To apply for Class I medical device registration with the Indonesia Ministry of Health (MOH), you need to follow these steps:

1. Determine the Classification

• Confirm that your medical device falls under Class I, which are low-risk devices (e.g., bandages, thermometers). Class I devices have a simpler registration process compared to higher-risk classes.

2. Local Representation

• A local Indonesian company must act as your authorized representative (AR) if you are a foreign manufacturer. The AR will handle the registration process on your behalf with the Indonesian Ministry of Health.

3. Prepare Required Documents

You will need to prepare the following documents for registration:

• Company registration documents of the local representative.
• Product labeling (in Bahasa Indonesia).
• Product description and intended use.
• Proof of manufacturing compliance (e.g., ISO certification, GMP, or other relevant certifications).
• Certificate of Free Sale (CFS) or Marketing Authorization from the country of origin or the manufacturer.
• Safety and performance data (if required).

4. Submit Online Application via e-Registration System (e-RD)

• Submit the application through the e-RD system (electronic registration system) provided by the Indonesian Ministry of Health.
• You will need to create an account on the e-RD portal and follow the instructions to submit your registration. The local representative will typically be responsible for this submission.

5. Review and Evaluation by BPOM (Indonesian FDA)

• The BPOM (Badan Pengawas Obat dan Makanan) will review your submission. The evaluation will include a review of the product's safety, labeling, and compliance with Indonesian regulations.
• For Class I devices, the review process is generally quicker, but it may still take several weeks to a couple of months.

6. Approval and Issuance of Registration Certificate

• Once the BPOM approves your application, they will issue a registration certificate for your medical device. This registration is valid for 5 years, after which renewal is required.

7. Post-Market Surveillance

• Once your device is on the market, you will need to comply with Indonesian post-market surveillance regulations, including adverse event reporting and annual product renewals.

8. Importation and Distribution

• After registration, your device can be imported into Indonesia for sale and distribution. Ensure that your distributor complies with local requirements, such as licensing and periodic inspections.

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