Notice Issued by the State: Key Monitoring of 131 Kinds of Medical Devices

Not long ago, the comprehensive Department of the NMPA released a message. The comprehensive Department of the NMPA publicly solicited Opinions on Strengthening the Hierarchical Supervision of the Production and Operation of Medical Devices (Exposure Draft).

The document points out that China’s current regulations on hierarchical supervision of production and operation were formulated in 2014 and 2015 respectively, and have not fully adapted to the new situation and requirements of supervision.

Therefore, in order to further implement the newly revised Regulations on the Supervision and Administration of Medical Devices , Measures for the Supervision and Administration of Medical Device Production, Measures for the Supervision and Administration of Medical Device Operation, and strengthen the supervision of medical device production and operation, the Department of Device Supervision of the NMPA is organizing the revision of the current regulations and form the Opinions on Strengthening the Graded Supervision of Medical Device Production and Operation (Draft for Comment) (hereinafter referred to as “Opinions”).

Undoubtedly, the change in the form of supervision means that the direction and frequency of the existing medical device flight inspection and routine inspection will change accordingly, affecting all medical device operators and manufacturers.

 Compared with the old version of the grading regulation, the new version of the Opinions (full text + key points attached at the end of the text) has made a series of changes.

First, the provisions on hierarchical supervision shall be revised into guidance. The Opinions points out that there will no longer be unified provisions on the classification of supervision levels, inspection frequency and coverage rate, but will provide guidance to local regulatory departments, highlighting the leading role of provincial drug regulatory departments and municipal drug regulatory departments divided into districts.

On the basis of finding out the industrial development and the allocation of regulatory resources, it is required to formulate detailed requirements for hierarchical supervision of production and operation in line with the actual supervision of the administrative region, and organize the implementation of hierarchical supervision of the production and operation of medical devices.

Secondly, the key regulatory catalogue of medical devices havebeen adjusted.

In the production process of medical devices, the provisions on the four-level supervision of the production enterprises of the national key regulated variety catalogue and the three-level supervision of the production enterprises of the provincial key regulated variety catalogue were deleted, and it has clarified that the provincial drug supervision and administration department should supplement the catalogue formulated by the NMPA according to the actual situation to form the key regulated catalogue of the administrative region, and divide the supervision level on this basis.

Products with mature production processes and relatively low risks such as staplers and hemostatic clips were deleted, and new high-risk products such as artificial liver equipment and cardiac arrest fluid appeared in recent years have been added.

In the business process of medical devices, the family planning products exempted from business filing have been deleted, the protective clothing and protective masks related to epidemic prevention and control have been removed from the sterile product category, and the protective product category have been set separately.

Products with high social concern and high traceability requirements, such as arteriovenous puncture devices, implantable auditory devices, rigid contact lenses, class III products in oral implants and tissue reconstruction materials were added, and products with low social concern and low usage, such as disposable non- electric driven infusion pumps and electric driven infusion pumps have been deleted.

Finally, the opinions have included 84 kinds of medical devices, such as hemodialysis equipment, contrast catheters and guide catheters, into the list of key supervised varieties of production; 47 kinds of medical devices, such as anesthesia puncture kits, blood bags and infusion sets, have been included in the list of key regulated varieties of medical device business.

 In addition, the Opinions also proposes that the principle of classification of supervision levels and inspection requirements for operating enterprises should be increased from three-level supervision to four-level supervision, and supervision and management should be scientifically strengthened.

The operating enterprises that “provide storage and transportation services for other medical device registrants, recorders and production and operation enterprises” and the key inspection enterprises determined through risk consultation shall be regarded as the enterprises with the highest risk level to implement four-level supervision. The drug supervision and administration departments at the municipal level divided into districts shall organize inspection at least twice a year, including no less than one inspection for the whole project.

For retail companies of corneal contact lenses and protective products, the frequency of inspections can be determined according to regulatory needs; the random sampling ratio of companies that implement first-level supervision will be increased from 30% to one-third.

A new requirement has been added for operating enterprises that have added warehouses in different places, and enterprises operating the products selected by the state’s centralized procurement of selected products and products for epidemic prevention and control.

It is noteworthy that the Opinions also introduces the concept of credit supervision.

The opinions clearly states that four levels of supervision shall be implemented on registrants, recorders and entrusted production enterprises with poor operation of the quality management system and serious bad credit records; The three-level supervision shall be implemented for the operating enterprises with administrative penalties or bad credit records in the previous year.

For enterprises with good quality management status and regulatory credit status for a long time, the regulatory level will also be lowered as appropriate.

If you need a key monitoring list of 131 kinds，pls feel free to reach out to us  via info@bradyknowsmedical.com