The process for Class A medical device registration with Indonesia's Ministry of Health (MOH) involves several steps to ensure the device meets safety, quality, and regulatory standards. Class A medical devices are considered low-risk devices and have the simplest registration process compared to higher-risk devices (Class B, C, or D). Below is a detailed step-by-step guide for registering a Class A medical device with the Indonesian Ministry of Health (MOH):

Step-by-Step Process for Class A Medical Device Registration

1. Prepare Necessary Documentation

Before initiating the registration process, ensure that you have all the required documents ready. These documents include technical data, safety information, and product details. The basic documents required for the registration include:

• Proof of the Manufacturer’s Authorization: A letter or agreement that authorizes the local distributor or representative to act on behalf of the manufacturer in Indonesia.
• Technical Documentation: A file that includes information about the device’s design, intended use, risk management, and safety profile.
• Certificate of Free Sale (CFS): A document from the manufacturer’s home country certifying that the device is legally marketed and sold there.
• Device Labeling and Instructions for Use (IFU): These must be in Bahasa Indonesia and should comply with local regulatory requirements.
• Quality Management System (QMS) Compliance: Proof of ISO 13485 certification or equivalent (for the manufacturer).
• Product Description and Specifications: Detailed information on the device, including its composition, functions, and operating principles.

2. Choose a Local Authorized Representative or Distributor

If the manufacturer does not have a presence in Indonesia, they must appoint a local authorized representative or distributor. This representative is responsible for submitting the registration application and handling communication with the Indonesian regulatory authorities.

• Role of Local Representative: The authorized representative should be familiar with Indonesian regulatory requirements and will be responsible for submitting the application and maintaining the device registration.

3. Submit the Application to the Ministry of Health (MOH)

Class A medical device registration is done through the Indonesian Ministry of Health (MOH) and is usually handled through the e-registration system.

• e-Registration System: The application for registration must be submitted via the BPOM (Indonesian National Agency of Drug and Food Control) or the Ministry of Health’s online system. The registration platform is designed to streamline the submission process for medical devices.
• Required Information: When submitting the application, you will need to provide detailed information about the device, including its classification (Class A), intended use, and technical documentation. You will also need to upload supporting documents such as the Certificate of Free Sale (CFS) and the ISO 13485 certification.

4. Documentation Review and Evaluation

After submitting the application, the MOH or BPOM will review the technical documentation and application forms to ensure that the device meets all regulatory requirements.

• Evaluation of Technical Documents: The regulatory authorities will assess whether the technical documents comply with Indonesian medical device regulations and if the device is safe and effective for its intended use.
• Assessment of Risk Profile: Since Class A devices are considered low-risk, the evaluation process is generally quicker than for higher-risk devices. However, the authorities will still review aspects such as the risk management plan and post-market surveillance practices.

5. Issuance of Izin Edar (Distribution License)

Once the application has been successfully reviewed and approved by the MOH, the manufacturer or authorized representative will receive an Izin Edar (Distribution License) for the device.

• Izin Edar: This license is mandatory for distributing the medical device in Indonesia and is typically valid for 5 years.
• Certificate of Registration: The device will also receive an official Certificate of Registration from the Ministry of Health, which allows it to be legally marketed and sold in Indonesia.

6. Importation and Distribution

After obtaining the Izin Edar, the device can be imported and distributed within Indonesia. The manufacturer or authorized distributor must ensure that:

• The device complies with Indonesian importation laws and regulations.
• Product labeling and Instructions for Use (IFU) are in Bahasa Indonesia.
• The device is distributed only by the authorized local distributor listed in the registration documents.

7. Post-Market Surveillance (PMS) and Reporting

Once the device is on the market, the manufacturer or distributor must implement post-market surveillance (PMS). This involves monitoring the performance of the device in the market and reporting any adverse events or device-related issues.

• Adverse Events Reporting: Any adverse events or device malfunctions should be reported to the Indonesian Ministry of Health and BPOM.
• Safety Monitoring: Regular reports and monitoring of the device’s performance must be submitted to the regulatory authorities, as required by Indonesian law.

8. Renewal of Izin Edar

The Izin Edar is valid for 5 years. Before it expires, the manufacturer or local representative must apply for renewal. The renewal process is similar to the initial registration and includes updating the technical documentation and submitting any necessary post-market surveillance data.

• Renewal Timeline: It is recommended to start the renewal process 6 months before the Izin Edar expires to avoid any gaps in product distribution.

Summary of the Steps Involved in Class A Medical Device Registration with Indonesia MOH:

1. Prepare Required Documents: Collect technical documentation, certificates, product description, labeling, and ISO certifications.
2. Appoint Local Authorized Representative: Ensure the appointment of a local distributor or representative in Indonesia if needed.
3. Submit Application: Submit the application and required documents through the MOH’s e-registration system.
4. Documentation Review: The MOH reviews the technical documentation, risk profile, and safety of the device.
5. Issuance of Izin Edar: Once approved, the device will receive the Izin Edar (distribution license) and Certificate of Registration.
6. Importation and Distribution: The device can be imported and distributed in Indonesia, provided all labeling and regulatory requirements are met.
7. Post-Market Surveillance: Implement post-market surveillance and report any adverse events to the authorities.
8. Renewal: Apply for Izin Edar renewal 6 months before expiration, ensuring continuous compliance.

Additional Considerations:

• Compliance with SNI Standards: Ensure your device complies with Indonesian National Standards (SNI) for medical devices.
• Labeling Requirements: All labeling, packaging, and Instructions for Use (IFUs) must be in Bahasa Indonesia.
• Inspection Readiness: Be prepared for potential inspections by the MOH or BPOM after registration to ensure compliance with local regulations.

By following these steps, you can successfully register your Class A medical device with the Indonesian Ministry of Health and gain access to the Indonesian market.

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