Standards for Class A Medical Device Registration with Indonesia MOH

For Class A medical device registration with Indonesia's Ministry of Health (MOH), compliance with both international and Indonesian national standards is required. These standards ensure that the medical device is safe, effective, and of high quality. Below are the key standards you should be aware of when registering a Class A medical device in Indonesia:

1. Indonesian National Standards

Indonesia has its own set of standards and regulations governing medical devices. These are primarily enforced through the Ministry of Health (MOH) and BPOM (Badan Pengawas Obat dan Makanan), the Indonesian Food and Drug Authority.

• Regulation No. 62/2017: This is the primary regulation governing the supervision of medical devices and household health supplies in Indonesia. It outlines the requirements for the registration, distribution, and quality control of medical devices.

  • This regulation sets the basic framework for medical device classification, quality assurance, and post-market surveillance.
  • Class A devices, being low-risk, have fewer requirements compared to higher-risk devices (Class B, C, D).

• BPOM Regulations: BPOM is responsible for overseeing medical device safety in Indonesia. Medical devices must meet BPOM’s requirements for safety, efficacy, and manufacturing quality. For registration, BPOM often follows international guidelines and harmonizes them with local needs.

• Indonesian National Standard (SNI): Indonesia has several national standards (SNI - Standar Nasional Indonesia) that medical devices must adhere to. These standards are based on international norms but may include additional local specifications:

  • SNI ISO 13485: Quality Management Systems for medical devices (similar to the international standard).
  • SNI 01-7687-2013: A local standard that deals with labeling requirements for medical devices in Indonesia.

• Indonesian Guidelines for Medical Device Registration: The Indonesian MOH's guidelines for medical device registration outline the required technical documentation, including risk management files, product labeling, safety and performance data, and risk analysis.

2. International Standards

In addition to Indonesian regulations, Indonesia often requires compliance with recognized international standards to ensure the safety and quality of medical devices. These standards include:

• ISO 13485:2016 – Quality Management System for Medical Devices:

  • This standard is a key requirement for manufacturers to demonstrate their ability to consistently design, develop, and manufacture medical devices that meet both customer and regulatory requirements.
  • ISO 13485 certification is required to prove that the manufacturer has implemented a quality management system that adheres to best practices for medical device production.

• ISO 14971:2019 – Risk Management for Medical Devices:

  • Class A devices, while low-risk, must still undergo a risk management process in line with ISO 14971. This involves identifying potential risks associated with the device, evaluating those risks, and implementing controls to mitigate them.
  • Even for low-risk devices, a risk analysis must be documented and submitted as part of the registration.

• IEC 60601-1 (Electrical Safety):

  • For electrical medical devices, compliance with IEC 60601-1 is often required. This standard ensures that the device is safe in terms of electrical hazards, including insulation, grounding, and protection against electrical shock.

• ISO 10993 (Biocompatibility):

  • For devices that come into contact with the human body, compliance with ISO 10993 (Biocompatibility) is necessary. This standard defines the biological evaluation requirements for medical devices, ensuring that they are safe for human use.
  • For Class A devices, this may not be required unless the device has direct or prolonged contact with patients.

• ISO 11737 – Sterilization and Microbial Evaluation:

  • If the Class A device is sterile, compliance with ISO 11737 (Sterilization of medical devices) and the corresponding microbial validation standards is required.
  • The device must demonstrate sterility assurance levels (SAL) through validated sterilization processes.

• ISO 7000 – Graphical Symbols for Use on Medical Device Labels:

  • Compliance with this standard ensures that the labeling of the device meets internationally recognized symbols and icons for medical devices.
  • This ensures that users can easily interpret the instructions and warnings on the device’s labeling.

3. Other Relevant Standards

Depending on the type of Class A medical device, additional standards may apply:

• ISO 15223-1 – Medical Device Labeling:

  • This standard covers labeling requirements for medical devices, including symbols and text that must be used on packaging, user manuals, and instructions for use (IFU). The goal is to ensure clear and accurate communication about the device.

• ISO 11137 – Sterilization of Healthcare Products:

  • For Class A devices that require sterilization, compliance with ISO 11137 ensures that sterilization processes are validated, and the device maintains sterility during use.

• IEC 61010 – Safety Requirements for Electrical Equipment:

  • For electrical devices, this standard specifies safety requirements for electrical equipment used in medical environments. It covers aspects like electromagnetic compatibility (EMC), grounding, and user safety.

4. Documentation and Substantiation

In addition to compliance with standards, you must provide documentation to substantiate compliance, including:

• Technical File: A comprehensive technical file that demonstrates how the device meets relevant standards (e.g., test reports, certification, risk management files).
• Clinical Evidence (if applicable): Even for Class A devices, clinical evidence may be required in some cases (e.g., for devices that involve new technology or diagnostic functions).
• Labeling Compliance: Labels and user manuals must meet both local and international standards, and they must be translated into Bahasa Indonesia.

Key Standards for Class A Device Registration:

1. Indonesian Standards:
   • Regulation No. 62/2017 (MOH regulation on medical devices).
   • SNI (Standar Nasional Indonesia) – National Standards for medical device labeling and registration.
2. International Standards:
   • ISO 13485 – Quality Management System for medical devices.
   • ISO 14971 – Risk management for medical devices.
   • IEC 60601-1 – Electrical safety (for electrical devices).
   • ISO 10993 – Biocompatibility (for devices in contact with the human body).
   • ISO 11737 – Sterilization and microbial evaluation.
3. Specific Device Standards:
   • Depending on the nature of the device, additional standards may apply (e.g., ISO 15223-1 for labeling, IEC 61010 for electrical safety).

Summary of Compliance

• Class A medical devices must comply with Indonesian regulations and international standards for quality, safety, performance, and risk management.
• ISO 13485 certification and ISO 14971 risk management are key to the registration process.
• Documentation must substantiate that the device meets the applicable standards, including those for safety, performance, labeling, and biocompatibility.

Let me know if you'd like additional details on any specific standards or need help with document preparation!