Jiangxi Proposes Categorization and Tiered Management System for "Two Products and One Device" with Four-Tier Supervision for Medical Device Manufacturers
The Jiangxi Provincial Drug Administration recently issued an announcement soliciting public comments on the Jiangxi Province "Two Products and One Device" Categorization and Tiered Management Measures (Trial) (Draft for Comments) (hereinafter referred to as the "Measures"). The feedback period ends on December 23, 2025.
The "Measures" propose implementing a classification and tiered management system for pharmaceutical production units, pharmaceutical distribution enterprises, medical device manufacturers, and cosmetic manufacturers within Jiangxi's administrative region, based on their risk level and quality management system rating.
Pharmaceutical production units and distribution enterprises will be categorized into Class I, II, and III, with Class I representing the highest risk.
Medical device manufacturers will be categorized into four tiers: Tier 4, Tier 3, Tier 2, and Tier 1 (Tier 4 likely representing the highest risk or complexity, based on common regulatory patterns).
Cosmetic manufacturers will be categorized into Class I and Class II.
Within the same category, enterprises' quality management systems will be graded from best to worst as Level A, B, C, and D. The Jiangxi Provincial Drug Administration will organize an annual quantitative assessment in January, scoring enterprises based on their previous year's quality management performance, starting from a baseline score of 100 points. Grading indicators will include changes in key personnel, training and education, supervision and inspection results, product quality, administrative penalties, consumer complaints and reports, safety incidents, and fulfillment of primary responsibility.
According to the "Measures," enterprises with different risk categories and quality management grades will be subject to differentiated inspection frequencies. Using medical device manufacturers as an example:
A Tier 4, Level A enterprise will, in principle, undergo no less than one full-scope inspection annually.
A Tier 4, Level D enterprise will, in principle, undergo no less than four inspections annually, including no less than one full-scope inspection.
According to earlier reports, on November 7, the Jiangxi Provincial Drug Administration solicited public comments on the Jiangxi Province Medical Device Distribution Supervision and Management Implementation Rules (Draft for Comments), which clarified access standards for medical device distributors regarding premises, personnel, etc. This new "Measures" integrates previously separate tiered supervision systems for pharmaceutical production, pharmaceutical distribution, medical device production, and cosmetic production, establishing a unified categorization and tiering framework for the "Two Products and One Device" within a single regulatory document.
Furthermore, the "Measures" state that during the trial period, if new national regulations are issued, they shall be followed. The existing regulations—Jiangxi Province Pharmaceutical Production Categorization and Tiered Management Measures (Trial), Jiangxi Province Pharmaceutical Wholesale (Retail Chain) Enterprise Quantitative Grading Supervision and Management Measures (Trial), Jiangxi Province Cosmetic Production Quality and Safety Risk Categorization and Grading (Trial), and Jiangxi Province Medical Device Production Tiered Supervision Implementation Measures—will be repealed simultaneously.
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