To apply for Class II medical device registration in Indonesia, the process must be carried out through the National Agency of Drug and Food Control (BPOM). Below is a comprehensive guide on how to apply and where to apply for Class II medical device registration in Indonesia.

Where to Apply for Class II Medical Device Registration in Indonesia?

You need to submit your Class II medical device registration application to BPOM (Badan Pengawas Obat dan Makanan), which is the regulatory authority overseeing the approval of medical devices in Indonesia.

The application can be done through the BPOM's e-registration system (online registration platform), or in some cases, manual submission may be required. BPOM handles all registration activities for medical devices in Indonesia, including Class II devices.

Where to apply:

1. BPOM Online Registration System (e-registration):
   • BPOM has an online platform for medical device registration called e-registration.
   • The system allows for the electronic submission of documents and processing of medical device registration applications. It’s the preferred method for applying for Class II medical device registration.
   • Website: www.pom.go.id (Official BPOM website)
   • You will need to create an account on the BPOM e-registration portal and submit all required documents electronically.
2. Manual Submission (if applicable):
   • In some cases, BPOM may request or allow for manual submission of the registration application.
   • BPOM Jakarta Office: The main BPOM office is located in Jakarta, and you may need to submit physical copies of documents there if manual submission is required.
     • Address: Badan Pengawas Obat dan Makanan (BPOM)
       • Jalan Percetakan Negara No. 23
       • Jakarta Pusat, Indonesia
   • However, e-registration is usually the faster and preferred method for Class II devices.

Steps to Apply for Class II Medical Device Registration in Indonesia

Step 1: Appoint a Local Authorized Representative (AR)

• Foreign manufacturers are required to have a local authorized representative (AR) or importer in Indonesia.
• The AR will act as the official liaison between BPOM and the manufacturer, handling the application process, document submissions, and communication with BPOM.

Step 2: Prepare Required Documents

You must submit a complete set of documents as required by BPOM for Class II medical devices. These documents typically include:

1. Cover Letter from the manufacturer or AR.
2. Product Information: Detailed description, model variations, intended use, and technical specifications.
3. Certificate of Free Sale (CFS) from the country of origin.
4. ISO 13485 Certificate for quality management system compliance.
5. Clinical Evaluation Report (CER), if required.
6. Risk Management Report (ISO 14971 compliance).
7. Good Manufacturing Practices (GMP) Certificate.
8. Product Labeling and Instructions for Use (IFU) in Bahasa Indonesia.
9. Import License or Distribution Agreement (if applicable).
10. Regulatory Application Form completed through BPOM’s platform.

Step 3: Register Online via BPOM e-registration System

• Create an account on BPOM’s e-registration portal.
• Complete the online application form and upload all required documents.
• Ensure that all documents are in the correct format and translated into Bahasa Indonesia (if necessary).
• Pay the registration fee (the fees typically range from IDR 5,000,000 to IDR 15,000,000 depending on the device and complexity).

Step 4: BPOM Review and Evaluation

• BPOM will review the submitted documents and may request additional information or clarifications if necessary.
• BPOM may also require a factory inspection to ensure that the manufacturing facility complies with Good Manufacturing Practices (GMP).

Step 5: Receive Registration Certificate

• After BPOM has reviewed the application and confirmed compliance with Indonesian medical device regulations, they will issue the Registration Certificate (Surat Tanda Pendaftaran, STP).
• This certificate grants approval to market and distribute the device in Indonesia.
• The registration certificate is typically valid for 5 years, after which a renewal is required.

Precautions and Tips

1. Work with a Local Authorized Representative (AR): For foreign manufacturers, it’s crucial to have a local representative who is familiar with BPOM's processes and can manage the registration on your behalf.

2. Ensure Complete Documentation: Make sure all required documents are accurate, complete, and in the correct format. Missing or incorrect documentation can delay the registration process.

3. Bahasa Indonesia Translations: All relevant documents (such as product labels, IFUs, and certificates) must be translated into Bahasa Indonesia. It’s important to use professional translation services to avoid errors.

4. BPOM Helpdesk: If you have questions or need support during the registration process, BPOM offers a helpdesk that can assist you with technical issues or clarify requirements.

5. Follow Up: Stay in touch with BPOM or your AR to monitor the status of your registration application. BPOM may request additional information or clarification, so being responsive is important.

Summary of Where and How to Apply

• Where: Submit your application to BPOM via the e-registration system on the BPOM website, or through manual submission to BPOM’s Jakarta office if required.
• How:
  1. Appoint a local authorized representative (AR).
  2. Prepare all required documents and ensure they are complete and in Bahasa Indonesia.
  3. Submit your application through BPOM’s online registration system.
  4. Pay the registration fees.
  5. BPOM reviews the application, may request additional information, and eventually issues a registration certificate.

By following these steps and working with a local representative, you can effectively navigate the Class II medical device registration process in Indonesia. Would you like assistance with any specific aspect of the registration or details on how to find an authorized representative?

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