China Publishes Guidance for Medical Device Good Manufacturing Practice On-Site Inspections on Standalone Software

On 29 May 2020, the National Medical Products Administration ( NMPA) of China has formulated a  “Guiding Principles for On-site Inspection of Independent Software for Medical Device Production Quality Management Standards”  to ensure compliance of GMP by the medical device manufacturers.

The guiding document serves to strengthen the supervision and inspection of the implementation of the “Medical Device Production Quality Management Standards” and its appendix independent software for medical device manufacturers.

The guideline advocates that regulatory agencies and medical device manufacturers shall adapt to the organization chart and responsibilities of each department and the quality management function should be clarified.
The production aspect is also covered in the guideline where the manufacturers are required to check the company’s quality manual, procedure documents, or related documents.  Further,  the personnel engaged in work affecting product quality should undergo training appropriate to their job requirements and have relevant theoretical knowledge and practical operational skills.

The person in charge of the enterprise shall be the main person responsible for the quality of medical device products and l organize the formulation of quality policies and quality objectives.

The guideline further dwells into establishment and facilities; equipment and devices; documentation and records management,  design and development,  purchase, sales and after-sales service, nonconforming product control, adverse event surveillance and assessment, and improvement.

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