To apply for B-class medical device registration in Indonesia through the Ministry of Health (MOH) and BPOM, the following conditions must be met:

1. Device Classification

• The device must be classified as a B-class medical device according to BPOM's risk classification system. B-class devices are those that present moderate risks to health and typically require standard documentation and compliance with safety and performance requirements.

2. Authorized Representative (for Foreign Manufacturers)

• If you are a foreign manufacturer, you must appoint a local authorized representative in Indonesia. This representative must be a legal entity registered with BPOM, responsible for managing the registration process and communication with BPOM.

3. Manufacturer Compliance

• The device must be manufactured in a facility that complies with Good Manufacturing Practices (GMP). If the manufacturer is overseas, proof of GMP certification from the relevant regulatory body (e.g., FDA, CE) must be provided.
• The manufacturing facility may be subject to inspection by BPOM if required.

4. Product Documentation

The following documentation must be provided:

• Device Information: Detailed description of the device, intended use, and risk classification.
• Free Sale Certificate (FSC): Issued by the regulatory authority in the country of origin, confirming the device is legally sold in the home market.
• ISO Certifications: ISO 13485 certification for medical device quality management systems is often required, especially for foreign manufacturers.
• Clinical Data: If applicable, clinical data or a clinical evaluation report supporting the device's safety and effectiveness.
• Risk Management: A documented risk assessment (typically following ISO 14971) demonstrating how potential risks associated with the device have been mitigated.
• Product Labeling and Instructions for Use: Labels and IFUs must be provided in Bahasa Indonesia, and must meet BPOM’s regulatory standards.

5. Device Safety and Efficacy

• The device must meet safety and performance standards required by BPOM. This can include:
  • Compliance with international standards such as IEC 60601 for electrical medical devices.
  • Evidence from clinical studies or performance testing that demonstrates the device is safe and effective for its intended use.

6. Post-Market Obligations

• Manufacturers must ensure that they have a post-market surveillance system in place to monitor the device's safety and performance after it has been approved and is on the market.

7. Registration Fees

• The applicant must be prepared to pay the applicable registration fees via the BPOM e-Registration portal.