Registering a Class II medical device with the Indonesian Ministry of Health (MOH), specifically through the National Agency of Drug and Food Control (BPOM), involves a well-defined process, including specific documentation, fees, and regulatory steps. Below are the steps, necessary materials, and precautions for successfully registering a Class II medical device in Indonesia.

Steps for Registering Class II Medical Devices with Indonesia MOH

Step 1: Determine Device Classification

• Class II Classification: Ensure your device is correctly classified as Class II under Indonesian regulations. BPOM categorizes medical devices based on risk, and Class II devices are considered moderate-risk. These devices usually include items like diagnostic tools, certain surgical instruments, and certain patient monitoring systems.

  • If unsure about the classification, consult BPOM guidelines or a local regulatory expert.

Step 2: Appoint a Local Authorized Representative (AR)

• Required for Foreign Manufacturers: If you are a foreign manufacturer, you must appoint a local authorized representative (AR) or an importer in Indonesia. This entity will handle the submission of the registration application to BPOM, manage communication, and be your point of contact.
• The AR must be registered with BPOM and familiar with the registration process.

Step 3: Prepare Required Documentation

Collect and prepare the following documents to submit with your registration application:

1. Cover Letter: A formal letter from the manufacturer or AR indicating the intention to register the device.

2. Product Description: A detailed description of the medical device, including its intended use, model variations (if any), technical specifications, and features.

3. Certificate of Free Sale (CFS): A certificate from the country of origin that proves the device is legally sold in that country. This document is crucial for international recognition of your product.

4. Manufacturing License: If the device is manufactured outside Indonesia, a manufacturing license (from the country of origin) may be required, certifying that the manufacturer complies with regulatory standards.

5. ISO 13485 Certificate: Proof that the manufacturer follows ISO 13485, an international standard for medical device quality management systems. This is required for ensuring product quality and regulatory compliance.

6. Clinical Evaluation Report (CER): If applicable, a clinical evaluation report demonstrating the device's safety and efficacy. This is required for high-risk devices or new products that lack substantial market history.

7. Risk Management Report: Documentation showing that the device complies with ISO 14971, which outlines how risks are identified, assessed, and mitigated during its lifecycle.

8. Labeling: Product labeling and Instructions for Use (IFU) in Bahasa Indonesia. This includes all necessary warnings, instructions, and product details in the local language.

9. Regulatory Application Form: BPOM’s official form filled out with detailed information about the device and the manufacturer. This form can be submitted through BPOM’s e-registration system or manually.

10. Additional Documents (if necessary):

    • CE Marking or other certifications (if available) for further proof of product compliance.
    • Samples for testing or clinical trials, if requested by BPOM.

Step 4: Submit Application to BPOM

• E-registration System: Log into BPOM’s e-registration system for medical devices. This system allows you to submit the necessary documents electronically. You will need to create an account on BPOM’s online portal:
  • BPOM Website: www.pom.go.id
  • Alternatively, you can also submit the application manually if required by BPOM.
• Payment of Fees: Pay any registration fees associated with the process. These fees typically range from IDR 5,000,000 to IDR 15,000,000 (approximately USD 300 to USD 1,000), depending on the device and the complexity of the application.

Step 5: BPOM Review

• BPOM will review the application and all submitted documents to ensure compliance with Indonesian medical device regulations. This review typically takes 1 to 3 months, depending on the workload and complexity of the application.

• During this time, BPOM may request additional information or documentation if necessary. They may also ask for clarifications regarding the product labeling, clinical data, or manufacturing process.

Step 6: Factory Inspection (If Required)

• Inspection: BPOM may request a factory inspection to verify compliance with Good Manufacturing Practices (GMP) and ensure the quality of the manufacturing process.

• This inspection may take 2 to 4 weeks to schedule, depending on the manufacturer’s location and BPOM’s inspection schedule.

Step 7: Registration Certificate Issuance

• If the application is approved and all regulatory requirements are met, BPOM will issue the Registration Certificate (Surat Tanda Pendaftaran, STP). This certificate allows the device to be marketed and sold in Indonesia.

• The registration certificate is typically valid for 5 years. Renewal is required for continued market access.

Step 8: Post-Market Surveillance

• After registration, manufacturers and ARs are required to comply with post-market surveillance requirements, including reporting any adverse events, complaints, or product-related incidents.

• You must also notify BPOM of any changes to the device (e.g., changes in design, labeling, or intended use).

Necessary Materials for Registration

• Product Details: Detailed description and specifications of the device.
• Certificates: CFS, ISO 13485, GMP, etc.
• Risk Management: Report in accordance with ISO 14971.
• Clinical Data: Clinical evaluation or performance data (if applicable).
• Translation: Product labeling and IFUs in Bahasa Indonesia.
• Application Forms: BPOM’s registration forms filled out correctly.

Precautions to Ensure a Smooth Registration Process

1. Accurate Documentation: Ensure that all submitted documents are accurate, complete, and in the required format. Incomplete or incorrect submissions can delay the process.

2. Bahasa Indonesia Translation: All documents, particularly product labels, and instructions for use, must be translated into Bahasa Indonesia. Incorrect or incomplete translations may result in rejection of the application.

3. Regulatory Consultant: If you are unsure about the process or language requirements, consider engaging a local regulatory consultant or working with an experienced importer who understands BPOM’s requirements.

4. Follow-up: Be prepared for potential requests from BPOM for additional information or clarification. Regular follow-up and communication with BPOM or your AR will help expedite the process.

5. Manufacturing Site Inspection: If you’re a foreign manufacturer, be ready for a potential factory inspection. Ensure that your manufacturing processes are compliant with Good Manufacturing Practices (GMP) and that all facilities meet regulatory standards.

6. Cost Consideration: Prepare for registration fees, translation costs, and any potential consultancy or inspection fees. Plan your budget accordingly to avoid delays due to financial constraints.

7. Market Surveillance: After registration, ensure you comply with post-market surveillance regulations, including timely reporting of adverse events and ensuring continued product safety in the market.

By following these steps, ensuring you have the correct documentation, and working with a reliable local representative, you can successfully register your Class II medical device with BPOM in Indonesia. Would you like assistance with any specific step or document preparation?

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