What is the registration process and steps for Class II medical devices in Indonesia MOH?

The registration process for Class II medical devices in Indonesia is governed by the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control). This process ensures that medical devices placed on the Indonesian market are safe, effective, and comply with local regulations. Below is an overview of the registration process and steps for Class II medical devices.

Step 1: Preliminary Assessment

Before starting the registration process, manufacturers must assess the medical device’s classification and ensure it complies with the Indonesian regulations.

Device Classification: Class II medical devices are those with a moderate level of risk, which typically require more documentation and regulatory scrutiny compared to Class I devices. Class II devices include items like diagnostic equipment, surgical instruments, and dental devices.
Local Authorized Representative: If the manufacturer is not based in Indonesia, an authorized representative in Indonesia must be designated to handle the registration process. The authorized representative must be a registered entity with BPOM and must submit the registration on behalf of the manufacturer.

Step 2: Prepare Necessary Documentation

To initiate the registration process, you must prepare a set of required documents. These documents must be complete and in line with BPOM’s requirements.

Required Documents for Class II Medical Device Registration

Application Form: Complete the BPOM medical device registration application form, available on BPOM’s online portal.
Certificate of Free Sale (CFS): A document issued by the regulatory authority in the country of origin, certifying that the device is legally sold in the country and is compliant with its regulations.
Product Specifications: Detailed specifications of the medical device, including technical details, intended use, and performance characteristics.
ISO 13485 Certification: A copy of the ISO 13485 certification for the manufacturing process, which is mandatory for medical device manufacturers.
Risk Management Documentation: Documents demonstrating that the device has undergone risk management processes, such as a Risk Analysis report (ISO 14971).
Clinical Evaluation Report: If required, a report summarizing the clinical evaluation of the device and its clinical data. This is especially necessary if the device has a high-risk profile or involves new technologies.
Device Labeling: Labels in Bahasa Indonesia and English, including the product’s name, description, intended use, and any warnings or contraindications.
Instructions for Use (IFU): A translated version of the device's instructions for use in Bahasa Indonesia.
Manufacturing Information: Documents detailing the manufacturing processes and any GMP (Good Manufacturing Practice) certifications.
Declaration of Conformity: A statement from the manufacturer that the device meets the necessary standards and is compliant with local regulations (e.g., ISO 13485, GMP).

Step 3: Submit Registration Application

Once all necessary documents have been prepared, the registration application is submitted to BPOM through their e-registration system or e-licensing portal (depending on BPOM's current system). The following key points must be considered:

Submission via e-Registration System

Create a BPOM Account: If you don't already have one, create an account on BPOM's online platform to initiate the registration.
Submit the Application: Upload the prepared documents, such as the product specifications, CFS, clinical data, and ISO certificates, to BPOM's online portal.
Pay Registration Fees: BPOM will assess a registration fee based on the class of the device and the type of device being registered. Ensure the payment is completed as part of the submission.
Document Review: BPOM will conduct an initial review of the submitted documents to ensure they are complete and meet all requirements.

Step 4: Evaluation by BPOM

Once the documents are submitted, BPOM will begin the evaluation process. This process includes:

Document Review: BPOM checks the submitted documents for completeness and correctness.
Technical Evaluation: BPOM may evaluate the technical specifications, clinical data, and safety information for compliance with regulatory standards.
Risk Assessment: BPOM may assess the risk level of the device and the manufacturer’s risk management plan (ISO 14971).
Additional Information: If BPOM requires more information or documentation, they will notify the applicant. Ensure timely response to avoid delays.

Step 5: Inspection (if required)

For Class II medical devices, BPOM may require an inspection of the manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP). This typically applies to devices with more complex manufacturing processes or higher risks.

Inspection: If requested, BPOM will inspect the manufacturing site for compliance with GMP and other regulatory standards.
GMP Certification: The manufacturing facility must hold a valid GMP certificate issued by the relevant regulatory body, which must be submitted as part of the registration application.

Step 6: Post-Market Surveillance Plan

BPOM may require you to submit a post-market surveillance (PMS) plan. This plan outlines how you will monitor the device’s performance in the market after it has been approved and released.

PMS Plan: The PMS plan should include how adverse events, complaints, and device performance will be tracked and reported to BPOM.
Adverse Event Reporting: Ensure a system is in place to promptly report any adverse events or product defects to BPOM.

Step 7: Approval and Issuance of Registration Certificate

If BPOM is satisfied with the documentation, evaluation, and inspections (if applicable), they will approve the registration and issue the Registration Certificate for the medical device.

Certificate Issuance: BPOM will issue a registration certificate for the Class II device, which allows it to be marketed and sold in Indonesia.
Product Listing: The device will be listed in BPOM’s database, confirming its legal status for sale in the Indonesian market.

Step 8: Post-Approval Requirements

After receiving approval, the manufacturer or authorized representative must comply with several ongoing requirements to maintain the device’s registration:

a. Post-Market Surveillance (PMS)

Report Adverse Events: Manufacturers must monitor the device for safety and efficacy and report any adverse events or device-related issues to BPOM.
Renewal: Registration needs to be renewed every 5 years. Ensure that the renewal application is submitted in advance (typically 6 months before expiration).

b. Labeling and IFU Updates

Ensure that the labeling and Instructions for Use (IFU) comply with local regulations. If any changes are made to the device’s labeling or intended use, BPOM must be notified.

c. GMP Compliance

Continue to comply with Good Manufacturing Practices (GMP) and provide regular updates or inspections as required by BPOM.

d. Advertising and Promotional Compliance

Ensure that any advertising or promotional materials for the device are accurate and comply with BPOM guidelines. Any new promotional materials must be approved by BPOM before distribution.

Summary of Steps for Class II Medical Device Registration in Indonesia

Preliminary Assessment: Confirm the device classification, appoint an authorized representative (if needed), and review BPOM requirements.
Prepare Documentation: Gather required documents such as the application form, CFS, product specifications, ISO certifications, clinical data, and labeling.
Submit Registration Application: Submit the application and supporting documents via BPOM's online portal and pay the necessary fees.
Evaluation by BPOM: BPOM reviews the submitted documents, evaluates safety and performance data, and may conduct additional assessments.
Inspection (if applicable): BPOM may inspect the manufacturing site to verify GMP compliance.
Post-Market Surveillance Plan: Submit a post-market surveillance plan to monitor the device’s performance in the market.
Approval and Issuance of Registration Certificate: If the application is successful, BPOM issues the registration certificate, allowing market access.
Post-Approval Requirements: Maintain post-market surveillance, renew the registration after 5 years, and ensure ongoing compliance with BPOM regulations.

By following these steps, you can successfully navigate the process of registering a Class II medical device with the Indonesian MOH and BPOM. Let me know if you'd like more details on any specific step or document requirements!