You can apply for Class I medical device registration with the Indonesia Ministry of Health (MOH) through the e-RD (electronic Registration) system, which is the official online platform for medical device registration in Indonesia.

Steps to Apply through the e-RD System:

1. Create an Account on e-RD Portal:

   • To begin, your local authorized representative (AR) in Indonesia must create an account on the e-RD system. The e-RD system is provided by the Indonesian National Agency of Drug and Food Control (BPOM), which is responsible for regulating medical devices in Indonesia.
   • The AR is typically a licensed company in Indonesia that will manage the application on behalf of the foreign manufacturer.

2. Access the e-RD System:

   • The e-RD system can be accessed at the official BPOM website:
     BPOM e-RD Portal
   • Once logged into the system, the AR will be able to complete the registration form, upload the required documents, and track the status of the application.

3. Complete the Online Application:

   • The local representative will need to fill out the online application form, which includes providing detailed information about the medical device, its manufacturer, and intended use.
   • The AR will also need to upload all required documents, including:
     • Manufacturer information (e.g., ISO certifications, GMP certificates)
     • Product information (e.g., product description, technical specifications)
     • Certificate of Free Sale (CFS) from the country of origin
     • Labeling and packaging information (in Bahasa Indonesia)
     • Safety and performance test reports (if applicable)

4. Document Submission:

   • After filling out the form and uploading the documents, the application is submitted to BPOM for review.

5. Application Review by BPOM:

   • BPOM will evaluate the submitted application. For Class I devices, the review process is usually quicker, but it still depends on the completeness of the application and BPOM's workload.

6. Receive Registration Certificate:

   • Once BPOM approves the application, the registration certificate will be issued for the Class I medical device. This certificate is typically valid for 5 years, after which it must be renewed.

Key Information About the e-RD Portal:

• The e-RD system is the official platform for registering medical devices in Indonesia. It ensures that the entire registration process is done digitally and helps streamline the application process.
• The local authorized representative is responsible for handling the registration process and ensuring that the application meets all regulatory requirements.

Important Note:

• As a foreign manufacturer, you cannot apply directly on the e-RD system. The registration process must be handled by a local authorized representative in Indonesia.
• Ensure that all documents, including product labels and instructions for use, are translated into Bahasa Indonesia to comply with local regulations.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn