When registering a Class II in vitro diagnostic (IVD) medical device in Hong Kong under the Medical Device Administrative Control System (MDACS), several standards and guidelines must be adhered to ensure compliance with regulatory requirements. Here are the key standards relevant to the registration of Class II IVDs:

Key Standards for Class II IVD Registration

1. ISO 13485:2016 - Quality Management Systems

   • This standard outlines the requirements for a comprehensive quality management system specifically for organizations involved in the design, production, installation, and servicing of medical devices.
   • Compliance with ISO 13485 is essential for demonstrating effective quality management practices throughout the product lifecycle.

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

   • This standard provides a framework for the risk management process, including risk assessment, control, and evaluation, tailored to medical devices.
   • Manufacturers must identify potential risks associated with their IVDs and implement strategies to mitigate these risks throughout the device's lifecycle.

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

   • While this standard primarily pertains to medical laboratories, it can be relevant for IVDs used in laboratory settings.
   • It outlines requirements for quality management systems and competence for medical laboratories, ensuring reliable and accurate testing results.

4. ISO 9001:2015 - Quality Management Systems

   • Although not specific to medical devices, ISO 9001 provides a general framework for quality management that can complement ISO 13485.
   • It emphasizes customer satisfaction, continuous improvement, and process efficiency, which are beneficial for any organization.

5. IEC 62304:2006/A1:2015 - Medical Device Software - Software Life Cycle Processes

   • This standard applies to software used in medical devices, including software integral to IVDs.
   • It outlines the life cycle processes necessary for the safe and effective design and maintenance of medical device software.

6. IEC 61010-1:2010 - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use

   • This standard applies to electrical equipment, including IVDs, and specifies safety requirements to ensure safe operation and protection of users.

7. ISO 18113 - In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer

   • This set of standards addresses the labeling and information requirements for IVDs, ensuring that users receive adequate instructions and information for safe and effective use.

8. Clinical Evaluation Standards (e.g., ISO 20916)

   • These standards pertain to the clinical performance evaluation of IVDs, providing guidelines for conducting performance studies and evaluating clinical data to support claims of safety and efficacy.

9. Good Manufacturing Practice (GMP)

   • Compliance with GMP is crucial to ensure that medical devices are produced consistently and controlled according to quality standards. It encompasses all aspects of production, from the raw materials to the training of personnel.

Regulatory Guidelines

In addition to the aforementioned standards, manufacturers should also familiarize themselves with the following guidelines and documents from the Hong Kong Department of Health:

• MDACS Guidelines for Medical Device Registration
• Guidance on the Registration of In Vitro Diagnostic Medical Devices
• Local Regulations: Adhere to the Medical Device Ordinance (Cap. 663) and associated regulations.

Summary

For Class II IVD registration in Hong Kong, compliance with standards such as ISO 13485, ISO 14971, and IEC 62304 is essential. These standards address quality management, risk management, software development, and labeling requirements. Familiarizing yourself with these standards and relevant regulatory guidelines will help ensure a successful registration process under MDACS.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn