To apply for Class C medical device registration in Indonesia, you will need to submit your application to the National Agency of Drug and Food Control (BPOM), which operates under the Ministry of Health (MOH). The application process is handled through BPOM’s e-Registration system.

Here’s where and how you can apply for Class C medical device registration in Indonesia:

Where to Apply:

1. BPOM's e-Registration System

   • The primary platform for submitting medical device registrations in Indonesia is BPOM's e-Registration System, which is an online portal. This system is used for the submission of all medical device registrations, including Class C devices.

2. BPOM Website

   • The official website of BPOM (Badan Pengawas Obat dan Makanan) is the portal where you can access all the relevant guidelines, instructions, and the e-Registration System. You can find the e-Registration system and registration guidelines for medical devices at:
     • BPOM Official Website: https://www.pom.go.id/

3. Local Authorized Representative (AR)

   • If you are a foreign manufacturer, you must appoint a local Authorized Representative (AR) who is registered in Indonesia. The AR will be responsible for submitting the application and managing communication with BPOM on your behalf.
   • Your AR can assist you in creating an account in BPOM’s e-Registration system, uploading necessary documents, and ensuring compliance with local regulations.

Steps to Apply via BPOM's e-Registration System

1. Register on the e-Registration Portal:

   • The Authorized Representative (AR) (for foreign manufacturers) needs to create an account on BPOM’s e-Registration system.
   • Go to the official BPOM website and navigate to the e-Registration section to start the registration process.

2. Prepare the Required Documentation:

   • Ensure that all necessary documents (such as the product technical file, clinical evaluation, risk management, and quality management system certifications) are prepared in accordance with BPOM’s requirements.
   • Documents need to be translated into Bahasa Indonesia.

3. Submit the Application:

   • The AR will fill out the registration form on the e-Registration portal, attach the required documentation, and submit the application for review.
   • Ensure all information is complete and accurate to avoid delays in processing.

4. Payment of Registration Fees:

   • The registration fee will be paid through the e-Registration portal. The amount varies depending on the type of device and registration category (Class C devices will generally have higher fees compared to lower-risk classes).

5. BPOM Review:

   • After submission, BPOM will review the application. They may request additional information or clarification if needed. During this stage, BPOM may also require additional testing or an inspection of the manufacturing facility.

6. Approval and Issuance of Marketing Authorization (NOM):

   • Once BPOM completes the evaluation and the application is approved, they will issue a Marketing Authorization (NOM - Nomor Registrasi Obat dan Makanan), which allows the device to be marketed and sold in Indonesia.

Contact Information for BPOM

If you need direct assistance, you can contact BPOM for further clarification regarding the registration process:

• BPOM Official Website: https://www.pom.go.id/
• BPOM Contact Information: BPOM provides contact details (phone numbers, email addresses) on their website under the "Contact Us" section.

Important Notes:

• Language Requirement: All documentation and product information submitted to BPOM must be in Bahasa Indonesia, including product labels, instructions for use, clinical evaluation reports, and risk management documents.

• Authorized Representative (AR): Foreign manufacturers are required to appoint a local AR in Indonesia, as BPOM will not accept registration applications from foreign entities directly.

• Timely Communication: Be prepared to promptly respond to any requests for additional information from BPOM, as delays in responding may extend the registration process.

By submitting your Class C medical device registration through BPOM’s e-Registration system, you will be able to comply with Indonesian regulatory requirements for medical device marketing and distribution. Let me know if you need more specific guidance on the process!

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn