers must comply with BPOM's recall procedures, which involve notifying distributors, healthcare providers, and users, and then retrieving defective or unsafe devices from the market.
• Market Monitoring and Reporting:
  • Ongoing monitoring of the device’s performance in the market is essential. This includes gathering feedback from users, healthcare professionals, and distributors regarding the device’s safety, effectiveness, and performance.
  • BPOM may require periodic safety and performance reports from the manufacturer or the local authorized representative.

2. Renewal of Registration Certificate

The registration certificate for Class II medical devices in Indonesia is valid for 5 years from the date of approval. As the expiration date approaches, you must initiate the process for renewing the registration. Here’s what you need to consider:

• Application for Renewal:

  • Submit a renewal application to BPOM well before the 5-year expiration. BPOM may request updated documentation, including evidence of ongoing compliance with regulatory requirements (e.g., updated clinical data, ISO certifications, or any new safety information).

• New Documents for Renewal:

  • BPOM may request new certificates, such as Certificate of Free Sale, ISO 13485, and GMP certificates that are still valid.
  • If there are significant changes to the device (e.g., modifications, new features, or packaging), BPOM may require new clinical evaluations or safety assessments.

• Timely Renewal:

  • Ensure the renewal process is initiated early to avoid any gaps in the validity of your device’s registration, as you cannot legally market or distribute the device in Indonesia without an active registration certificate.

3. Labeling and Instruction for Use (IFU) Compliance

Once the device is approved and registered, local labeling and instructions for use (IFU) must be compliant with Indonesian regulations:

• Bahasa Indonesia:

  • The device labeling, including the product name, instructions for use, and warnings, must be in Bahasa Indonesia. BPOM may require specific formats or elements to be included on the label (e.g., manufacturer’s details, lot number, expiration date, etc.).

• Post-Approval Changes in Labeling:

  • Any changes to the labeling or packaging (e.g., updated instructions, new language, added warnings) must be reported to BPOM. In some cases, approval may be required before these changes can be made public.

• Symbol Compliance:

  • Ensure that the symbols on your labels (e.g., storage instructions, handling symbols, warnings) comply with the ISO 15223-1 standard and BPOM's regulations.

4. Distributor and Authorized Representative Responsibilities

• Authorized Representative (AR):

  • If your company is a foreign manufacturer, you must designate a local authorized representative (AR) in Indonesia. The AR is responsible for managing communication with BPOM, ensuring regulatory compliance, and maintaining documentation.

• Distribution and Importation:

  • If your device is being imported into Indonesia, you must ensure that your importer has the proper licenses from BPOM. The importer must also comply with BPOM regulations, including labeling requirements and distribution controls.

• Monitoring and Reporting:

  • The distributor must also monitor the performance of the device in the market, manage returns, and assist in the adverse event reporting process when necessary.

5. Advertising and Promotional Materials

After registration, any advertisements or promotional materials related to your medical device must comply with Indonesian advertising regulations for medical devices:

• Claims and Warnings:
  • Any promotional claims about the device must be accurate and not misleading. Ensure that claims made in advertising, brochures, or product information are supported by clinical data and regulatory approval.
• Approval of Promotional Materials:
  • BPOM may require that you submit certain advertising materials for approval before they are used publicly. The materials must comply with health and safety guidelines to prevent misleading or unauthorized claims.

6. Clinical Data and Updates

• Ongoing Clinical Monitoring:

  • If your device has clinical data supporting its registration, ensure that you continue monitoring its clinical performance. If any new safety or efficacy issues arise, they should be communicated to BPOM in line with the adverse event reporting requirements.

• New Clinical Data:

  • If new clinical data becomes available (e.g., post-market clinical studies), you may need to update your registration. This could include submitting additional clinical evaluation reports (CER) or other related documents.

7. Conducting Device Modifications or Variations

If you make any changes to the design, composition, or intended use of the device, you will need to:

• Notify BPOM: Significant changes to the device, such as modifications to its design, materials, or intended use, may require a new registration application or a modification of the current registration.

• Re-Approval: In some cases, BPOM may require re-approval of the device, which could involve a review of updated technical documentation, clinical data, or new labeling.

8. Inspections and Audits

• Inspection of Manufacturing Facility:
  • BPOM may conduct routine inspections of the manufacturing facility or warehouse (especially for imported devices) to ensure compliance with Good Manufacturing Practices (GMP). Ensure your facility remains compliant with these standards to avoid potential delays or penalties.
• Inspection for Adverse Events:
  • BPOM may also request inspections or additional testing if there are concerns regarding adverse events or device quality.

9. Export and Distribution to Other Markets

Once the device is registered in Indonesia, if you plan to export the product to other countries, you may need to provide documentation from BPOM to show that your device is legally marketed in Indonesia:

• Certificate of Free Sale:
  • If requested by foreign authorities, you may need to provide an up-to-date Certificate of Free Sale issued by BPOM to demonstrate that the device is compliant and registered in Indonesia.

Summary of Post-Approval Considerations

1. Post-Market Surveillance (PMS): Report adverse events, monitor device performance, and comply with post-market reporting requirements.
2. Registration Renewal: Apply for renewal of the registration before it expires (valid for 5 years).
3. Labeling and IFU: Ensure that labels and instructions are compliant with Bahasa Indonesia requirements.
4. Authorized Representative & Distributor: Ensure compliance with local distributor and AR responsibilities.
5. Advertising and Promotional Materials: Comply with regulations and submit promotional materials for approval if necessary.
6. Device Modifications: Notify BPOM of any significant changes to the device.
7. Clinical Monitoring: Provide updated clinical data if necessary.
8. Facility Inspections: Be prepared for BPOM inspections to ensure ongoing compliance.

By staying informed of these post-approval requirements and fulfilling your obligations, you can ensure the continued legal distribution and sale of your medical device in Indonesia. Would you like more details on any specific part of the post-approval process?

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