Process and Steps for D-Class Medical Device Registration in Indonesia (MOH)

The registration of a D-class medical device (low-risk medical device) in Indonesia is regulated by the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM). The process is relatively straightforward compared to higher-risk classes, but it still requires careful attention to compliance with Indonesian regulatory standards.

Here’s an overview of the steps involved in the D-class medical device registration process:

1. Appoint a Local Authorized Representative

• Requirement: A local authorized representative or distributor in Indonesia is required to handle the registration process on behalf of the manufacturer.
• Role of Local Representative: The local representative will submit the application, communicate with BPOM, and ensure compliance with Indonesian regulations. The representative will also manage post-market surveillance and reporting for adverse events.
• Legal Entity: This entity must be a registered company in Indonesia that is authorized to handle medical device registrations.

2. Ensure Compliance with Indonesian Regulatory Requirements

• Classification of Device: Confirm that the device is classified as D-class according to Indonesian regulations, which apply to low-risk medical devices.
• Quality System Compliance: Ensure the manufacturer follows ISO 13485 or other relevant quality management standards, as BPOM may require proof of compliance.
• Device Standards: The device must meet the applicable Indonesian National Standards (SNI) for medical devices, if any.

3. Prepare Required Documentation

The following documents are generally required for D-class medical device registration:

• Certificate of Free Sale (CFS): Issued by the regulatory authority in the country of origin to prove that the device is legally marketed and sold.
• Product Description: A detailed description of the medical device, including the intended use, specifications, and any technical data required.
• Risk Classification Evidence: Documentation that the device is classified as a D-class (low-risk) medical device.
• Quality Management System Documentation: Evidence that the manufacturer follows international quality management standards like ISO 13485 or a similar recognized standard.
• Device Labeling and Instructions for Use (IFU): Labels and packaging must comply with Indonesian language requirements. The instructions for use must be clear and in Indonesian.
• Importation and Distribution Details: Documentation related to the local distributor or representative, including their credentials to distribute medical devices in Indonesia.

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

• Platform: The registration process is done electronically through the e-Registration system provided by BPOM. The local representative must submit the required documentation via this portal.
• Documents Submission: Upload the necessary documents, including the product description, CFS, labeling, and quality system certification.
• Fee Payment: Pay the registration fee, if applicable, through the portal. The fee structure will depend on the classification of the device and the type of registration.
• Application Form: Complete the online application form, which includes detailed information about the device, manufacturer, and the authorized representative in Indonesia.

5. Review and Evaluation by BPOM

• Initial Review: BPOM will review the submitted documents for completeness and compliance with Indonesian medical device regulations.
• Evaluation Process: BPOM will assess the safety, quality, and performance data for the medical device to ensure it meets the necessary regulatory requirements. For D-class devices, the review process is generally simpler and quicker compared to higher-risk devices.
• Feedback: If any additional information or clarification is required, BPOM will request it from the local representative.

6. Issuance of Registration Certificate

• Approval Notification: Once BPOM has reviewed and approved the application, they will issue a Certificate of Registration for the device.
• Regulatory Approval: This certificate allows the device to be marketed and sold in Indonesia. The registration is typically valid for 5 years and must be renewed after that period.
• Regulatory Number: The device will be assigned a registration number that must be included in all product labeling and promotional materials.

7. Post-Market Surveillance and Compliance

• Market Surveillance: After the device is registered and distributed, the local representative must comply with Indonesian post-market surveillance requirements. This involves monitoring the performance of the device in the market and reporting any adverse events or issues related to product safety or efficacy.
• Annual Reports: BPOM may require periodic reports about the performance of the medical device, including any complaints or incidents related to the device.
• Quality Control: Ongoing quality control is essential to maintain regulatory compliance. The Indonesian authorities may conduct random inspections of products and facilities.

Key Requirements and Considerations:

• Language Requirements: All documents submitted for registration must be in Indonesian or accompanied by certified translations into Indonesian.
• Registration Validity: The registration certificate is typically valid for 5 years, after which it must be renewed.
• Device Labeling: Labels must include specific information in Indonesian, including the product name, manufacturer’s details, instructions for use, and any safety warnings.
• Local Representation: A local authorized representative or distributor is a legal requirement for registration. This entity must be established in Indonesia and registered with the relevant authorities.

Timeline:

• The registration process for a D-class medical device is generally faster compared to higher-risk devices, but the timeline can vary. On average, the process can take anywhere from 2 to 6 months depending on the complexity of the device and the completeness of the application.

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