The process for D-class medical device registration in Indonesia, regulated by the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control), involves several steps that ensure compliance with local safety, efficacy, and quality standards. D-class medical devices are considered low-risk devices and typically follow a streamlined process compared to higher-risk devices.

Here is an overview of the registration process for D-class medical devices:

Step 1: Pre-Application Preparations

Before beginning the registration process, ensure that the following pre-requisites are in place:

• Product Classification: Confirm that your device qualifies as D-class (low-risk) under the Indonesian classification system.
• Local Representative: If you are a foreign manufacturer, you need a registered local distributor or authorized representative to handle the registration and importation of the device.
• Quality Management System (QMS): Ensure compliance with ISO 13485 or other relevant QMS standards, although it may not be mandatory for D-class devices, it may be helpful.
• Device Documentation: Prepare the necessary technical and safety documents, including performance data, test reports, and labeling information. These documents should meet the local BPOM requirements.

Step 2: Submit Registration Application to BPOM

• Create an Account on e-Registration System: Go to the BPOM's official e-registration system to create an account if you do not already have one. This online portal will be used to submit all documents for registration.
• Submit Application: Log in to the system and submit the application for D-class medical device registration. You will need to provide the following information:
  • Product details (device name, model, manufacturer, intended use).
  • Classification (confirm that the device is D-class).
  • Device description (technical specifications, functions).
  • Manufacturing site information (for foreign manufacturers).
  • Declaration of Conformity (confirm that the device complies with applicable standards).

Step 3: Prepare and Submit Required Documentation

The following documents must be submitted for D-class medical device registration:

1. Product Technical File:

   • Device description (design, functionality, and intended use).
   • Risk analysis (a basic risk assessment showing that the device does not pose significant risks).
   • Test reports (including performance, safety, and biocompatibility testing where applicable).

2. Manufacturing and Quality Documents:

   • Certificate of Free Sale (CFS) from the country of manufacture or other relevant export certificates.
   • ISO 13485 certificate (if applicable), although not always mandatory for D-class devices.
   • Declaration of Conformity (proving the device complies with Indonesian or international standards).

3. Labeling Documents:

   • Indonesian-language labels: The labels must meet the regulatory requirements for medical devices in Indonesia, including product name, manufacturer, and usage instructions.
   • Instructions for Use (IFU): The IFU must be provided in Indonesian, including safety warnings and the device’s intended purpose.

4. Registration Form:

   • Complete the BPOM-provided registration form with all the necessary information about the device and the manufacturer.

Step 4: BPOM Review and Evaluation

Once BPOM receives your application, they will evaluate the submitted documentation. The evaluation includes the following:

1. Completeness Check: BPOM will ensure that all the required documents and information are provided. If anything is missing or unclear, you will be asked to submit additional information.

2. Technical Evaluation: BPOM will review the technical and safety aspects of the device, including performance data, clinical evaluation (if applicable), and conformity with standards.

   • For D-class devices, the technical evaluation process is generally quicker than for higher-risk devices.

3. Labeling Compliance: BPOM will check if the device's labels and packaging are compliant with local regulations (e.g., in Indonesian and meeting specific health and safety standards).

4. Post-market Surveillance Requirements: BPOM may review your post-market surveillance plan and requirements for reporting adverse events or device failures.

Step 5: Issuance of Registration Certificate

If your application is approved, BPOM will issue a registration certificate for the device. This certificate is proof that the device has been approved for sale in Indonesia and meets local regulatory requirements.

• The certificate will include the product name, registration number, and other relevant details.

Step 6: Importation and Distribution

After receiving the registration certificate, the device can be legally imported into Indonesia. The following steps must be taken:

1. Importation: Devices must be imported by a registered local distributor or authorized representative.

   • The distributor must submit import documentation to BPOM, including a copy of the registration certificate.

2. Distribution: The device can be marketed and distributed in Indonesia, following BPOM guidelines on advertising and sales.

3. Post-Market Surveillance: Once the device is on the market, the manufacturer or distributor must monitor its performance and report any adverse events to BPOM, as required under the post-market surveillance regulations.

Step 7: Renewal of Registration

The registration for D-class medical devices is typically valid for 5 years. To continue selling the device in Indonesia after this period, you must apply for renewal:

• Submit updated documentation (e.g., performance reports, post-market surveillance data).
• Renew the registration through the e-Registration system before the expiration date to avoid disruptions in sales.

Key Considerations for D-Class Registration:

• Simplified Process for Low-Risk Devices: Since D-class devices are low-risk, the registration process is generally simplified compared to higher-risk devices.
• Shorter Timeline: Registration for D-class devices can be processed relatively quickly (typically within 3 to 6 months), assuming all documents are correct and complete.
• Local Representation: Foreign manufacturers must have a local distributor or authorized representative in Indonesia for the registration and importation process.

Summary of Steps:

1. Prepare all necessary documents (product details, safety and performance data, labeling).
2. Submit application via BPOM’s e-Registration system.
3. BPOM reviews and evaluates submitted documents.
4. Receive Registration Certificate if approved.
5. Import and Distribute the device through a local distributor.
6. Maintain post-market surveillance and report adverse events if needed.
7. Renew registration after 5 years to continue marketing the device.

This is a general guide to the registration process for D-class medical devices in Indonesia. Ensure that all documentation is complete and in compliance with the latest BPOM regulations to avoid delays or rejections.

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