When applying for Class II medical device registration with Indonesia's Ministry of Health (MOH) through the National Agency of Drug and Food Control (BPOM), a comprehensive set of documents and materials is required. These materials must demonstrate the safety, efficacy, and regulatory compliance of the medical device.

Here’s a breakdown of the documents and materials required for registration, and how to prepare the application:

Documents and Materials Required for Class II Medical Device Registration in Indonesia

1. Cover Letter

• A formal letter from the manufacturer or authorized representative (AR) stating the intent to

• apply for registration.

• Contents: Include basic details of the device, the manufacturer, and the authorized representative.

2. Application Form

• BPOM provides an official application form for medical device registration, which must be filled out and submitted.
• You can find the form in the BPOM e-registration system or request it from BPOM directly.

3. Product Information

• A detailed description of the medical device, including:
  • Device name, model, and variations.
  • Intended use and classification (confirm that it is classified as Class II).
  • Technical specifications, components, and functionality.
  • Product lifecycle information.

4. Certificate of Free Sale (CFS)

• A Certificate of Free Sale from the country of origin (issued by the relevant regulatory authority), proving that the device is legally marketed and sold in the country where it is manufactured.
• The certificate should be recent (typically within 6 months) and include the product name and a statement of conformity.

5. ISO 13485 Certificate

• The manufacturer must provide proof of compliance with ISO 13485 (Quality Management System for medical devices), which ensures the manufacturer maintains appropriate quality control and meets regulatory standards.

6. Risk Management Report (ISO 14971)

• A report that outlines the risk management process for the device in compliance with ISO 14971. This includes identifying, assessing, and mitigating risks throughout the device’s lifecycle.

7. Clinical Evaluation Report (CER)

• A Clinical Evaluation Report may be required to demonstrate the safety and effectiveness of the medical device. This is particularly important if the device is novel or has not been marketed for an extended period.
• It should include:
  • Clinical data supporting the device’s intended use.
  • A summary of clinical trials or studies (if available).
  • A comparison with similar devices if applicable.

8. Good Manufacturing Practices (GMP) Certificate

• A certificate proving that the manufacturing facility adheres to Good Manufacturing Practices. This may be an international GMP certificate or a local certificate if the device is manufactured in Indonesia.

9. Product Labeling and Instructions for Use (IFU)

• Labeling: Labels that comply with Indonesian regulations, including clear product information, warnings, and intended use.
• Instructions for Use (IFU): A manual or guide in Bahasa Indonesia that includes all necessary instructions for proper use of the device.
  • Ensure the IFU includes details such as:
    • Indications for use.
    • Contraindications and warnings.
    • Storage conditions and shelf life.
    • Directions for cleaning, maintenance, and disposal.

10. Declaration of Conformity

• A declaration from the manufacturer stating that the device complies with relevant Indonesian regulations (e.g., BPOM, Ministry of Health regulations, and applicable international standards).

11. Import License or Distribution Agreement (if applicable)

• If the device is imported into Indonesia, the importer must provide their import license. Alternatively, a distribution agreement between the manufacturer and the local distributor (if the manufacturer is not directly involved in the Indonesian market) must be included.

12. Other Supporting Documents (If Required)

• Additional documents may be requested by BPOM based on the nature of the device. These could include:
  • CE Marking or other international certifications, if applicable.
  • Product samples for testing or evaluation, if requested by BPOM.
  • Test reports from accredited laboratories (e.g., for electrical safety, biocompatibility, or performance testing).

How to Prepare the Application for BPOM

Step 1: Gather All Required Documents

• Ensure that you have all required documents listed above in the correct format. Any missing or incomplete documents will delay the registration process.
• All documents must be accurate, valid, and appropriately translated into Bahasa Indonesia (if necessary), including labels, IFUs, and any other product-related materials.

Step 2: Translate Documents into Bahasa Indonesia

• Translations: Any documents or product materials (like labels, IFU, CFS, etc.) that are not in Bahasa Indonesia must be translated.
  • Ensure translations are accurate and official. Poor translations or errors in the documentation can lead to delays or rejection.

Step 3: Create a BPOM Account (For e-Registration)

• Log into BPOM’s e-registration platform to create an account. This online platform allows you to submit your documents electronically.
  • Website: www.pom.go.id
  • Complete the online registration and application form.
  • Attach all required documents to the online platform.

Step 4: Submit the Application

• Submit your complete application via the BPOM e-registration system or, if necessary, submit manually at the BPOM office in Jakarta or the appropriate regional office.
• Pay any registration fees as required by BPOM. Fees for Class II medical devices typically range from IDR 5,000,000 to IDR 15,000,000 (approximately USD 300 to USD 1,000), depending on the type and complexity of the device.

Step 5: Respond to BPOM Requests

• BPOM may request additional information, clarification, or corrections during the document review process.
• Be responsive to BPOM’s requests to ensure the application is processed efficiently.

Step 6: Factory Inspection (If Required)

• If BPOM requires a factory inspection for Good Manufacturing Practices (GMP) compliance or other reasons, be prepared for an inspection by BPOM’s team. This may involve submitting additional documents or scheduling a visit to your manufacturing site.

Step 7: Receive the Registration Certificate

• Upon successful review and approval, BPOM will issue the Registration Certificate (STP), which allows you to market and distribute your device in Indonesia.
• The registration certificate is valid for 5 years, after which you will need to apply for renewal.

Precautions When Preparing the Application

1. Ensure Complete Documentation: Incomplete or incorrect submissions can delay approval. Double-check each document before submission.
2. Translate All Materials Accurately: All relevant documents, including labels and user instructions, must be translated into Bahasa Indonesia. Hire a professional translator if needed to avoid errors.
3. Check for GMP Compliance: If your device is manufactured outside Indonesia, ensure the manufacturing facility complies with international Good Manufacturing Practices (GMP). BPOM may request a GMP certificate.
4. Follow BPOM Guidelines: Ensure your application complies with BPOM’s regulatory requirements. Non-compliance may result in rejection or delays.
5. Consult with a Local Representative or Consultant: If you're unfamiliar with the process or regulatory language, working with a local authorized representative or a regulatory consultant can help ensure a smooth process.

By ensuring you have all the necessary documents, translating everything into Bahasa Indonesia, and submitting the complete application correctly, you can successfully register your Class II medical device with BPOM in Indonesia. Would you like further guidance on any specific document or step in the process?

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