To register and apply for B-class medical device registration in Indonesia with the Ministry of Health (MOH), through the National Agency of Drug and Food Control (BPOM), you need to follow a structured process. Below is a detailed guide on the steps and requirements for registering a B-class medical device in Indonesia:

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

Step 1: Confirm the Device Classification

Before starting the registration process, confirm whether your device qualifies as a B-class medical device based on the level of risk it poses. B-class devices are typically moderate-risk devices, which could include:

• Diagnostic devices
• Non-invasive or minimally invasive medical devices
• Devices that might require clinical data to demonstrate safety and efficacy.

B-class devices are subject to moderate regulatory oversight in Indonesia. The classification is determined based on the intended use, invasiveness, and the level of risk posed by the device.

Step 2: Appoint a Local Authorized Representative

If the manufacturer of the device is based outside of Indonesia, you must appoint a local authorized representative or distributor in Indonesia. This representative will manage the registration process and act as the point of contact with BPOM.

The local representative must be:

• A legal entity registered in Indonesia.
• Authorized to act on behalf of the foreign manufacturer to submit documents, respond to BPOM queries, and ensure compliance.

Step 3: Gather Required Documents

Prepare all necessary documentation to submit to BPOM for the B-class medical device registration. The required documents typically include:

1. Cover Letter: A formal letter requesting device registration and providing basic information about the device.
2. Certificate of Free Sale (CFS): A certificate issued by the country of origin, confirming that the device is legally sold in the domestic market.
3. Device Description: A detailed description of the device, including its intended use, technology, specifications, and classifications.
4. Manufacturer Information: Manufacturer’s name, address, and relevant regulatory certifications (e.g., Good Manufacturing Practice (GMP)).
5. ISO 13485 Certification: Proof that the manufacturer complies with international standards for medical device quality management.
6. Clinical Data (if applicable): Data from clinical trials or other performance testing to demonstrate safety and effectiveness (only required for certain devices).
7. Risk Management File: Documentation outlining the identification, assessment, and mitigation of risks associated with the device.
8. Testing Reports: Safety and performance testing reports (e.g., electrical safety, biocompatibility, etc.).
9. Product Labeling and Instructions for Use: Samples of the product’s labeling and instructions, translated into Bahasa Indonesia (Indonesian language).

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

BPOM requires all medical device registrations to be submitted via its online e-Registration portal. Follow these steps:

1. Create an Account on BPOM’s Portal: If you don’t already have one, create an account on BPOM’s e-Registration system (https://ereg.pom.go.id).
2. Select the Appropriate Application Type: Choose B-class medical device when filling out the registration application form.
3. Complete the Application Form: Provide the necessary details about your device, such as product name, manufacturer details, intended use, and classification.
4. Upload the Required Documents: Submit all the required documents listed above. Ensure all documents are translated into Bahasa Indonesia (if necessary).
5. Pay the Registration Fee: BPOM charges a fee for device registration, which can be paid through the e-Registration system. The fee is typically based on the device classification and type.

Step 5: BPOM Review and Evaluation

Once your application and documents are submitted, BPOM will review them. The review process includes:

1. Document Verification: BPOM checks whether all documents are complete, accurate, and in compliance with regulations.
2. Technical Evaluation: BPOM evaluates the technical aspects of the device, including the risk management plan, performance data, and clinical data (if applicable).
3. Clinical Data Review: If clinical data is submitted, BPOM reviews it to verify the device’s safety and efficacy.
4. Labeling Review: BPOM ensures that the device’s labeling meets regulatory requirements, including proper instructions for use and risk warnings in Bahasa Indonesia.
5. GMP Compliance: If the device is manufactured outside Indonesia, BPOM will verify whether the manufacturing facility complies with Good Manufacturing Practice (GMP) standards.

The review process typically takes 2 to 4 months but can vary depending on the complexity of the device and the completeness of the application.

Step 6: Response to BPOM Queries

BPOM may request additional information or clarification during the review process. Be prepared to respond quickly to any queries or additional document requests to avoid delays.

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

If BPOM is satisfied with the application, they will issue the Surat Izin Edar (SIE), which is the official approval for marketing and distributing the device in Indonesia.

• The SIE will be valid for 5 years.
• The device can be marketed and distributed in Indonesia only after receiving the SIE.

Step 8: Post-Approval Requirements

After the device is registered, there are several ongoing regulatory requirements to maintain compliance:

1. Post-Market Surveillance: You must monitor the performance of the device once it’s on the market and report any adverse events to BPOM.
2. Adverse Event Reporting: Any product-related adverse events must be reported to BPOM according to local regulations.
3. Renewal: The SIE is valid for 5 years, and you will need to apply for renewal before it expires.
4. Modifications: If there are any changes to the device (e.g., labeling changes, manufacturing process changes), you must inform BPOM and may need to submit a modification application.

Step 9: Market Entry and Distribution

After obtaining the SIE, your device can be distributed in Indonesia. If you are not directly importing the device, your local representative or distributor will manage the importation process, including obtaining any necessary import permits.

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