Requirements for D-Class Medical Device Registration in Indonesia (MOH)

In Indonesia, the registration of medical devices is regulated by the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM). Medical devices are classified into four classes (A, B, C, and D) based on their risk level. D-class devices are considered low-risk devices and are subject to less stringent regulatory requirements compared to higher-risk devices. However, the registration process still requires the submission of various documents and compliance with Indonesian standards.

Here are the key requirements for registering a D-class medical device in Indonesia:

1. Appoint a Local Authorized Representative or Distributor

• Local Representation: You must appoint a local authorized representative or distributor in Indonesia to handle the registration process. This entity will act as a liaison between the manufacturer and BPOM.
• Legal Requirement: A local representative is necessary for all foreign manufacturers, and the device cannot be registered without one. The authorized representative is responsible for submitting documents, ensuring regulatory compliance, and managing post-market surveillance.

2. Device Classification as D-Class

• Risk Classification: The device must be classified as D-class, which refers to low-risk medical devices. BPOM follows a classification system that categorizes devices based on their risk to the patient and user. D-class devices typically involve non-invasive procedures or have minimal patient interaction.
• Risk Documentation: The application must include documentation that demonstrates the device is classified as a D-class device under Indonesian medical device regulations.

3. Product Documentation and Information

The following documentation is typically required for D-class medical device registration:

• Certificate of Free Sale (CFS):

  • This document proves that the device is legally marketed in the country of origin or another country where it has regulatory approval.
  • The CFS is issued by the regulatory authority in the country where the device is manufactured and is necessary for the registration process.

• Product Description and Intended Use:

  • A comprehensive description of the device, including its intended use, technological features, and how it works.
  • The product description should clearly state that it falls under the D-class category (low-risk) in terms of its intended purpose.

• Labeling and Instructions for Use (IFU):

  • All product labels, packaging, and instructions for use must comply with Indonesian regulations.
  • Labels should be in Indonesian, and must include product details such as the device name, manufacturer’s information, country of origin, lot/batch number, expiration date (if applicable), and any necessary warnings.
  • Instructions for use must also be in Indonesian and provide clear, understandable directions for safe use.

• Evidence of Compliance with International Standards:

  • Manufacturers may need to demonstrate compliance with quality management standards such as ISO 13485 or other recognized quality control standards.
  • This may include submitting evidence that the device is manufactured under a certified quality management system.

• Device Risk Classification Documentation:

  • Provide documentation or a self-declaration that the device is classified as D-class, demonstrating that it is low-risk.

4. Quality Management System (QMS) Documentation

• While not always mandatory for low-risk devices, providing evidence of adherence to a quality management system (QMS) such as ISO 13485 can help streamline the registration process and demonstrate the manufacturer's commitment to quality and safety.
• Some low-risk devices may not require full QMS documentation, but it's always advisable to provide this if the device is manufactured in compliance with recognized international standards.

5. Local Importer or Distributor Details

• The local representative or distributor in Indonesia must be registered and authorized to act on behalf of the manufacturer.
• The registration of the local distributor should include:
  • A copy of the Distributor’s Business License (SIUP).
  • A signed agreement between the manufacturer and the local representative.
  • Proof of the distributor’s capability to handle medical device imports and distribution in Indonesia.

6. Submission Through BPOM’s e-Registration System

• Electronic Submission: The application for registration is submitted through the BPOM’s e-Registration system. The local representative will need to upload all required documents through this portal.
• Application Form: The form must be filled out with accurate details of the device, its manufacturer, and the local distributor.
• Registration Fees: A registration fee is typically required and must be paid via the e-Registration system. The amount will vary depending on the type and class of the medical device.

7. Evaluation by BPOM

• Document Review: BPOM will review the submitted documents to ensure compliance with Indonesian medical device regulations.
• Evaluation Criteria: BPOM will evaluate factors such as product safety, efficacy, labeling, quality, and the risk classification.
• Request for Additional Information: If BPOM finds the submission incomplete or unclear, they may request additional documentation or clarification from the local representative.

8. Issuance of Registration Certificate

• Once BPOM has completed the evaluation and found everything in order, they will issue the Certificate of Registration for the device.
• Validity: The registration certificate is typically valid for 5 years and must be renewed before its expiration.

9. Post-Market Surveillance and Compliance

• Ongoing Monitoring: After the device is registered, the local representative must comply with Indonesia’s post-market surveillance requirements. This includes monitoring the device's performance in the market, reporting any adverse events, and ensuring ongoing compliance with regulations.
• Adverse Event Reporting: Any complaints, defects, or safety issues related to the device must be reported to BPOM.

Key Considerations:

• Local Language Requirements: All documents submitted to BPOM (including labeling, instructions for use, and certificates) must be in Indonesian or accompanied by certified translations.
• Local Representation: You cannot directly register a device in Indonesia unless you have a local authorized representative or distributor.
• Device Labeling: All labeling must comply with BPOM’s specific requirements for medical devices, including having product details, warnings, and usage instructions in the Indonesian language.

Timeline for Registration:

• D-class devices generally experience a faster registration process compared to higher-risk classes. The process can take between 2 to 6 months, depending on the completeness of the submission and BPOM’s workload.

Helpful Resources:

• BPOM Website: https://www.pom.go.id
• Indonesian Ministry of Health: https://www.kemkes.go.id

By following these steps and ensuring you meet all the requirements, you can successfully register your D-class medical device in Indonesia and enter the market. It's advisable to work closely with a local regulatory consultant or representative to ensure that the process is completed smoothly and in compliance with Indonesian regulations.

Contact Us：

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