The process of registering a Class I medical device with the Indonesia Ministry of Health (MOH) involves several key steps, along with specific documentation requirements and important considerations. Below is a detailed breakdown of the process, documents, and considerations to ensure successful registration.

Process for Class I Medical Device Registration with the Indonesia MOH

1. Appoint a Local Authorized Representative (AR)

• If you are a foreign manufacturer, you are required to appoint a local authorized representative (AR) in Indonesia. The AR is typically a licensed Indonesian company that will act as the liaison between the manufacturer and the Indonesian National Agency of Drug and Food Control (BPOM).
• The AR is responsible for managing the entire registration process, ensuring that the application complies with Indonesian regulations, and handling communication with BPOM.

2. Classify the Medical Device

• Ensure that your medical device is correctly classified as Class I. Class I devices are considered low-risk and usually include non-invasive devices such as bandages, thermometers, and gloves.
• If the device does not fit the Class I classification, it may need to be reclassified, and the registration process will differ for Class II or III devices.

3. Prepare the Required Documents

The application for Class I medical device registration requires several key documents. These documents must be submitted electronically via the e-RD system by the local authorized representative.

Required Documents:

1. Manufacturer Information:

   • Business License: Proof that the manufacturer is legally registered and authorized to produce medical devices.
   • GMP (Good Manufacturing Practice) certificate or ISO 13485 certification (or equivalent standards) to ensure the manufacturer meets international quality standards for production.

2. Device Information:

   • Device Description: A detailed description of the medical device, including its intended use and any technical specifications (e.g., size, material, mode of action).
   • Risk Classification: A document or statement confirming that the device is classified as Class I according to Indonesian regulations.

3. Certificate of Free Sale (CFS):

   • The CFS is a certificate issued by the health regulatory authority in the country of origin, confirming that the device is legally sold in that market.
   • The CFS should include details about the product and market approval status.

4. Labeling:

   • Product Label: All labels must comply with Indonesian requirements and be translated into Bahasa Indonesia.
   • The labeling should include essential information such as the manufacturer’s name, device intended use, safety instructions, and warnings.
   • Packaging Information: Detailed packaging information, especially for imported devices.

5. Test Reports (if applicable):

   • Safety and Performance Test Reports: If the device is subject to specific safety or performance standards (e.g., electrical safety, biocompatibility), you will need to submit relevant test reports from accredited laboratories.
   • International Standards Compliance: If the device meets international standards such as ISO or IEC, provide relevant documentation to demonstrate this compliance.

6. Manufacturing Process Documents:

   • Documentation showing that the device is manufactured according to international standards such as Good Manufacturing Practice (GMP).

4. Submit Application via e-RD System

• The local authorized representative will log into the e-RD system (electronic Registration system) provided by BPOM. The e-RD system is the official platform for submitting medical device registrations in Indonesia.
• The AR will complete the application form, upload all required documents, and submit them electronically.

5. BPOM Evaluation

• BPOM will review the submitted application and ensure that it complies with regulatory standards. For Class I devices, BPOM’s review is generally quicker compared to higher-risk devices, but it still involves checking for:
  • Compliance with safety and performance requirements.
  • Labeling compliance (e.g., proper translations, warnings, and instructions).
  • Document completeness (e.g., GMP certifications, CFS, product description).

Note: BPOM may ask for additional documentation or clarifications during the review process, so be prepared for follow-up requests.

6. Issuance of Registration Certificate

• After BPOM reviews and approves the application, they will issue a registration certificate for the device. The certificate confirms that the device is legally authorized for sale and distribution in Indonesia.
• The registration certificate is typically valid for 5 years. After 5 years, you must submit a renewal application to continue marketing the device in Indonesia.

7. Post-Market Surveillance

• After obtaining registration, you must comply with post-market surveillance requirements, including reporting any adverse events or device-related issues.
• The local authorized representative must ensure that the device continues to meet safety standards throughout its market life.

Important Considerations for Class I Medical Device Registration

1. Language Requirements:

   • All product labeling, user manuals, and other documentation must be translated into Bahasa Indonesia. BPOM will not accept documents in English or other languages unless they are properly translated.

2. Local Authorized Representative:

   • As a foreign manufacturer, you cannot submit the registration directly through the e-RD system. A local AR in Indonesia is required to handle the process on your behalf.
   • The AR must be registered with BPOM and authorized to handle medical device registrations.

3. Device Classification:

   • Confirm the device classification is accurate. Class I devices are low-risk and exempt from clinical trials, but misclassification can lead to delays or complications in the registration process.

4. Labeling Compliance:

   • The product labels must include important information like the manufacturer’s name, the device's intended use, warnings, and instructions, and it must be in Bahasa Indonesia.
   • Ensure that all required label details are properly translated and formatted according to Indonesian regulations.

5. Regulatory Updates:

   • Stay informed about any updates or changes to Indonesian medical device regulations, as regulations may evolve over time, impacting your device's status or registration process.

6. Timely Submission:

   • Make sure that all documentation is complete and accurate before submission. Incomplete or incorrect applications can delay the registration process.

7. Registration Renewal:

   • The registration certificate is valid for 5 years, so be prepared to renew the registration at the end of this period to continue selling the device in Indonesia.

Estimated Timeline and Costs

• Timeline: The registration process for Class I devices typically takes around 1 to 3 months from submission to approval, depending on the completeness of the application and BPOM's review process.
• Costs: The costs for Class I medical device registration are typically lower compared to higher-risk devices. Expect to pay between IDR 1,000,000 to IDR 10,000,000 (approximately USD 65 to USD 650) for the registration, with additional costs for the local authorized representative and other services like document translation and labeling.

By following these steps, preparing the required documentation, and ensuring compliance with regulatory standards, you can successfully register your Class I medical device with the Indonesia Ministry of Health (MOH).

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