For Class 3 medical device registration in Indonesia, the following international standards and local regulatory requirements apply to ensure that the device meets safety, performance, and quality requirements. These standards are referenced by the Indonesian Ministry of Health (MOH), through the Badan Pengawas Obat dan Makanan (BPOM), during the evaluation and registration process for high-risk devices. Below are the key standards applicable to Class 3 medical devices in Indonesia:

1. International Standards

Class 3 medical devices are high-risk devices, which require stringent adherence to international standards related to design, safety, clinical evaluation, and quality control. These standards include:

a. ISO 13485: Quality Management System

• ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes.
• This standard sets out the requirements for a Quality Management System (QMS) specific to medical devices. Manufacturers must demonstrate that they have a QMS in place that ensures the consistent production and monitoring of medical devices.
• BPOM requires compliance with ISO 13485 for manufacturers to demonstrate effective quality control, risk management, and traceability of medical device production.

b. ISO 14971: Risk Management

• ISO 14971: Medical devices — Application of risk management to medical devices.
• This standard outlines a systematic approach to risk management, including risk assessment, risk evaluation, and risk control measures for medical devices.
• BPOM requires that medical device manufacturers provide a risk management file demonstrating how risks have been identified and mitigated during the design, manufacture, and post-market phases of the device’s lifecycle.

c. ISO 10993: Biological Evaluation

• ISO 10993: Biological evaluation of medical devices.
• This standard defines the biocompatibility requirements for medical devices in contact with the human body. It includes tests such as cytotoxicity, irritation, sensitization, and systemic toxicity testing.
• For Class 3 medical devices, especially those in direct contact with the body (e.g., implants), BPOM requires biocompatibility testing reports as part of the registration documentation.

d. IEC 60601: Medical Electrical Equipment

• IEC 60601: Medical electrical equipment — Part 1: General requirements for safety, Part 2: Specific requirements for basic safety and essential performance.
• This international standard covers the electrical safety and performance of medical electrical equipment.
• Class 3 medical devices that are electrical (e.g., diagnostic equipment, therapeutic devices) must comply with IEC 60601 to demonstrate that the device is safe to use and does not pose electrical hazards to patients and users.

e. ISO 14155: Clinical Investigation

• ISO 14155: Clinical investigation of medical devices for human subjects — Good clinical practice.
• This standard outlines the guidelines for conducting clinical trials on medical devices. It ensures that clinical trials are performed ethically and scientifically to demonstrate the safety and efficacy of the device.
• BPOM requires clinical trial data for Class 3 medical devices to support the device’s safety and performance claims.

f. IEC 61000: Electromagnetic Compatibility (EMC)

• IEC 61000: Electromagnetic compatibility (EMC).
• For electrical medical devices, this standard addresses the electromagnetic interference (EMI) and electromagnetic susceptibility (EMS) of the device.
• Devices must meet the EMC requirements to ensure they do not cause interference with other devices or equipment in a medical setting.

g. ISO 20857: Sterilization

• ISO 20857: Sterilization of medical devices — Quality requirements for the sterilization of medical devices.
• For medical devices that are sterilized before use (e.g., surgical instruments), compliance with this standard ensures that the sterilization process is validated and the device is free from pathogens.

2. Indonesian Regulatory Standards and Requirements

In addition to the international standards, there are specific Indonesian regulations and BPOM guidelines that apply to Class 3 medical device registration:

a. BPOM Regulation No. 27 of 2017

• Regulation No. 27 of 2017: This regulation governs the registration of medical devices in Indonesia and outlines the requirements for different classes of medical devices, including Class 3.
• It specifies the documentation requirements, including the need for clinical data, performance testing, post-market surveillance, and risk management documentation for Class 3 devices.

b. Decree of the Minister of Health of the Republic of Indonesia No. 72/2016

• Decree No. 72/2016: This decree outlines the general provisions for medical device registration in Indonesia, including the classification of medical devices, the approval process, and the responsibilities of importers and distributors.
• It includes detailed technical requirements for the registration of high-risk devices (Class 3), such as clinical evaluations and compliance with international standards (e.g., ISO 13485, ISO 14971).

c. BPOM Technical Guidelines

• BPOM guidelines provide detailed instructions for the submission process and documentation requirements for medical device registration in Indonesia.
• These guidelines often reference international standards such as ISO 13485 and ISO 14971, and specify additional local requirements for clinical data, risk management, device labeling, and post-market surveillance.

d. Local Standards for Medical Device Labelling

• Labelling Requirements: BPOM requires that medical device labels and Instructions for Use (IFU) be in Bahasa Indonesia and meet local formatting guidelines.
• Labels should contain essential information such as the device name, indications for use, warnings, contraindications, manufacturer’s details, and storage instructions.

e. Good Manufacturing Practice (GMP)

• Compliance with Good Manufacturing Practices (GMP) is required for medical device manufacturing, as stipulated in BPOM regulations. BPOM may inspect the manufacturing facility for compliance with GMP, particularly for Class 3 devices.

3. Summary of Key Standards for Class 3 Medical Device Registration in Indonesia

• ISO 13485: Quality management system for medical devices.
• ISO 14971: Risk management for medical devices.
• ISO 10993: Biocompatibility testing.
• IEC 60601: Electrical safety and performance for medical electrical equipment.
• ISO 14155: Clinical investigation and good clinical practice.
• IEC 61000: Electromagnetic compatibility (EMC).
• ISO 20857: Sterilization requirements for medical devices.
• BPOM Regulation No. 27 of 2017: BPOM’s regulation for medical device registration.
• Decree No. 72/2016: Ministerial decree regarding medical device registration.
• Local labelling and GMP requirements as outlined by BPOM.

Conclusion

Class 3 medical device registration in Indonesia is a comprehensive process that requires compliance with both international standards (such as ISO 13485, ISO 14971, and IEC 60601) and local regulatory requirements outlined by BPOM. Manufacturers must demonstrate the safety, efficacy, and quality of their device through various technical documents, including clinical trial data, performance test results, and risk management documentation. Ensuring that these standards are met is crucial for successful registration and approval of Class 3 medical devices in Indonesia.

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