Regulatory Open Forum

NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.

Product Life-cycle Process

The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. The applicant should establish QMS to align with the entire product life-cycle process. Applicant needs to:

1. ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
2. carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
3. Review the applicant's QMS in accordance with the "Regulations of Self-testing for Medical Device Registration" and the product technical requirements (PTRs) when submit self-testing report.
4. Inspect commissioned R&D and production activities for commission situations in design and development, production, etc., the scope of inspection with entrusted enterprises. Also inspect institutions that provide products and services relevant to medical device R&D and production if necessary.

Device Categories in Design Process

The guideline emphasizes QMS inspection principles for IVDs and device categories in non-active, active, and animal source in design process:

 

Non-active medical devices

The raw material components of non-active medical devices shall comply with 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 research 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.

 

Key areas to pay attention

1. The guideline made specifications for on-site inspection:
   • Inspection needs to cover at least institutions and personnel, facilities and equipment, document management, design and development, procurement, production, quality control, commissioned production, and authenticity.
   • On-site inspection results determination principles include:
     1. Pass
     2. Fail
     3. Pass after correction
     4. Fail after correction

2. For the commissioned production, the guideline asks applicant to specify the department and personnel that is responsible for guiding and supervising the production process, in principle, a manager's representative will be designated.

 

Please refer to the guideline for complete information. This is another major regulation update following the State Order 739 at the law level emphasizing complete product life cycle. Love to hear your feedback and challenges, please feel free to comment or email me at gpalma@ChinaMedDevice.com

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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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