To apply for Class 3 medical device registration with the Ministry of Health (MOH) of Indonesia through the Badan Pengawas Obat dan Makanan (BPOM), you must meet specific regulatory requirements and submit a comprehensive set of documents. Class 3 devices are considered high-risk medical devices, and their registration process is rigorous to ensure patient safety and device efficacy.

Here are the key requirements for applying for Class 3 medical device registration in Indonesia:

1. Appoint an Authorized Representative (for Foreign Manufacturers)

• Foreign manufacturers must appoint a local authorized representative in Indonesia to act as a liaison with BPOM. The authorized representative will be responsible for submitting the application, handling communication with BPOM, and ensuring that the device complies with Indonesian regulations.
• Indonesian manufacturers can apply directly to BPOM without the need for an authorized representative.

2. Compliance with Indonesian Regulatory Standards

• The device must comply with Indonesian medical device regulations, which are largely aligned with international standards such as:
  • ISO 13485: Quality Management Systems for medical devices.
  • ISO 14971: Risk management for medical devices.
  • IEC 60601-1: Standards for medical electrical equipment (if applicable).
  • Other relevant local regulations as defined by BPOM and MOH.

3. Registration Dossier Preparation

A complete registration dossier must be submitted to BPOM, including the following documents:

Device Description

• A clear and detailed description of the device, including its intended use, mechanism of action, and any special features (e.g., sterilization requirements).
• Specifications: Key technical characteristics and performance specifications of the device.

Manufacturing and Quality Information

• Manufacturing Process: Details about the device's design and manufacturing process, including information on raw materials, production, and testing procedures.
• ISO 13485 Certification: Evidence of compliance with ISO 13485 (Quality Management System for medical devices).
• Good Manufacturing Practice (GMP): Documentation that the manufacturing facility complies with GMP standards.

Clinical Data

• Clinical evidence supporting the safety and effectiveness of the device, especially if it involves new technologies or treatments. This may include:
  • Clinical trial reports.
  • Scientific literature supporting the device's claims.
  • Post-market surveillance data if the device has been marketed elsewhere.
• For Class 3 devices, clinical data is critical as they are considered high-risk devices.

Risk Management Documentation

• A risk management file in line with ISO 14971, identifying potential hazards and showing how risks are mitigated through design and testing.
• Include the results of any biocompatibility testing (for devices that come into direct contact with patients) and other relevant risk assessments.

Certificates and Approvals

• Certificate of Free Sale (CFS) from the country of origin (if the device is sold in another country), indicating that the device is legally marketed in that country.
• Declaration of Conformity: A statement by the manufacturer confirming the device meets the relevant regulations and standards (e.g., CE marking or FDA approval, if applicable).
• ISO Certifications (such as ISO 13485 and ISO 14971) or other recognized standards.
• Test Reports: Any safety or performance test reports, such as electrical safety tests for electrical medical devices (e.g., compliance with IEC 60601).

Product Labeling and Instructions for Use

• Labeling in Bahasa Indonesia (the official language of Indonesia).
• The labeling must include:
  • Device name, model, and serial number.
  • Manufacturer’s details and authorized representative (if applicable).
  • Intended use, storage conditions, and expiration date (if applicable).
  • Clear warnings, precautions, and instructions for use.
  • Contraindications and any special care instructions.

Packaging Information

• Information on packaging, including sterility (if applicable), storage conditions, and shelf life.

4. Submit the Application to BPOM

• Submit the complete registration dossier to BPOM via the e-registry system (if available) or through physical submission.
• If you are using an authorized representative, they will handle the submission on your behalf.

5. BPOM Evaluation Process

BPOM will assess the device's compliance with safety, performance, and regulatory requirements. The evaluation process includes:

• Review of the submitted documents (clinical data, risk management, ISO certifications, etc.).
• Additional data requests: BPOM may ask for further information or clarification regarding the device’s safety, efficacy, or risk profile.
• On-site inspection (if necessary): BPOM may inspect the manufacturing facility to verify compliance with GMP and other regulatory requirements.
• For high-risk devices like Class 3 devices, BPOM may request additional clinical trial data or performance testing before proceeding.

6. Issuance of Registration Certificate

• Once BPOM completes the evaluation, and if all requirements are met, BPOM will issue a registration certificate for the device. This certificate grants the legal right to market and distribute the device in Indonesia.
• Registration Validity: Typically, the registration is valid for 5 years, after which the manufacturer will need to apply for a renewal.

7. Post-Market Surveillance

• After the device is registered and on the market, the manufacturer must adhere to post-market surveillance requirements:
  • Adverse event reporting: Any negative events or issues with the device must be reported to BPOM.
  • Periodic updates: Manufacturers are required to submit updates on the device, including any new clinical data or changes in manufacturing processes.
  • Product recalls: If issues with the device arise, the manufacturer must initiate a recall if necessary.
  • Ongoing compliance: Periodic audits or inspections may be carried out by BPOM to ensure the device remains compliant with regulatory standards.

8. Renewal Process

• After the 5-year registration period expires, manufacturers must submit a renewal application with updated documentation to ensure continued compliance with regulations.

Key Considerations:

• Clinical Evidence: Class 3 devices require strong clinical data and scientific evidence to demonstrate safety and efficacy.
• Risk Management: A risk management file is essential to ensure all potential hazards are identified and mitigated.
• Compliance with Standards: Devices must meet international standards (e.g., ISO 13485, ISO 14971) and Indonesian regulations.
• Labeling: Labeling and instructions must be in Bahasa Indonesia and include all required information for safe use.
• Local Authorized Representative: A local representative is necessary for foreign manufacturers to facilitate communication with BPOM.

By ensuring that your device meets all these regulatory requirements, you can effectively apply for and obtain Class 3 medical device registration in Indonesia.

Let me know if you need further clarification on any of these points!

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