MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong is governed by various regulatory standards and guidelines. These standards ensure that medical devices are safe, effective, and manufactured in compliance with quality assurance practices. Here are the key standards and regulations that govern MDACS registration for Class IV IVD medical devices:

Key Standards and Regulations

1. Medical Device Ordinance (Cap. 663):

   • This is the primary legislation governing the regulation of medical devices in Hong Kong. It outlines the framework for the classification, registration, and post-market surveillance of medical devices.

2. Guidance Notes for Medical Device Registration:

   • Issued by the Medical Device Control Office (MDCO), these guidance notes provide detailed information on the registration process, including documentation requirements, application procedures, and standards for specific device types.

3. ISO 13485:2016 - Quality Management Systems for Medical Devices:

   • This international standard specifies the requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

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

   • This standard provides a framework for managing risks associated with medical devices throughout their lifecycle. It emphasizes risk analysis, evaluation, control, and post-market surveillance.

5. ISO/IEC 17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories:

   • If the IVD device involves laboratory testing, this standard may apply to ensure the accuracy and reliability of test results.

6. IEC 62304:2006 - Medical Device Software – Software Life Cycle Processes:

   • For devices that include software, this standard outlines the requirements for the lifecycle processes of medical device software, ensuring its safety and effectiveness.

7. ISO 15189:2012 - Medical Laboratories – Particular Requirements for Quality and Competence:

   • This standard is applicable to medical laboratories and specifies the requirements for quality and competence in laboratory medicine.

8. Clinical Guidelines:

   • Clinical evidence should be supported by relevant clinical guidelines and practices, which may include data from regulatory agencies, such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA), if applicable.

9. International Medical Device Regulators Forum (IMDRF) Guidelines:

   • While not legally binding, the IMDRF provides guidelines and best practices for medical device regulation, which can influence local regulatory frameworks.

Compliance with Local and International Standards

• Local Compliance: It is essential for manufacturers to comply with the local regulatory requirements set forth by the MDCO and the Medical Device Ordinance.
• International Standards: Compliance with internationally recognized standards can enhance the credibility of the device and facilitate registration processes in multiple jurisdictions.

Summary

In summary, MDACS registration for Class IV in vitro diagnostic medical devices is governed by a combination of local laws, guidelines, and international standards that ensure the safety, quality, and effectiveness of medical devices. Manufacturers must be familiar with these standards to successfully navigate the registration process and maintain compliance.

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