Class I medical device registration with the Indonesia Ministry of Health (MOH) refers to the process of obtaining official approval for medical devices classified as low-risk in accordance with Indonesian regulations. Class I medical devices are generally considered to pose minimal risk to patients or users, such as basic tools or equipment like thermometers, bandages, and certain diagnostic devices.

Key Points about Class I Medical Device Registration with Indonesia MOH

1. Class I Device Definition:

   • Class I devices are those with minimal risk when used correctly. They do not require clinical testing but must meet basic safety and performance standards.
   • Examples of Class I devices include non-invasive devices like bandages, gloves, and thermometers.
   • The registration process for Class I devices is relatively simple compared to higher-risk classes.

2. Legal Framework:

   • The registration process is governed by the Indonesian Ministry of Health (MOH), specifically by the National Agency of Drug and Food Control (BPOM), which regulates the safety and quality of medical devices in Indonesia.
   • BPOM enforces the registration process under the Regulation of the Minister of Health No. 62/2017 regarding Medical Device Registration and Distribution.

3. Local Representation Requirement:

   • Foreign manufacturers must appoint a local authorized representative (AR) in Indonesia to handle the registration process. This is a requirement if the manufacturer is not located in Indonesia.
   • The local representative is responsible for ensuring that the registration complies with local regulations and managing communication with the MOH.

How to Apply for Class I Medical Device Registration

1. Determine the Device Classification:

   • Verify that your device is indeed classified as Class I based on risk. Class I devices are typically low-risk, but confirmation is crucial as the registration process differs for higher-risk categories.

2. Designate a Local Authorized Representative (AR):

   • If you are a foreign manufacturer, you must appoint a local Indonesian company as your AR. The AR will act as the intermediary between the manufacturer and the Indonesian authorities.
   • The AR should be licensed to distribute medical devices in Indonesia and should have experience in handling regulatory requirements.

3. Prepare Required Documentation: You will need to gather several key documents for the application, including:

   • Manufacturer’s details: Information about the manufacturing company, including registration and certification (e.g., ISO 13485, GMP certification).
   • Product documentation: A clear description of the product, its intended use, technical specifications, and risk classification.
   • Certificate of Free Sale (CFS): A document issued by the competent authority in the country of origin that confirms the product is approved for sale in that market.
   • Product labeling: Labels must be translated into Bahasa Indonesia and meet local requirements.
   • Test reports: Any relevant safety and performance test reports or evidence that the device complies with international standards.
   • Packaging information: Product packaging details, especially if the device is imported.

4. Submit the Registration Application via e-RD:

   • The registration process is done through the e-RD (electronic registration) system provided by BPOM.
   • Your local authorized representative must log into the e-RD system, fill out the application form, and upload all necessary documents.

5. Assessment by BPOM:

   • BPOM will review the submitted application and documents. The review will include ensuring that the device complies with safety and labeling requirements.
   • For Class I devices, the review process is typically quicker than for higher-risk devices, but it still may take several weeks to months.

6. Approval and Issuance of Registration Certificate:

   • Once BPOM approves the registration, they will issue an official registration certificate for your device.
   • The registration certificate is valid for 5 years. After 5 years, the device must be renewed.

7. Post-Market Surveillance and Compliance:

   • Once registered, the device must comply with Indonesia’s post-market surveillance and adverse event reporting requirements.
   • The local authorized representative is also responsible for ensuring that the device is safe and effective during its time on the market.

Timeline and Costs

• Timeline: The process can take between 1 to 3 months, depending on the completeness of your application and BPOM’s review time.
• Costs: The registration fee varies based on the device category and complexity, but Class I devices typically have lower registration fees compared to higher-risk devices.

Additional Considerations

• Ensure that the local representative understands the regulatory landscape and can handle any follow-up questions or inspections from BPOM.
• It’s essential that your labeling complies with Indonesian language and cultural preferences, as all product labels must be in Bahasa Indonesia.

If you need assistance with any specific part of the process or have further questions about registration for Class I devices, feel free to ask!

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