Conditions to Apply for Class A Medical Device Registration with Indonesia MOH

To apply for Class A medical device registration with Indonesia’s Ministry of Health (MOH), several regulatory conditions and requirements must be met. These conditions ensure that the device complies with Indonesian health, safety, and quality standards. Below are the key conditions you must fulfill to apply:

1. Device Classification Confirmation

• Class A Classification: Ensure the medical device is classified as Class A under Indonesian regulations. Class A devices are considered low-risk and typically involve basic health or diagnostic tools.
• Correct Classification: Confirm the classification by referring to MOH regulations or consulting with a local regulatory expert. If your device falls under Class B, C, or D, the registration process will differ and require additional documentation.

2. Appointment of a Local Authorized Representative

• Local Presence Requirement: Foreign manufacturers must appoint a local authorized representative (distributor or regulatory consultant) in Indonesia.
  • The representative must be registered with the Indonesian Ministry of Health (MOH).
  • The authorized representative will serve as the legal license holder for the device and handle all regulatory interactions with the MOH.

3. Compliance with Indonesian Regulations

• Ensure that the device complies with Indonesian medical device regulations, including:
  • Regulation No. 62/2017 (on the supervision of medical devices and household health supplies).
  • Any additional technical or safety standards relevant to the device type (e.g., electrical safety, sterility).

4. Product Documentation and Translation

• All documents related to the product must be accurate and comply with MOH requirements:
  • Device Description: Clear description of the device, intended use, model, and specifications.
  • Instructions for Use (IFU): Detailed manual in Bahasa Indonesia.
  • Labels: Labels must include essential information (device name, manufacturer, local representative, lot number) and be translated into Bahasa Indonesia.
  • Risk Management Documentation: The device must have a risk assessment in line with ISO 14971 (if applicable).
  • Performance Data: Test reports confirming the device's safety and efficacy (e.g., electrical safety, biocompatibility).

5. ISO 13485 Certification

• Quality Management System (QMS): The manufacturer must have an ISO 13485 certificate, which demonstrates compliance with international quality management standards for medical devices.
  • The ISO 13485 certification is mandatory for all medical device manufacturers.
  • The certificate should be issued by a recognized body and must be up to date.

6. Certificate of Free Sale (CFS)

• CFS Requirement: A Certificate of Free Sale (CFS) must be obtained from the relevant health authority in the country of origin.
  • The CFS proves that the medical device is legally sold in the manufacturer's home country.
  • The certificate must be notarized and, if required, legalized by the Indonesian embassy in the country of origin.

7. Safety and Performance Documentation

• Test Reports: Provide evidence that the device meets relevant safety, performance, and technical standards (e.g., electrical safety, biological compatibility, packaging integrity).
  • If the device involves new or advanced technology, additional clinical data may be required.

8. Compliance with Post-Market Obligations

• Post-Market Surveillance: You must be prepared to meet post-market requirements, including:
  • Monitoring the device’s performance once it is marketed.
  • Reporting any adverse events to the MOH.
  • Participating in periodic updates or audits as required by Indonesian law.

9. Indonesian Language Requirements

• Documents in Bahasa Indonesia: All documents submitted, including the IFU, labels, and application form, must be translated into Bahasa Indonesia by a certified translator.

10. No Pending Violations or Sanctions

• Ensure that the manufacturer and authorized representative have no pending regulatory violations or sanctions in Indonesia or other markets.

11. Regulatory Fees

• Registration Fees: The application requires payment of the registration fee through the ASPAK system. Fees are typically low for Class A devices but can vary based on device specifics.

Summary of Conditions to Apply for Class A Medical Device Registration:

1. Correct classification of the device as Class A.
2. Appointment of a local authorized representative registered with MOH.
3. Compliance with Indonesian medical device regulations and international standards.
4. ISO 13485 certification of the manufacturer.
5. Certificate of Free Sale (CFS) from the country of origin.
6. Complete documentation (device description, labeling, risk management file, performance data).
7. Translation of documents into Bahasa Indonesia.
8. No violations or sanctions against the manufacturer or authorized representative.

If you meet these conditions, you can proceed with submitting the registration application via the ASPAK system. Let me know if you need any assistance in preparing documents or navigating the application process!