To register a Class II medical device with the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) in Indonesia, you must submit a range of technical documents that demonstrate the safety, efficacy, and quality of the device. These documents provide evidence that the device complies with regulatory requirements and international standards. Below is a detailed list of the technical document requirements for Class II medical device registration in Indonesia:

1. Certificate of Free Sale (CFS)

• Purpose: This document confirms that the medical device is legally sold and freely marketed in the country of origin.
• Requirements:
  • The CFS should be issued by the relevant health authority or regulatory agency in the country of origin.
  • It should be valid and indicate that the device complies with regulatory requirements in the country of manufacture.
  • If the manufacturer is located outside of Indonesia, this certificate must be submitted to prove that the device is registered and available in the country of origin.

2. ISO 13485 Certificate (Quality Management System)

• Purpose: Proof that the manufacturer complies with ISO 13485, which is the international standard for medical device quality management systems.
• Requirements:
  • The manufacturer should hold a valid ISO 13485 certification that demonstrates compliance with the quality management system for medical devices.
  • This certificate must be issued by a recognized certification body.

3. Good Manufacturing Practices (GMP) Certificate

• Purpose: Evidence that the manufacturer complies with Good Manufacturing Practices (GMP), ensuring the quality and safety of the medical device during production.
• Requirements:
  • GMP certification should be issued by the relevant regulatory body in the country of origin.
  • If the manufacturing facility is in Indonesia, a local GMP certification from BPOM will be required.
  • If the manufacturer is foreign, BPOM may require a GMP inspection or accept GMP certification from the country of origin, provided that the country’s regulations are deemed equivalent.

4. Clinical Evaluation Report (CER)

• Purpose: A report assessing the clinical safety and performance of the medical device based on available clinical data and/or scientific literature.
• Requirements:
  • The CER must demonstrate that the device has been shown to perform as intended without posing unacceptable risks.
  • For Class II devices, BPOM may require the CER to be based on clinical trials, pre-market clinical evaluations, or published scientific literature. If no clinical trials have been conducted, relevant literature or equivalent device data may be used.
  • The CER must be thorough, up-to-date, and follow ISO 14155 (Clinical Investigation of Medical Devices).

5. Risk Management File

• Purpose: To ensure that risks associated with the device are properly identified and mitigated.
• Requirements:
  • A Risk Management Report based on ISO 14971, which provides guidelines for the risk management process for medical devices.
  • The report should document all identified risks, their assessment, and the measures taken to mitigate them.
  • It should also include details on residual risks that remain after mitigation and justify their acceptability.

6. Product Labeling and Instructions for Use (IFU)

• Purpose: To ensure that the device is used correctly and safely by healthcare professionals and patients.
• Requirements:
  • Product labeling: The label should include the device name, manufacturer's information, intended use, safety warnings, and other relevant information in Bahasa Indonesia.
  • Instructions for Use (IFU): The IFU must be written in Bahasa Indonesia and include details on the device’s intended use, contraindications, warnings, precautions, user instructions, and maintenance.
  • BPOM may also require the symbols used on the label to comply with international standards (e.g., ISO 15223).

7. Technical Data (Device Description)

• Purpose: A technical description of the medical device to provide detailed information on its design, components, and intended use.
• Requirements:
  • A clear description of the device, its specifications, and its intended clinical use.
  • Technical drawings (e.g., schematics, diagrams) that illustrate the device’s components, features, and design.
  • Details on the materials used in the device, especially if it comes into contact with the human body.
  • Device performance testing data: Information on how the device performs according to its intended use and any applicable safety tests (e.g., biocompatibility, electrical safety, mechanical performance).

8. Declaration of Conformity (DoC)

• Purpose: A statement by the manufacturer declaring that the device complies with the applicable regulatory requirements.
• Requirements:
  • A Declaration of Conformity (DoC) indicating that the device meets relevant regulatory requirements, including international standards (such as ISO 13485, ISO 14971, ISO 15223).
  • This document should also affirm that the manufacturer has conducted all necessary tests and evaluations to ensure the device is safe and effective.

9. Labeling and Packaging Information

• Purpose: To confirm that the device packaging is safe, complies with labeling regulations, and protects the device.
• Requirements:
  • Detailed information on the device packaging (including the materials used) and how the product is protected during shipping and storage.
  • Labels should comply with BPOM requirements, including a clear product description, usage instructions, and safety information in Bahasa Indonesia.
  • Barcodes and batch numbers for traceability may also be required.

10. Stability Data (If Applicable)

• Purpose: To confirm that the device will remain safe and effective throughout its shelf life.
• Requirements:
  • Stability data showing that the device maintains its performance and safety characteristics throughout its shelf life. This is particularly relevant for products like implants, diagnostics, or devices that have an expiration date.
  • The data should be provided from accelerated or real-time stability studies if applicable.

11. Import License and Distribution Agreement

• Purpose: If the device is being imported to Indonesia, the applicant must show proof of the importation and distribution rights.
• Requirements:
  • A valid import license issued by BPOM.
  • Distribution agreements between the manufacturer and the authorized representative (AR) or distributor in Indonesia.

Summary of Technical Document Requirements for Class II Medical Device Registration

1. Certificate of Free Sale (CFS) from the country of origin.
2. ISO 13485 Certificate for the manufacturer’s quality management system.
3. Good Manufacturing Practices (GMP) Certificate or evidence of GMP compliance.
4. Clinical Evaluation Report (CER) or clinical data demonstrating the device’s safety and performance.
5. Risk Management File based on ISO 14971.
6. Product Labeling and Instructions for Use (IFU) in Bahasa Indonesia.
7. Technical Description including device specifications and performance data.
8. Declaration of Conformity (DoC) affirming compliance with relevant standards.
9. Stability Data (if applicable).
10. Import License and Distribution Agreement (for imported devices).

These documents must be submitted via BPOM’s e-registration system or as requested for Class II medical device registration. Ensuring that the documents are complete, accurate, and compliant with Indonesian regulations will help facilitate the approval process. Would you like assistance with preparing any specific document or step in the registration process?

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