The process for B-class medical device registration in Indonesia with the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) involves several critical steps, from initial preparation to the final approval. B-class medical devices are considered medium-risk devices, and the registration process includes submitting comprehensive documentation, undergoing regulatory review, and complying with various requirements.

Here is a detailed breakdown of the process and steps involved:

1. Preliminary Preparation

Before submitting the application for B-class medical device registration, the following preparations should be made:

• Classify the Device: Ensure the device is correctly classified as B-class based on its intended use, risks, and regulatory classification criteria under BPOM Regulation No. 31 of 2018.
• Nominate an Authorized Representative: If the manufacturer is located outside Indonesia, appoint an authorized local representative who will handle the registration process.
• Ensure Compliance: Verify that the device meets all relevant Indonesian regulations and standards, including Good Manufacturing Practices (GMP), ISO certifications (e.g., ISO 13485), and product safety standards.

2. Submit Application for Registration

Once the preparation is complete, the next step is to submit the application for B-class medical device registration.

Steps to Submit the Application:

1. Register on BPOM’s Online System (e-registration):

   • Access the BPOM e-registration portal: https://ereg.pom.go.id.
   • Create an account if you don’t already have one.
   • Select the appropriate type of registration for the medical device.

2. Prepare Required Documents: You will need to submit a comprehensive set of documents that may include:

   • Cover letter for registration.
   • Device description and intended use.
   • Manufacturer’s details (including GMP certification).
   • Certificate of Free Sale or market authorization from the country of origin.
   • Risk management file, including the risk analysis and mitigation measures.
   • Clinical performance and safety data (if applicable).
   • Product testing reports (e.g., biocompatibility, electrical safety, etc.).
   • ISO 13485 certificate or evidence of GMP compliance.
   • Labeling (including Bahasa Indonesia version of the Instructions for Use (IFU), product labels, and packaging).
   • Local distributor authorization (if applicable).

3. Pay Registration Fees: BPOM charges registration fees, which can be paid through the online portal. The fee is generally based on the device type and registration category.

4. Submit Documents via the BPOM System: Once the application form is completed and the documents are gathered, submit the entire application package through BPOM’s online portal.

3. BPOM Review and Evaluation

BPOM will review the application and all submitted documents. This step involves the regulatory agency evaluating the safety, performance, and compliance of the device with Indonesian regulations.

BPOM’s Evaluation Process:

• Document Verification: BPOM will verify the completeness of the documentation and ensure that all required documents are submitted. If any documents are missing or incomplete, BPOM may request additional information.
• Technical Assessment: BPOM evaluates the technical file to verify that the device complies with Indonesian medical device safety and efficacy standards.
• Clinical Data Review: If required, BPOM will assess clinical data to confirm that the device is safe and effective for its intended use.
• Labeling Review: BPOM will review the labeling and instructions for use (IFU) to ensure compliance with Indonesian language and format requirements.

BPOM’s Timeline for Evaluation:

• Standard Processing Time: Typically, BPOM takes about 2-4 months to review and process a B-class medical device registration application, though this can vary depending on the complexity of the device, the completeness of the application, and the volume of applications.

4. Registration Approval

Once BPOM completes the evaluation process and determines that the device meets all regulatory requirements, the Surat Izin Edar (SIE) will be issued.

• Issuance of SIE: The Surat Izin Edar (SIE) is the official document that grants authorization for the device to be marketed and sold in Indonesia. This approval is typically valid for 5 years from the date of issuance.

• Official Notification: BPOM will notify the applicant once the registration is approved. The manufacturer or authorized representative will receive the SIE through the online system.

5. Post-Approval Actions

After receiving the SIE, the following steps should be taken:

Post-Market Requirements:

• Post-Market Surveillance: Implement an ongoing system to monitor the safety and performance of the device once it is in the market. This includes collecting feedback from users and healthcare professionals, tracking adverse events, and reporting them to BPOM.

• Adverse Event Reporting: If any adverse events or safety issues occur, they must be reported to BPOM within the required time frame.

• Product Recalls: If a safety issue is identified, BPOM may require a product recall. The manufacturer or authorized representative must take corrective actions as instructed by BPOM.

• Registration Renewal: The SIE is valid for 5 years. The registration must be renewed before the expiration date by submitting a renewal application along with updated documents, post-market data, and any changes to the device.

• Device Modifications: If there are any changes to the device, such as a modification in design, intended use, or labeling, these must be reported to BPOM, and additional approval may be required.

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