Handling the registration of B-class medical devices in Indonesia with the Ministry of Health (MOH) through the National Agency of Drug and Food Control (BPOM) involves several detailed steps. The registration process can be complex, but with the right preparation and understanding of regulatory requirements, you can successfully navigate the process. Below is a step-by-step guide on how to handle the registration for B-class medical devices in Indonesia:

1. Understand the Regulatory Framework

Before starting the registration process, it’s crucial to familiarize yourself with the relevant Indonesian regulations for medical devices. The primary regulation is BPOM Regulation No. 31 of 2018 on Medical Device Classification, which classifies devices into four categories (A, B, C, and D) based on their risk level. B-class devices are considered moderate-risk devices and are subject to regulatory oversight by BPOM.

2. Confirm the Classification of Your Device

Determine whether your device is correctly classified as B-class. This classification depends on factors such as the intended use of the device, the level of risk to patients, and the degree of invasiveness. B-class devices are typically:

• Devices that pose a moderate risk to patient safety.
• May require clinical data or performance testing to demonstrate safety and efficacy.
• Often non-invasive or minimally invasive.

3. Appoint a Local Authorized Representative

If your company is based outside Indonesia, you must appoint an authorized local representative or distributor who will manage the registration process on your behalf. The authorized representative will submit documents to BPOM, receive communication, and ensure compliance with local regulations. The representative must be a legal entity registered in Indonesia.

4. Prepare the Required Documents

A critical part of the registration process is gathering all required documents. The exact documents required will depend on the device, but typical requirements include:

• Cover Letter: A letter that formally requests registration.
• Device Description: A detailed description of the device, including its intended use, indications, and classification.
• Manufacturer Information: The company name, location, and manufacturing practices. If applicable, provide Good Manufacturing Practice (GMP) certification.
• Certificate of Free Sale (CFS): A document issued by the country of origin that confirms the device is legally sold in that market.
• Clinical Data (if applicable): Clinical trial data or performance testing data showing that the device is safe and effective for its intended use.
• Risk Management Documentation: A risk assessment and management file, demonstrating how risks associated with the device are controlled.
• ISO 13485 Certification: Proof of compliance with ISO 13485, which indicates that the manufacturer follows quality management practices for medical devices.
• Product Testing Reports: Any required testing for biocompatibility, electrical safety, or other relevant standards.
• Labeling and Instructions for Use: Product labels and instructions for use in Bahasa Indonesia (if required) along with the regulatory-required details like warnings and indications.
• Packaging: Information on how the device is packaged and labeled.

Ensure all documents are translated into Bahasa Indonesia where necessary.

5. Register on BPOM’s e-Registration Portal

The e-Registration system is used to submit your application to BPOM. Create an account on BPOM’s online portal: https://ereg.pom.go.id. Follow these steps:

• Create an Account: If you don’t already have an account, create one on the e-Registration system.
• Select the Appropriate Registration Type: Choose the appropriate medical device registration category (B-class) and complete the required forms.
• Upload Required Documents: Submit all the documents mentioned above through the portal.

6. Pay the Registration Fees

BPOM charges registration fees, which are based on the type and risk classification of the device. You will need to make the payment through the BPOM e-Registration system. The fee varies, but you should expect a fee based on the device’s class and application.

7. BPOM’s Review and Evaluation

Once your application is submitted, BPOM will conduct a comprehensive review of the documents. This involves several steps:

• Document Verification: BPOM checks the completeness and accuracy of the submitted documents.
• Technical Evaluation: BPOM assesses the technical file, risk management documents, performance data, and any other relevant information.
• Clinical Data Review: If clinical data is provided, BPOM will evaluate it for safety and efficacy.
• Labeling Review: BPOM checks that your product labeling meets Indonesian requirements, including compliance with Bahasa Indonesia labeling and the necessary regulatory details.
• GMP and Manufacturer Compliance: If applicable, BPOM will verify that the manufacturing facility meets Good Manufacturing Practice (GMP) standards.

This evaluation process typically takes 2 to 4 months, depending on the complexity of the device and whether BPOM needs additional information or testing results.

8. Respond to Queries or Additional Requests

BPOM may request additional information or clarification during the review process. Ensure that you are ready to respond promptly to any requests to avoid delays in the process. It’s essential to be in close contact with your authorized representative to ensure timely submission of any additional documents.

9. Approval and Issuance of Surat Izin Edar (SIE)

If BPOM is satisfied with your application, it will approve the registration, and you will receive a Surat Izin Edar (SIE). The SIE is an official approval document that allows you to legally market and distribute the medical device in Indonesia.

• SIE Validity: The SIE is typically valid for 5 years from the approval date. You will need to apply for renewal before the expiration date if you wish to continue marketing the device in Indonesia.

10. Post-Approval Requirements

Once your device is registered, you must comply with post-market regulations, including:

• Post-market surveillance: Monitor the safety and performance of the device in the market.
• Adverse Event Reporting: Report any adverse events or product defects to BPOM as required.
• Renewal: Apply for renewal of the SIE before it expires (after 5 years).
• Product Updates or Changes: If there are changes to the device (such as design or labeling), you must notify BPOM and may need to submit a modification application.

11. Handling Distributors and Importation

If you are not directly importing the device, your local distributor must handle the importation process. They must ensure the device complies with all Indonesian customs and import regulations, including obtaining an Import Notification from BPOM.

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