To apply for Class I medical device registration with the Indonesia Ministry of Health (MOH), you must meet specific requirements related to the device, the manufacturer, and the application process. Below are the key requirements for applying for Class I medical device registration in Indonesia:

1. Classification of the Medical Device

• Class I devices are considered low-risk medical devices that do not require clinical trials but must meet safety, performance, and labeling standards.
• Common examples include non-invasive devices like thermometers, bandages, and stethoscopes.
• It’s important to confirm that the device falls under Class I, as higher-risk devices (Class II or III) require more extensive documentation and processes.

2. Local Authorized Representative (AR)

• If you are a foreign manufacturer, you are required to appoint a local authorized representative (AR) in Indonesia.
• The AR must be a legal entity in Indonesia (usually a company) that is authorized by the manufacturer to handle the registration and other regulatory processes.
• The AR acts as the official point of contact with the National Agency of Drug and Food Control (BPOM) and is responsible for ensuring compliance with Indonesian regulations.

3. Documentation Requirements

The following documents are required to complete the registration process for Class I devices:

a. Manufacturer’s Information

• Company registration documents of the manufacturer, such as a business license or certificate proving the manufacturer is legally registered.
• GMP (Good Manufacturing Practice) or ISO 13485 certification (or similar standards) from the manufacturer, demonstrating that the manufacturing process meets international quality standards.

b. Product Information

• Product description: Detailed information about the medical device, including its intended use, functionality, and design.
• Technical specifications: The technical characteristics of the device, including any relevant performance data.
• Risk classification: A statement or documentation confirming the device is classified as Class I according to Indonesian regulations.

c. Certificate of Free Sale (CFS)

• A Certificate of Free Sale (CFS) is issued by the regulatory authority in the country of origin (or any country where the device is legally marketed). This document certifies that the device is freely sold and available on the market in that country.
• The CFS should include product details and market approval status.

d. Labeling

• Product labeling: The labeling (including instructions for use, packaging, and warnings) must be in Bahasa Indonesia and comply with BPOM’s guidelines.
• The label should include details such as the manufacturer’s name and address, device intended use, warnings, instructions, batch numbers, and expiration dates (if applicable).
• Packaging information: Details about the packaging of the device, especially if the product is to be imported into Indonesia.

e. Test Reports (if applicable)

• Depending on the device, you may need to provide test reports demonstrating compliance with relevant safety and performance standards. These can include:
  • Electrical safety standards (for devices like diagnostic equipment)
  • Biocompatibility tests (for devices that come into contact with the body)
  • International standards (e.g., IEC, ISO)
• Quality control documentation and other safety data may also be required for certain devices.

f. Manufacturing Process Documentation

• If required, submit documentation demonstrating that the device is manufactured according to international standards and that it complies with Good Manufacturing Practice (GMP).

4. Application via the e-RD System

• The registration application for Class I medical devices is submitted electronically via the e-RD system.
• The local authorized representative must log into the e-RD system, complete the registration application form, and upload all the necessary documents.
• You will need to create an account on the e-RD system if you do not already have one.

5. Regulatory Review by BPOM

• After submission, the Badan Pengawas Obat dan Makanan (BPOM) will evaluate the application.
• BPOM will review the product for:
  • Compliance with safety and performance requirements.
  • Labeling requirements.
  • Manufacturing compliance.
  • Documentation completeness.
• For Class I devices, BPOM usually performs a relatively quick review compared to higher-risk devices, but it may still take a few weeks.

6. Issuance of Registration Certificate

• Once the application is approved, BPOM will issue a registration certificate for the Class I device.
• The registration certificate is typically valid for 5 years, after which it must be renewed.

7. Post-Market Surveillance

• Even after the device is registered, it must comply with Indonesian post-market surveillance requirements.
• This includes reporting adverse events, complaints, or issues related to the device.
• The local authorized representative is responsible for maintaining compliance with these ongoing regulatory requirements.

Summary of Key Requirements

1. Local Authorized Representative (if foreign manufacturer).
2. Manufacturer Documentation (business license, GMP/ISO certificates).
3. Product Documentation (description, specifications, risk classification).
4. Certificate of Free Sale (CFS) from the country of origin.
5. Product Labeling in Bahasa Indonesia.
6. Test Reports/Quality Documents (depending on the device).
7. Submission through e-RD system for registration.
8. Review and approval by BPOM.
9. Post-market surveillance for compliance.

Costs and Timeline

• Timeline: Registration for Class I devices typically takes 1-3 months, depending on the completeness of the application and BPOM’s review time.
• Costs: The registration fees for Class I devices are generally lower than those for higher-risk devices. The exact cost depends on the device and administrative requirements.

By meeting these requirements and following the necessary steps, you can successfully complete the Class I medical device registration process in Indonesia.

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