To register and apply for Class C medical device registration in Indonesia under the Ministry of Health (MOH), the process involves several steps, including preparing documentation, submitting applications via BPOM’s e-Registration system, and fulfilling other regulatory requirements. Here is a step-by-step guide on how to register a Class C medical device in Indonesia:

Step-by-Step Process for Class C Medical Device Registration in Indonesia:

1. Appoint a Local Authorized Representative

If you are a foreign manufacturer, you must appoint a local authorized representative or distributor in Indonesia. This is a mandatory requirement because foreign manufacturers cannot submit an application directly to BPOM without a local representative.

• The local representative will be the primary point of contact for BPOM and will handle the submission of the registration application, as well as any communication during the process.
• Requirements: The representative should be a company legally registered with BPOM in Indonesia.

2. Classify the Device

Ensure that your device is classified as a Class C medical device. BPOM uses a classification system based on the level of risk associated with the device:

• Class C devices are considered moderate-risk medical devices, such as diagnostic equipment, therapeutic devices, or certain surgical instruments. These devices require detailed documentation and data to ensure safety and efficacy.
• Device Classification: Verify the classification of your device by referring to Indonesian regulations or consulting BPOM if needed.

3. Prepare Required Documents

Prepare the necessary documentation required for registration. The key documents for Class C medical device registration include:

1. Device Description:

   • Detailed description of the device, its intended use, components, and operation.

2. Manufacturer Information:

   • Name and address of the manufacturer, certification of compliance, and declaration of conformity.
   • If applicable, a Market Authorization Certificate from other countries where the device is approved (e.g., FDA, EMA, PMDA).

3. Clinical Data (if applicable):

   • Clinical data demonstrating the safety and efficacy of the device. If clinical data is not required, provide a Justification Letter explaining why it is not applicable.

4. ISO Certifications:

   • ISO 13485: Evidence of compliance with international Quality Management System (QMS) standards.
   • ISO 14971: Risk management documentation to assess and control potential risks related to the device.

5. Good Manufacturing Practice (GMP):

   • GMP Certification from the manufacturing site. If the manufacturing facility is located outside Indonesia, BPOM may accept GMP certificates from recognized regulatory authorities (e.g., FDA, EMA).

6. Labeling Information:

   • Product labels and instructions for use, including translations into Bahasa Indonesia.

7. Other Relevant Documents:

   • A Declaration of Conformity confirming that the device meets relevant Indonesian standards and international regulations.

4. Submit the Application through BPOM’s e-Registration System

BPOM requires all medical device registrations to be submitted through their e-Registration system. Here’s how to submit your application:

1. Create an Account:

   • The applicant (or local representative) must first create an account on BPOM’s e-Registration portal.
   • If you do not have an account, you must register on the system and follow the instructions to set up your profile.

2. Complete the Application Form:

   • Fill out the required details in the online application form, including device specifications, manufacturer details, and local representative information.

3. Upload Documents:

   • Upload all required documents in the system, such as device description, clinical data, certifications, GMP certificate, and labeling information.

4. Payment of Fees:

   • After submitting the form and documents, BPOM will calculate the applicable registration fees. You must pay the fees through the BPOM e-Registration portal.
   • Accepted payment methods typically include bank transfer or online payment systems.

5. BPOM Review Process

Once the application is submitted, BPOM will initiate a review process. The review process generally involves the following stages:

1. Administrative Review:

   • BPOM will first verify if the application is complete and whether the required documents are in order.
   • If any documents are missing or need clarification, BPOM will request additional information from the applicant.

2. Technical and Scientific Evaluation:

   • BPOM will review the technical specifications of the device to ensure compliance with local standards and regulations.
   • Clinical data and risk management documentation will be thoroughly evaluated to confirm the safety and effectiveness of the device.

3. GMP Inspection (if applicable):

   • If the manufacturer is based outside of Indonesia, BPOM may require a GMP inspection or may accept GMP certification from other recognized health authorities (e.g., FDA, EMA, TGA).
   • The GMP inspection ensures that the manufacturing facility follows proper Good Manufacturing Practices.

4. Additional Information:

   • BPOM may request additional documents or information during the review process. Respond to any requests in a timely manner to avoid delays.

6. Issuance of Marketing Authorization (NOM)

Once BPOM has completed the review and is satisfied with the application, they will issue the Marketing Authorization (NOM) and a Registration Certificate for the device.

• Marketing Authorization (NOM): This is the official approval from BPOM allowing the device to be sold and distributed in Indonesia.
• Registration Certificate: This document confirms that the device is officially registered with BPOM.

Upon receiving the NOM and registration certificate, the medical device can legally be marketed in Indonesia.

7. Post-Market Surveillance and Ongoing Compliance

After the device is registered, ongoing responsibilities include:

• Post-Market Surveillance: Monitoring the device’s performance on the market to ensure it continues to meet safety standards.
• Adverse Event Reporting: If any adverse events or safety issues arise, the manufacturer must report these incidents to BPOM.
• Periodic Reporting: Manufacturers must submit periodic reports to BPOM, detailing the device’s performance, complaints, and corrective actions (if applicable).
• Device Recalls: If any safety issues arise that warrant a recall, BPOM may require a recall of the device from the market.

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