Once your D-class medical device registration with the Ministry of Health (MOH) in Indonesia has been approved, there are several important steps and ongoing responsibilities to be aware of. These post-registration requirements ensure that your device remains compliant with local regulations and that it can be marketed and sold without issues.

Key Points to Note After D-Class Medical Device Registration is Approved:

1. Obtain the Registration Certificate (SKT)

• After approval, BPOM will issue a Registration Certificate (Surat Keterangan Terdaftar, SKT) for your medical device. This certificate is proof that your device is legally registered for sale in Indonesia.
• Keep a copy of the SKT and display it on your product packaging or marketing materials as proof of compliance.
• If any updates or renewals are required, ensure to track the expiration date of the registration certificate and initiate renewals in a timely manner.

2. Ensure Compliance with Indonesian Labeling and Packaging Requirements

• Labeling: As a registered device, you must ensure that all labels on your product (including packaging) meet Indonesian regulatory requirements:
  • Labels must be in the Indonesian language or accompanied by an official translation.
  • The label should include essential information such as the product name, manufacturer details, batch/serial number, expiration date (if applicable), and usage instructions.
• Instructions for Use (IFU): The IFU must be in Indonesian and comply with local standards. Make sure to include safety warnings, handling instructions, and storage requirements.
• Symbols: The use of symbols on packaging and labeling must follow ISO 15223-1, as it ensures universal understanding across various languages.

3. Post-Market Surveillance (PMS) and Vigilance

• Even after registration, you are obligated to conduct post-market surveillance to ensure that your device continues to meet safety, effectiveness, and performance standards:
  • Monitor for Adverse Events: Report any adverse events or device failures to BPOM, especially if these issues can affect user safety or the performance of the device.
  • Corrective Actions: If issues arise post-market, such as safety concerns or defects, you must implement corrective actions like device recalls, repairs, or product modifications and notify BPOM.
  • Periodic Reporting: Depending on the device type, you may need to submit periodic reports on the device's performance, safety, and any post-market issues to BPOM.

4. Regulatory Renewal and Maintenance

• Registration Validity: Medical device registrations in Indonesia are typically valid for 5 years from the date of approval. Before the expiration date, you must apply for a renewal.
• Renewal Process: The renewal application will require updated documentation, including the latest Certificate of Free Sale (CFS) from the manufacturer’s home country and updated performance data (if applicable).
• Changes to the Product: If there are any significant changes to the device (e.g., design, intended use, manufacturing process), you may need to submit an updated registration application or an amendment to BPOM.

5. Compliance with Indonesian Advertising and Promotion Laws

• Advertising Approval: Ensure that all promotional materials (e.g., brochures, websites, advertisements) related to your registered device comply with Indonesian advertising laws. Any claims made about the device's effectiveness or features must be truthful and substantiated.
• Marketing Restrictions: Do not make any misleading or unsubstantiated claims about the device’s safety or efficacy. The Indonesian government strictly regulates medical device advertising to ensure that it aligns with public health interests.

6. Importation and Distribution

• If your device is being imported into Indonesia, you must follow all importation procedures regulated by BPOM:
  • Work with a local authorized distributor who is registered with BPOM.
  • Ensure that the device is imported through approved channels, and customs documentation must reflect the registered device’s details.
• Regular inspection of imported products by BPOM may occur to verify compliance with the registration standards.

7. Customs and Import Duties

• Once the device is registered, importers must ensure that the device complies with customs regulations and that applicable import duties and taxes are paid when bringing the product into Indonesia.
• Ensure that customs declarations accurately reflect the device’s registration status.

8. Ongoing Communication with BPOM and Authorities

• Update BPOM: If there are any changes to your company or product (e.g., manufacturer details, changes in the supply chain, new manufacturing sites), inform BPOM about these updates.
• Regular Audits and Inspections: BPOM may conduct audits or inspections of your facility (or the facilities of your local distributor) to ensure compliance with medical device regulations.

9. Liability and Insurance

• Ensure that your device is covered by appropriate product liability insurance in Indonesia. While this is not explicitly required for registration, it is recommended to protect your business in case of legal issues or adverse events.
• In case of a device recall or an adverse event, having proper insurance will ensure your company is financially prepared to handle any liabilities.

Summary of Post-Registration Responsibilities:

1. Obtain and maintain the Registration Certificate (SKT).
2. Ensure compliance with Indonesian labeling and packaging regulations.
3. Monitor device safety and perform post-market surveillance, reporting adverse events to BPOM.
4. Apply for renewal of registration 5 years before expiry.
5. Comply with advertising and promotion regulations for medical devices.
6. Work with a local distributor or authorized representative for importing and distribution.
7. Notify BPOM of any significant changes to the device or company.
8. Ensure product liability insurance coverage and be prepared for any corrective actions or recalls.

By adhering to these post-registration requirements, you can help ensure that your D-class medical device remains compliant with Indonesian regulations, maintains its market authorization, and is safely distributed to Indonesian consumers.

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