What preparations should medical device companies do to implement registration self-inspection

The newly revised Regulations on the Supervision and Administration of Medical Devices stipulates that the product inspection report submitted during medical device registration can be the self-inspection report of the medical device registration applicant or filer, or the inspection issued by a qualified medical device inspection agency. Report. This is the first time that China has allowed medical device registration applicants or filers to submit self-inspection reports for medical device product registration at the level of national regulations.

On October 21, 2021, NMPA has issued the Regulations on the Administration of Self-inspection of Medical Device Registration, which stipulates requirements for self-inspection capability, self-inspection report, commissioned inspection, application materials, on-site inspection and responsibility requirements.

So far, China’s medical device registration and self- inspection has laws and justifications, and medical device enterprises usher in a new environment for submitting self inspection reports for registration.

Advantages and risks of enterprises carrying out registration self- inspection

After switching to self- inspection, the enterprise can allocate internal resources according to the established priority, which can greatly shorten the detection cycle of key projects.

After switching to self- inspection, the technical ability of medical device enterprises may have limitations compared with qualified medical device inspection institutions. Therefore, it is necessary to control the quality risks related to the safety and effectiveness of self -inspection products.

Attention should be paid to the establishment of inspection related management requirements

To carry out self- inspection, the registration applicant needs to have self -inspection ability and be equipped with inspection equipment and facilities suitable for product inspection requirements.

Specific requirements for the management of inspectors, test samples, equipment and environment, test quality and test records are put forward in the Regulations on the Administration of Self -inspection of Medical Device registration. These requirements do not exceed the requirements of CNAS-CL01 Accreditation Criteria for Testing and Calibration Laboratories (ISO / IEC17025). Therefore, they are also explained in the Regulations on the Administration of Self- inspection of Medical Device Registration, If the laboratory carrying out self- inspection is approved by China National Accreditation Service for conformity assessment (CNAs), it may not need to submit part of the data when submitting the application data, but only need to provide the supporting documents of the corresponding approval and the supporting data of the corresponding inspection scope.

If the laboratories of medical device enterprises have been recognized by China National Accreditation Service for conformity assessment (CNAs), the management of inspection related elements can meet the requirements of the regulations on the administration of self -inspection of medical device registration. The implementation of self- inspection is more to consider the differential requirements of self- inspection and other tests. On the one hand, it is necessary to consider the differences between the document form issued by the laboratory before the self -inspection and the registered self -inspection report, and revise the relevant document record template. On the other hand, due to the characteristics of registration self- inspection, such as inspection of technical requirements and possible coverage of multiple models, which may be different from the previous laboratory inspection, it is necessary to consider the special work guide for self -inspection. If necessary, relevant work instructions for important work such as inspection access, inspection process control and inspection report output can be provided,inorder to guide the self -·inspection. If the laboratory of a medical device enterprise has not considered or has not been recognized by the China National Accreditation Service for conformity assessment (CNAs) before, and carries out self -inspection in accordance with the requirements of the regulations on the administration of self -inspection of medical device registration, it is necessary to sort out the relevant management requirements of inspection, promote the improvement of the enterprise’s laboratory management system and improve the management level and technical ability, so as to enhance the overall competitiveness of enterprises.

Establish the process of registration and self-inspection quality management system

The implementation of self-inspection also puts forward new requirements for the quality management system of medical device enterprises.

First of all, enterprises need to interpret the requirements of the Regulations on the Management of Medical Device Registration Self-inspection， and establish a quality management system process related to registration and self-inspection accordingly. At the level of process enforceability, regulations define only basic requirements. Enterprises also need to plan the corresponding business processes, responsibilities and node deliverables based on the characteristics of their own registration and self-inspection business, and establish and plan to adapt to the self-inspection business flow. process/record template.

Secondly, the authenticity of registered inspection samples is an important concern throughout the whole process of enterprise self- inspection.
Thirdly, we need to take seriously the unqualified products and change management found in the registration self-inspection process. For unqualified products, it is necessary to follow the corresponding unqualified record process and keep the corresponding unqualified records. Whether the change is caused by nonconformity or active change, the corresponding change process shall be followed.

Author：Shenzhen Mindray

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