Quality Management System Establishment

      The quality management system is an important part of the verification of the medical device registration system and daily supervision and inspection. Enterprises should establish and implement a quality management system in accordance with the specific requirements of regulations. Enterprises should conduct self-inspections in accordance with “Good Manufacturing Practice for Medical Devices” and “Guiding Principles for On-site Inspection of Good Manufacturing Practice for Medical Devices” (including on-site inspection guidelines for sterile medical devices, on-site inspection guidelines for implantable medical devices, and on-site inspection guidelines for in vitro diagnostic reagents) to meet compliance requirements and ensure product quality.

      The medical device production quality management system is an important means to control the entire production process of medical devices, reduce product risks, and ensure the safety and effectiveness of medical devices. It is also a basic content for evaluating the quality of medical devices. The quality level of medical device products mostly depends on the perfection of the quality system level of the enterprise. Therefore, building a reasonable, complete and effective quality management system has become a strong support for corporate compliance, health and sustainable development.

      According to Article 35 of the “Regulations on the Supervision and Administration of Medical Devices” (Order No. 739 of the State Council of the People’s Republic of China), medical device registrants, filers, and entrusted production enterprises shall establish and improve the medical device production quality management standards in accordance with the medical device production quality management standards. Medical device registrants, filers, and entrusted manufacturing enterprises shall regularly conduct self-examinations on the operation of the quality management system and submit self-inspection reports in accordance with the regulations of the State Council’s drug regulatory department.

Which types of enterprises need to establish a medical device production quality management system?

  • Manufacturing enterprise of Class Ⅰ medical device
  • Filer of Class Ⅰ medical device
  • Manufacturing enterprise of Class Ⅱ and Class Ⅲ medical device
  • Registrants for Class II and Class III medical devices
  • All enterprises applying for registration and production of medical devices

      The above-mentioned enterprises should establish a medical device production quality management system, then improve it and ensure its effective operation. The production of medical devices must be carried out in strict accordance with the registered or filed product technical requirements to ensure that the medical devices from factories meet the mandatory standards and the registered or filed product technical requirements.

What are the regulatory bases for medical device manufacturers to establish quality management systems?

      Medical device manufacturers should establish a production quality management system in strict accordance with relevant regulations and/or standards, hereinafter referred to as the GMP system. Enterprises should refer or partially refer to the requirements of the above regulations and standards, and gradually establish a production quality management system suitable for themselves, so as to not only meet the requirements of regulations, but also adapt to the development of the enterprise. Some relevant regulations and standards are as follows:

  • Regulations on the Supervision and Administration of Medical Devices
  • Measures for the Supervision and Administration of Medical Device Production
  • Medical device production quality management specifications
  • Guiding principles for on-site inspection of medical device production quality management specifications
  • Management Guidelines for Manager Representatives of Medical Device Manufacturing Enterprises
  • YY0033 Good Manufacturing Practice for Sterile Medical Devices
  • ISO 13485 Medical device quality management system for regulatory requirements

What are the steps for medical device manufacturers to establish a quality management system?

  • Planning and implementation of enterprise hardware
  • Planning and recruitment of corporate personnel
  • Planning and assessment of department positions and responsibilities
  • Job training and assessment of corporate personnel
  • Establish quality management system documents
  • Quality management system document promotion and trial operation
  • Implementation and operation of quality management system
  • Continuous improvement of quality management system operation

      The medical device production quality management system is an important means to control the entire production process of medical devices, reduce product risks, and ensure the safety and effectiveness of medical devices. It is also a basic content for evaluating the quality of medical devices. The quality level of medical device products largely depends on the improvement level of the company’s quality system. Therefore, building a reasonable, complete and effective medical device quality management system has become an important means for corporate compliance, health and sustainable development.