For Class C medical device registration with Singapore's Health Sciences Authority (HSA), the devices must comply with relevant international and regional standards to ensure their safety, quality, and efficacy. These standards address various aspects such as design, manufacturing, performance, and post-market surveillance.

Here are the key standards for Class C medical device registration with HSA:

1. ISO 13485:2016 (Quality Management Systems)

• ISO 13485 specifies the requirements for a quality management system (QMS) for medical device manufacturers.
• It ensures that the manufacturer follows appropriate practices to maintain the safety and quality of the device.
• It is crucial for demonstrating compliance with Good Manufacturing Practice (GMP) requirements.
• This standard should be adhered to throughout the design, manufacturing, and post-market activities.

2. ISO 14971:2019 (Risk Management for Medical Devices)

• This standard provides a systematic approach to risk management for medical devices.
• It requires manufacturers to identify potential risks associated with the device, assess their impact, and implement appropriate risk controls to mitigate them.
• A Risk Management Report, following ISO 14971, is required for Class C devices to demonstrate that all safety risks have been identified and controlled.

3. ISO 10993-1:2018 (Biological Evaluation of Medical Devices)

• If the medical device is in contact with the human body, this standard governs the biological safety of the materials used in the device.
• Biocompatibility testing (e.g., cytotoxicity, sensitization, irritation) must be performed in line with this standard to ensure that the materials do not cause harm when used as intended.

4. IEC 60601-1:2005 + A1:2012 + A2:2020 (Medical Electrical Equipment - General Requirements for Safety and Performance)

• This standard applies to medical electrical equipment and focuses on the safety and performance of electrical medical devices.
• It includes tests for electrical safety, mechanical safety, and electromagnetic compatibility (EMC).
• Class C devices that are electrical or electronic (e.g., diagnostic machines, therapeutic devices) must meet this standard to ensure safe operation and compliance with health and safety regulations.

5. IEC 62366-1:2015 (Application of Usability Engineering to Medical Devices)

• This standard focuses on the usability of medical devices, ensuring that they are designed for safe and effective use.
• It covers the identification and mitigation of potential usability-related risks to improve the user experience, especially for medical professionals and patients.

6. ISO 14155:2020 (Clinical Investigation of Medical Devices for Human Subjects)

• If clinical trials are conducted to demonstrate the safety and performance of a Class C device, they must comply with this standard.
• It outlines the good clinical practice (GCP) requirements for clinical investigations, including protocols, ethics review, and informed consent.

7. ISO 20417:2021 (Medical Devices - Information to be Provided by the Manufacturer)

• This standard specifies the information to be included in the labeling and instructions for use (IFU) of medical devices.
• The labeling must include details like the device's name, intended use, warnings, and precautions in compliance with local regulatory requirements.

8. ISO 11737-1:2006 (Sterilization of Medical Devices – Microbiological Methods)

• For devices that are sterile at the point of use, this standard specifies the microbiological testing methods used to verify the effectiveness of the sterilization process.
• Compliance with this standard ensures that the device is free from microbial contamination when used.

9. ISO 62304:2006 (Software Life Cycle Processes)

• If the medical device includes software, this standard provides requirements for the development and maintenance of software used in medical devices.
• It covers areas such as risk management, verification, validation, and documentation of software life cycle processes.

10. ISO 10993-5:2009 (Biological Evaluation of Medical Devices - Tests for In Vitro Cytotoxicity)

• This is an important standard if the device or its components come into direct or indirect contact with human tissues.
• It outlines in vitro testing methods to assess the cytotoxicity of materials used in the device.

11. Good Manufacturing Practice (GMP) Requirements

• The manufacturer must comply with Good Manufacturing Practice (GMP) guidelines, which ensure the devices are consistently produced and controlled to quality standards.
• This requirement is generally addressed through ISO 13485 certification.

12. Regulatory Requirements for Labeling and Packaging:

• Devices must comply with HSA's labeling and packaging regulations.
• This includes providing appropriate warnings, symbols, directions for use, and storage conditions.
• The device’s packaging must be safe and secure, ensuring that the device is protected from damage during transportation and storage.

13. Post-Market Surveillance and Vigilance:

• Manufacturers are required to have systems in place to monitor the device's performance after it is placed on the market.
• The post-market surveillance plan should outline procedures for monitoring adverse events, recall procedures, and other safety-related actions.

14. Singapore-Specific Requirements:

• HSA's Essential Principles of Safety and Performance: These are fundamental principles that devices must meet to be marketed in Singapore. The device must:
  • Be safe and effective for its intended purpose.
  • Perform as expected in normal use.
  • Be designed to minimize risks to health.
  • Comply with the labeling and packaging requirements set out by HSA.

How to Demonstrate Compliance with These Standards:

• For each of these standards, the applicant must submit appropriate documentation, such as:
  • Certificates of conformity (e.g., ISO 13485, ISO 14971).
  • Test reports and clinical data (e.g., EMC testing, biocompatibility testing).
  • Manufacturer’s declarations and quality assurance records.
  • A clinical evaluation report (CER) if clinical trials are required.

By adhering to these standards, medical device manufacturers ensure that their Class C devices are safe, effective, and compliant with regulatory requirements for the Singapore market.

If you need more specific guidance on any of the standards or how to meet the requirements, feel free to ask!

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