For D-class medical device registration with the Health Sciences Authority (HSA) in Singapore, the device must meet specific regulatory standards to ensure its safety, effectiveness, and quality. These standards are aligned with international best practices and are essential for ensuring that the device performs as intended without posing undue risks to patient health.

Key Standards for D-Class Medical Device Registration in Singapore HSA:

1. ISO 13485: Quality Management System (QMS)

   • ISO 13485 is the international standard that outlines the requirements for a quality management system specific to medical devices.
   • Manufacturers must have a certified QMS to ensure consistent design, production, and post-market activities that meet customer and regulatory requirements.
   • The QMS must be documented and include processes for design control, production control, risk management, and continuous improvement.

2. ISO 14971: Risk Management for Medical Devices

   • ISO 14971 specifies the process for risk management for medical devices.
   • D-class medical devices, being high-risk devices, must comply with the standard's requirements for identifying, assessing, and mitigating risks throughout the lifecycle of the device.
   • The manufacturer must conduct a risk analysis to identify hazards, evaluate risks, and implement risk control measures to minimize potential harm to patients and users.
   • A Risk Management Plan and Risk Analysis Report must be submitted as part of the registration.

3. ISO 10993: Biological Evaluation of Medical Devices

   • ISO 10993 is a series of standards that provides guidelines for the biological evaluation of medical devices.
   • D-class devices that are implantable or have body contact must undergo biocompatibility testing to ensure that materials used in the device do not pose biological risks.
   • The testing may include evaluations for cytoxicity, sensitization, irritation, genotoxicity, and systemic toxicity, depending on the nature of the device and the duration of contact with the body.

4. IEC 60601: Safety and Performance of Electrical Medical Devices

   • IEC 60601 is an international standard for the safety and performance of electrical medical devices.
   • If the D-class device involves electrical components, it must comply with the relevant parts of IEC 60601 to ensure that it operates safely under expected conditions.
   • The device should undergo electromagnetic compatibility (EMC) testing, electrical safety testing, and other relevant tests to ensure patient and user safety.

5. Good Manufacturing Practice (GMP)

   • The GMP standard outlines the manufacturing practices required to ensure that medical devices are produced consistently and meet quality standards.
   • Manufacturers must demonstrate compliance with GMP guidelines for design, manufacturing, testing, and post-market monitoring.
   • The GMP compliance certification, or equivalent certification, must be submitted if applicable.

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

   • ISO 14155 provides guidance on the clinical investigation of medical devices to evaluate their safety and performance.
   • For D-class devices that require clinical trials to demonstrate safety and efficacy, manufacturers must ensure that the trials are conducted in accordance with ISO 14155.
   • This includes obtaining ethical approvals, informed consent, and following Good Clinical Practice (GCP) principles.

7. ISO 20417: Labeling of Medical Devices

   • ISO 20417 outlines the labeling requirements for medical devices, ensuring that users and patients have the necessary information to use the device safely and effectively.
   • D-class devices must have clear and accurate labels, including product name, intended use, warnings, contraindications, and other essential information.
   • The Instructions for Use (IFU) must also be included, outlining step-by-step usage instructions.

8. IEC 62366: Usability Engineering for Medical Devices

   • IEC 62366 specifies the requirements for usability engineering and the human factors associated with medical devices.
   • The standard ensures that devices are designed in a way that minimizes use errors, especially in high-risk D-class devices that require accurate operation for patient safety.
   • Manufacturers must provide evidence of usability testing and considerations to ensure that the device is intuitive and safe to use.

9. Harmonized Standards and Conformity Assessment

   • Manufacturers are encouraged to use harmonized standards recognized by regulatory bodies globally, including the European Union (EU) and FDA.
   • While these standards are not mandatory, using them can demonstrate conformity with International Medical Device Regulators Forum (IMDRF) guidelines and facilitate faster approval.

Compliance with International Standards:

• Manufacturers are encouraged to adopt recognized international standards such as ISO and IEC to demonstrate the device's safety and efficacy. The use of these standards is a critical part of HSA's conformity assessment process for D-class devices.

• In addition to the above standards, the Health Sciences Authority (HSA) may apply additional local regulatory requirements as specified in the Health Products Act and its associated regulations.

Summary of Key Standards for D-Class Medical Device Registration in Singapore HSA:

1. ISO 13485: Quality Management System.
2. ISO 14971: Risk Management for Medical Devices.
3. ISO 10993: Biological Evaluation of Medical Devices.
4. IEC 60601: Electrical Safety and Performance of Medical Devices.
5. Good Manufacturing Practice (GMP).
6. ISO 14155: Clinical Investigation for Medical Devices.
7. ISO 20417: Labeling of Medical Devices.
8. IEC 62366: Usability Engineering.
9. Harmonized Standards for conformity assessment.

By adhering to these standards, manufacturers can ensure their D-class medical device complies with HSA's regulatory requirements and can be safely marketed in Singapore.

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