Production risk grading supervision released, machinery enterprises should also pay attention to device market

On October 26, 2023, the Yunnan Provincial Drug Administration issued the “Implementation Rules for the Grading Supervision of Medical Device Production Risk in Yunnan Province (Trial)(hereinafter referred to as the Rules). In response to the development characteristics of the medical device industry in the province, and in combination with the relevant requirements of the NMPA and the Provincial Market Supervision Bureau, the Rules were formulated to further strengthen the effective identification, scientific prevention and control, and precise governance of risks.

#01 Details

The Detailed rules consist of four chapters, 23 articles and 1 schedule. The main content is divided into four parts: general provisions, risk classification, supervision requirements and supplementary provisions. Among them:

Chapter 1 General Provisions, totaling 5 articles. It clarifies the legal basis, scope of application, and job responsibilities of the Detailed Rules. At the institutional level, it clarifies the basic definition of hierarchical supervision of medical device production and the basic principles that should be followed.

Chapter 2 Risk Levels, totaling 10 items. It specifies the risk assessment indicators, scores, scoring methods, and risk levels for medical device manufacturing enterprises.

Chapter 3 Supervision Requirements, consisting of 5 articles. It clarifies the regulatory forms and principles adopted by drug regulatory authorities, and different risk levels correspond to different regulatory measures.

Chapter IV, Bylaws, consisting of three articles. It explains relevant terms and limits the period of validity of the Rules.

Attached table: Setting the initial static risk scores for different types of medical device production enterprises. The details are as follows:

Note: Enterprises that simultaneously produce two or more items listed in serial number 1, 2 and 3 in the above table shall be scored according to the highest score

#02 Six principles of hierarchical supervision

On September 7, 2022, NMPA issued the guidance of NMPA General Division on strengthening graded supervision over the production and operation of medical devices. In accordance with the principle of “risk classification, scientific supervision, comprehensive coverage, dynamic adjustment, implementation of responsibility and improvement of efficiency”, carry out graded supervision over the production and operation of medical devices, consolidate the regulatory responsibilities of drug regulatory departments at all levels, establish and improve a scientific and efficient supervision mode, strengthen the supervision and management of the production and operation of medical devices, and issue the catalogue of key supervision varieties for the production of medical devices and the key supervision varieties for the operation of medical devices.

The implementation of four levels of supervision of enterprises with a high degree of risk, mainly including the production of key regulatory species catalogue products in the administrative region, as well as the operation of the quality management system, etc., and the implementation of three levels, two levels and one level of supervision of enterprises with a lower degree of risk.

In addition, MPA at all levels should formulate a catalogue of key supervised varieties of medical device production in its administrative region according to the actual situation, and supplement and dynamically adjust it according to the catalogue formulated by the NMPA

On the basis of the requirements of NMPA, the  Rules take full account of the actual situation in Yunnan, and innovatively propose a dynamic and static risk assessment index, a comprehensive quantitative scoring model, and scientifically and efficiently establish a risk assessment system and regulatory system for medical device manufacturers, so that enterprises can clearly know their own problems and corresponding regulatory requirements. Improving the operability of hierarchical supervision is conducive to giving full play to the efficiency of regulatory resources and promoting the implementation of corporate security main responsibility awareness.

#03 Various regions have responded and implemented supervision according to local conditions

On July 18, 2023, the Chengdu Market Supervision Administration issued the Notice of the Chengdu Market Supervision Administration on the Issuance of the Implementation of the Hierarchical Supervision of Medical Device Production and Operation in Chengdu, which made provisions in four aspects: the implementation of the hierarchical supervision responsibilities, the elaboration of the hierarchical supervision rules, the precise division of supervision levels, and the formulation of the frequency and coverage rate of supervision and inspection.

On March 7, 2023, the MPA of Jiangsu Province issued a notice on the issuance of the Implementation Measures for Graded Supervision of Medical Device Production in Jiangsu Province (Effective), which stipulates that enterprises under fourth level supervision shall organize at least one full project inspection every year; Third level regulatory enterprises shall organize inspections at least once a year; Secondary regulatory enterprises shall conduct inspections at least once every two years; Primary regulatory enterprises randomly select more than 25% of their administrative regions each year for supervision and inspection.

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Source：Saibolan Device

Translated & edited ： Bradyknow