For Class II medical device registration with the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) in Indonesia, there are several key regulatory standards and guidelines that must be adhered to in order to ensure the safety, effectiveness, and quality of the device. These standards align with both Indonesian regulations and international norms for medical devices.

1. Indonesian Regulations (BPOM and MOH)

• Regulation of the Minister of Health No. 62/2017 on Medical Device and Household Health Supplies
  This regulation establishes the framework for the registration, control, and supervision of medical devices in Indonesia. It covers aspects such as device classification, documentation requirements, safety and performance standards, and post-market surveillance.

• BPOM Regulation No. 27/2017 on Medical Device Registration
  This regulation defines the process and requirements for medical device registration, classification, and conformity assessment. It includes guidelines for preparing and submitting registration dossiers, safety evaluations, and technical documentation.

• Indonesian National Standard (SNI) for Medical Devices
  BPOM requires that medical devices comply with relevant SNI (Standar Nasional Indonesia) standards. These standards are Indonesia's national standards for medical devices and their requirements often align with ISO standards (e.g., ISO 13485, ISO 14971).

2. International Standards for Medical Devices

In addition to Indonesian regulations, manufacturers seeking Class II medical device registration in Indonesia must meet international standards, especially those set by organizations such as ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission). The key standards that are commonly applicable to Class II medical devices are:

ISO 13485:2016 - Medical Devices – Quality Management Systems

• Requirement: Manufacturers must implement a quality management system (QMS) that complies with ISO 13485. This standard ensures that medical devices are consistently produced and controlled according to quality standards, covering aspects of design, development, production, installation, and servicing.
• Scope: Applies to manufacturers involved in any stage of the lifecycle of a medical device (from design through production to post-market activities).

ISO 14971:2019 - Medical Devices – Application of Risk Management to Medical Devices

• Requirement: A comprehensive risk management process must be in place. This standard guides manufacturers in identifying hazards, evaluating risks, and implementing strategies to mitigate those risks. A Risk Management Report based on this standard is usually required for Class II device registration in Indonesia.
• Scope: Covers the assessment of device risks, from the design phase through to post-market monitoring.

ISO 9001:2015 – Quality Management Systems

• Requirement: Some manufacturers may also need to demonstrate compliance with ISO 9001 if their device is considered to have an associated general quality management requirement. This standard ensures that an organization can consistently provide products that meet customer and regulatory requirements.

ISO 15197:2013 – In Vitro Diagnostic Test Systems

• Requirement: For in vitro diagnostic (IVD) devices, this standard outlines requirements for the performance and labeling of IVD test systems. If a Class II device falls under the IVD category, this standard would apply.
• Scope: Provides guidance on performance testing, including accuracy, reliability, and quality assurance for diagnostic test systems.

IEC 60601-1 – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance

• Requirement: For electrical medical devices (e.g., diagnostic, therapeutic, or monitoring equipment), IEC 60601-1 is a key standard that addresses safety and performance requirements, including electrical safety.
• Scope: Covers all aspects of medical electrical equipment design, construction, and performance, ensuring that devices are safe and effective for patient use.

ISO 15223-1:2016 - Medical Devices – Symbols to be Used with Medical Device Labels, Labelling, and Information to be Supplied

• Requirement: This standard provides a set of symbols that can be used on device labels and packaging. The symbols must be understandable to users and are typically used for things like handling, storage, and the safe use of devices.
• Scope: Applies to device labeling, ensuring that critical information is communicated clearly, including usage instructions, warnings, and other important details.

ISO 14155:2020 - Clinical Investigation of Medical Devices for Human Subjects

• Requirement: If clinical data is required for the medical device, compliance with ISO 14155 is necessary. This standard provides guidelines on the design, conduct, recording, and reporting of clinical trials for medical devices.
• Scope: Ensures that clinical investigations are conducted ethically and that the results are scientifically valid, supporting the device’s safety and efficacy.

ISO 10993-1:2018 - Biological Evaluation of Medical Devices

• Requirement: For devices that come into contact with the human body (e.g., implants, diagnostic devices), ISO 10993 provides guidelines for biological testing. This includes testing for biocompatibility, cytotoxicity, and other biological responses to the materials in the device.
• Scope: Covers the evaluation of devices for biological safety, including testing for skin irritation, systemic toxicity, and sensitization.

3. BPOM-Specific Requirements

In addition to international standards, BPOM has specific requirements for Class II medical device registration that are tailored to the Indonesian market:

• Risk-Based Classification: BPOM follows a risk-based classification system, with Class II devices considered to have moderate risk. Devices are assessed based on the potential for harm and their intended use.
• Post-Market Surveillance: BPOM mandates post-market surveillance to monitor the safety and effectiveness of medical devices once they are available on the Indonesian market. This includes requirements for adverse event reporting, product recalls, and other regulatory actions if necessary.
• Local Labeling: All devices must have labels and instructions for use (IFU) in Bahasa Indonesia. The label should include information on the device’s intended use, potential risks, and any other required information.
• Importation and Distribution: If the device is imported, BPOM requires that the importer or authorized representative in Indonesia hold the necessary import licenses and distribution rights for the device.

4. Additional Compliance Guidelines

• Health Product Risk Assessment: For some devices, BPOM may request a risk assessment to evaluate the potential health risks posed by the device, especially if it is intended for high-risk procedures or involves invasive procedures.
• Stability Testing: Some devices, especially those with a shelf-life (e.g., diagnostic kits), may require stability testing to ensure they remain safe and effective throughout their intended shelf life.
• Environmental Impact Assessment: Certain devices might require an environmental impact assessment, depending on the nature of the materials used in manufacturing.

Summary of Standards for Class II Medical Device Registration in Indonesia

1. Indonesian Regulations:

   • Regulation of the Minister of Health No. 62/2017
   • BPOM Regulation No. 27/2017

2. International Standards:

   • ISO 13485 (Quality Management Systems)
   • ISO 14971 (Risk Management)
   • ISO 9001 (General Quality Management)
   • ISO 15197 (In Vitro Diagnostic Devices)
   • IEC 60601-1 (Electrical Equipment Safety)
   • ISO 15223-1 (Labeling Symbols)
   • ISO 14155 (Clinical Investigations)
   • ISO 10993-1 (Biological Safety)

3. BPOM-Specific Guidelines:

   • Risk-based classification system for Class II devices
   • Post-market surveillance requirements
   • Local labeling and Bahasa Indonesia instructions
   • Importation and distribution requirements

By ensuring compliance with these standards and regulatory requirements, manufacturers can successfully navigate the registration process for Class II medical devices in Indonesia. Would you like additional details on any of these standards or assistance with another part of the registration process?