The process for B-class medical device registration in Indonesia, overseen by the Ministry of Health (MOH) through the National Agency of Drug and Food Control (BPOM), involves several key steps. B-class devices are considered moderate-risk medical devices, and their registration requires detailed documentation to ensure safety and efficacy.

Here is a step-by-step guide for the B-class medical device registration process in Indonesia:

Step 1: Determine the Classification of Your Device

• Confirm Classification: Ensure that your device is appropriately classified as B-class based on the level of risk it poses to patients. B-class devices are typically moderate-risk and may include products that do not significantly affect the patient, but still require regulatory oversight.

• Device Categorization: B-class devices may include diagnostic equipment, certain surgical instruments, or diagnostic reagents, among others. You can check the Indonesian medical device classification rules to determine the classification.

Step 2: Appoint a Local Authorized Representative (for foreign manufacturers)

• If the manufacturer is based outside of Indonesia, it is mandatory to appoint a local authorized representative (distributor or agent) in Indonesia. This representative will handle the registration process on behalf of the manufacturer.

• The local representative must be an Indonesian legal entity registered with BPOM and will be the primary point of contact for all communications with BPOM.

Step 3: Gather Required Documents

Prepare the necessary documentation to submit to BPOM. Required documents typically include:

1. Cover Letter: A formal request for registration addressed to BPOM.
2. Certificate of Free Sale (CFS): A certificate from the country of origin verifying that the medical device is legally sold in that market.
3. Device Description: A comprehensive description of the device, including its intended use, classification, and specifications.
4. Manufacturer Information: Name, address, and contact details of the manufacturer, including any GMP (Good Manufacturing Practice) certifications.
5. ISO 13485 Certificate: Proof that the manufacturer follows international quality management standards.
6. Clinical Data (if applicable): Clinical trial data or other performance data demonstrating the safety and effectiveness of the device.
7. Risk Management File: A document detailing risk analysis and mitigation strategies.
8. Product Labeling: Samples of the product’s labels and instructions for use, including translations into Bahasa Indonesia (Indonesian language).
9. Testing Reports: Reports on product safety and performance, such as biocompatibility, electrical safety, or mechanical testing, depending on the type of device.

Step 4: Submit the Application via BPOM’s e-Registration Portal

• Register on BPOM’s Online System: Create an account on BPOM’s e-Registration portal (e-reg.pom.go.id).

• Fill out the Application Form: Select the appropriate registration type (B-class medical device) and fill out the required forms.

• Upload Documents: Upload all the prepared documents electronically to the portal. This includes the device description, clinical data (if applicable), ISO certifications, and other required documentation.

• Pay Registration Fees: BPOM charges a registration fee for medical devices, and the payment can be made through the e-Registration system. The fee is typically based on the type of device and its classification.

Step 5: BPOM’s Review Process

BPOM will evaluate the submitted application. The review process typically includes the following steps:

1. Document Verification: BPOM will first verify the completeness and accuracy of the submitted documents. Incomplete or incorrect submissions can lead to delays or rejection.

2. Technical Evaluation: BPOM will assess the technical aspects of the device, such as design, performance, and safety. They will also check the risk management documentation to ensure that potential risks associated with the device are well controlled.

3. Clinical Data Review: If applicable, BPOM will review the clinical trial data or performance data submitted for the device. This step ensures that the device is both safe and effective for its intended use.

4. GMP Compliance: If the device is manufactured outside Indonesia, BPOM will check whether the manufacturer complies with Good Manufacturing Practice (GMP). BPOM may require GMP certificates from the manufacturing facility.

5. Labeling Review: BPOM will review the device’s labeling and packaging to ensure it complies with Indonesian regulations, including requirements for the use of Bahasa Indonesia on labels and the inclusion of necessary regulatory information (e.g., risk warnings, indications for use).

Step 6: Response to BPOM Queries (If Required)

• During the review process, BPOM may request additional information, clarification, or even product testing. Ensure that your local representative is prepared to respond promptly to avoid delays.

• Be ready to submit additional documents or make corrections to previously submitted information if BPOM finds any discrepancies.

Step 7: BPOM Approval and Issuance of Surat Izin Edar (SIE)

• Surat Izin Edar (SIE): If BPOM approves the registration, they will issue the Surat Izin Edar (SIE). The SIE is the official authorization that allows the medical device to be marketed and distributed in Indonesia.

• Validity of SIE: The SIE is typically valid for 5 years. Before it expires, you must apply for renewal to continue marketing the device in Indonesia.

Step 8: Post-Approval Compliance and Monitoring

Once the device is approved and registered, you must comply with post-market requirements, including:

1. Post-Market Surveillance: You will need to monitor the device’s performance in the market and report any adverse events to BPOM.

2. Adverse Event Reporting: If any adverse events or product failures occur, you must report them to BPOM in accordance with Indonesian regulations.

3. SIE Renewal: Apply for the renewal of the SIE before it expires (within 5 years). If there are changes to the device (e.g., manufacturing changes, updates to labeling), you may need to submit a modification application.

Step 9: Market Entry

After obtaining the SIE, your device is legally allowed to enter the Indonesian market. You can now proceed with distribution, marketing, and sales within Indonesia. Your authorized representative will handle these operations, ensuring compliance with Indonesian regulations.