For Class C medical device registration in Indonesia under the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control), several technical documents are required to demonstrate that the medical device complies with the safety, performance, and regulatory requirements set by Indonesian authorities.

Here’s a detailed list of the technical document requirements you will need to prepare for the application process:

1. Device Description and Classification

• Device Description: A clear description of the medical device, including its intended use, indications, functionality, and how it is intended to be used.
• Device Classification: A classification justification, confirming that the device is correctly classified as Class C. BPOM evaluates devices based on risk, and Class C includes devices with moderate to high risk (e.g., surgical instruments, diagnostic devices).
• Standards Compliance: Information on whether the device meets specific Indonesian National Standards (SNI) or international standards (e.g., ISO 13485, IEC 60601 for electrical devices, etc.).

2. Risk Management Documentation

• Risk Management Plan: A risk management file based on ISO 14971 outlining all identified risks related to the device and how those risks are mitigated. This document should include:
  • Identification of risks related to design, manufacturing, and usage.
  • Assessment of those risks.
  • Strategies or measures to reduce or eliminate risks.
  • Risk control measures implemented during the design and production stages.

3. Clinical Evaluation Report

• Clinical Data: A clinical evaluation report that includes data proving the safety and performance of the device. This can include:
  • Clinical trials or studies (if applicable).
  • Clinical data from other countries or markets where the device is already approved (e.g., FDA, CE).
  • If the device is already marketed in other countries, provide clinical evidence demonstrating that the device performs as intended.
  • Any adverse events or post-market surveillance data from existing markets, if applicable.
• Clinical Evaluation: A summary of clinical studies and evaluations showing that the device meets the essential requirements for safety and efficacy.

4. Labeling and Instructions for Use (IFU)

• Labeling Requirements: Labels should comply with BPOM regulations and must be in Bahasa Indonesia. The labeling should include:
  • Device name, model, and serial number.
  • Manufacturer or distributor details.
  • Intended use and indications.
  • Warnings, contraindications, and precautions.
  • Expiry date, batch number, or lot number (if applicable).
• Instructions for Use (IFU): Clear instructions for the safe and correct use of the device, also in Bahasa Indonesia. It should include:
  • How the device should be used.
  • Any potential risks or side effects.
  • Step-by-step instructions for handling, maintaining, and disposing of the device.

5. Manufacturing and Quality Management Documentation

• GMP (Good Manufacturing Practice) Certificate: A GMP certificate from the manufacturing facility, indicating that the facility complies with good manufacturing practices. This certification should be up-to-date and from an authorized regulatory body (e.g., FDA, EMA, or local authorities).
• Manufacturing License: A valid manufacturing license issued by the regulatory authorities in the country of origin of the device. This demonstrates that the manufacturer is authorized to produce medical devices.

6. Biocompatibility and Safety Testing

• Biocompatibility Testing: If the device is in contact with the human body (e.g., implants, catheters, or other invasive devices), you must provide biocompatibility testing data according to ISO 10993 standards. This ensures that materials used in the device do not cause harm to users.
• Performance Testing: If applicable, include any performance testing results that validate the device’s functionality, especially for complex devices like diagnostic or surgical equipment.
  • This may include electrical safety tests (IEC 60601) for electrical devices.
  • Sterility assurance and testing for sterile devices.

7. Certificate of Free Sale (CFS)

• CFS: A Certificate of Free Sale (CFS) from the country of origin (the country where the device is manufactured or has already been marketed), confirming that the device is legally sold in the home market and complies with relevant regulatory standards (e.g., FDA, CE, etc.).
• Translation of CFS: The CFS must be translated into Bahasa Indonesia and be signed by the competent authority.

8. Stability Data (If Applicable)

• For devices that are subject to stability concerns (e.g., sterile devices, single-use devices), you will need to provide stability data. This includes:
  • The shelf life of the device.
  • Data showing that the device maintains its intended performance and safety during its lifespan.
  • Storage and handling conditions.

9. Product Testing (If Required by BPOM)

• BPOM may require performance testing or further safety testing depending on the type of device.
  • This could include electrical safety tests, performance validation, and functional testing to prove that the device performs as expected under its intended conditions.
  • If additional tests or inspections are required, BPOM will request these documents as part of their review process.

10. Distribution and Post-Market Surveillance Plan

• Post-Market Surveillance (PMS) Plan: A plan for monitoring the device’s performance in the market after it has been released. This includes:
  • Adverse event reporting procedures.
  • Recall procedures (if necessary).
  • Continuous monitoring of the device’s safety and effectiveness during its lifecycle.
• Distribution Information: Information about the device’s distribution network in Indonesia, ensuring that the device is sold through authorized distributors or dealers.

11. Additional Regulatory Information (If Applicable)

• International Regulatory Approvals: If the device has been approved by other regulatory authorities such as the FDA (USA), EMA (Europe), TGA (Australia), or PMDA (Japan), include these approval documents to support the application.
• ISO Certifications: If the device manufacturer holds ISO certifications (e.g., ISO 13485 for medical device quality management), include these documents as they demonstrate the manufacturer’s commitment to quality control.

Document Checklist Summary for Class C Medical Device Registration in Indonesia:

1. Device Description and Classification
2. Risk Management Documentation (ISO 14971)
3. Clinical Evaluation Report
4. Labeling and Instructions for Use (in Bahasa Indonesia)
5. GMP Certificate and Manufacturing License
6. Biocompatibility Testing (ISO 10993) and Performance Testing
7. Certificate of Free Sale (CFS)
8. Stability Data (if applicable)
9. Product Testing (if required by BPOM)
10. Post-Market Surveillance Plan
11. International Regulatory Approvals (if applicable)
12. ISO Certifications (if applicable)

Document Preparation Tips:

• Translation: Ensure that all documents, particularly labeling and IFUs, are translated into Bahasa Indonesia as this is a mandatory requirement.
• File Format: Most documents should be submitted in PDF format unless otherwise specified by BPOM.
• Compliance: Double-check all regulatory standards and guidelines set by BPOM to ensure full compliance with local requirements.

By preparing all the above technical documents in detail, you will be able to complete your Class C medical device registration process in Indonesia successfully. Let me know if you need assistance with any specific documents or further details!

Contact Us：

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