On March 1, 2023 in China, the Rules established by the National Medical Products Administration (NMPA) and the Center for Medical Device Evaluation (CMDE) have become fully implemented, as per Measure No 124 Published in late 2022: Regulations on the supervision and administration of enterprises implementing the main responsibility for the quality and safety of Medical Devices.
The Regulation aims to protect the quality and safety of Medical Devices placed on the market in China.
To whom is the measure of the Quality and Safety of Devices addressed?
The measure applies to all Organisations and Personnel with direct responsibility for the product placed on the market in the territory, i.e. Chinese Manufacturers or delegates (Legal Agents, Licensees and Applicants) and their foreign manufacturers, in the case of Manufacturers based outside China.
The measure is divided into 6 chapters and 30 articles, some of the most significant elements of which are listed below:
- Requirements for key positions of Quality and Safety of the Device.
For production companies, key positions include the Legal Representative or General Manager, the Management Representative for Quality and the Quality Management System Manager. For operational organisations, on the other hand (e.g. Legal Agent), key personnel include the Legal Representative or General Manager, the Quality Management Representative and the Quality Management System Manager.
- Qualifications of Quality Management Personnel. Personnel involved in Quality Management should have specific technical training and experience, including laboratory science, biomedical engineering, immunology, biochemistry, genetics, pharmacy, biotechnology or clinical medicine.
- Auditing of outsourced production. Audits at the manufacturer must be organised regularly to ensure that the quality management systems between Manufacturer and Supplier/Legal Agent are effectively connected. The outsourced manufacturing company must be available to take corrective action in the event of reports or non-compliance. In addition, the production manager of the outsourced company must send at least quarterly a report to the Management Representative or Management showing data and information about the production process and the application of controlled process management, risk control actions and production planning activities.
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