The NMPA issued the “Guideline on Inspection of Quality Management System for Medical Device Registration” on October 10, 2022, implementing from the day of release.
Product Life-cycle Process
The guideline stipulates the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. The applicant should establish QMS that is compatible with the entire product life-cycle process:
- Ensure that the design, development, production, and other process data are true, accurate, complete, and traceable, and consistent with the registration application materials
- The registration QMS inspection should be organized in reference to the registration application materials, focusing on the design, development, procurement, production management, quality control, etc.
- For the submission of self-inspection report, the applicant’s QMS and ability shall be reviewed in accordance with the “Regulations of Self-testing for Medical Device Registration” and in reference to the product technical requirements (PTRs).
- For applicants who entrust other enterprises in design and development, product production, etc., the scope of inspection shall cover entrusted R&D and production activities. When necessary, extended inspections shall be carried out on other units that provide products or services for medical device R&D and production.
Key Areas for NMPA Quality Management System
The guideline clarifies the key contents for the on-site inspection of the QMS:
- institutions and personnel
- facilities and equipment
- document management
- design and development
- procurement, production
- quality control
- commissioned production
For example, if the production is commissioned, the guideline asks applicant specifies the department and personnel responsible for guiding and supervising the QMS of the entrusted enterprise, and in principle, a manager representative should be designated to be responsible for the quality management of the entrusted production.
Device Categories in Design Process
The guideline emphasizes QMS in the design process. It specifies the requirements for each device category:
Non-active medical devices
The raw material components of non-active medical devices shall meet the requirements of relevant standards, and the biocompatibility evaluation shall be completed for the parts in contact with the human body. When reusable sterile products are re-sterilized, the performance of the finished product should be evaluated, and a tolerability re-sterilization study should be completed.
Active medical devices
Active medical devices should complete relevant researches according to the standard requirements, such as electric shock hazard protection, mechanical hazard protection, radiation hazard protection, over-temperature hazard protection, electromagnetic compatibility, biocompatibility, etc.
Animal source medical devices
Animal-derived medical devices should complete research on animal species (if the risk is related to the strain, the strain needs to be specified), geographic origin (for species whose geographic origin cannot be determined, provide source animal survival period identification and traceability requirements), age (applicable when relevant to risk, e.g. susceptibility of animals to naturally occurring transmissible spongiform encephalopathy), type of sample site and tissue, animal and tissue health status, verification on virus inactivation method, etc.
The main raw materials, intermediates, important excipients, etc. involved in the research process of in vitro diagnostic reagents shall have clear sources and meet the requirements, and the equipment, instruments and reagents used in the research process shall meet the research requirements.
The guideline also specifies 73 inspection items in the attached table as annex. The on-site inspection conclusion has four circumstances: pass the inspection, fail the inspection, pass the inspection after rectification, and fail the inspection after rectification.
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