In July 2023, the National Medical Products Administration (NMPA) issued the Opinions to further emphasize the significance of classification management in overseeing medical devices. As the medical device industry advances rapidly, regulatory efforts face new challenges and demands.
According to the Opinions, the future endeavors will focus on optimizing organizational classification and management systems, refining classification and management protocols, boosting operational efficiency, enhancing capacity, elevating service standards, and bolstering supervision and implementation oversight.
As of August 1, 2018, a revised version of the Classification Catalogue for Medical Devices took effect, showcasing notable improvements compared to the previous one:
1. Structural Enhancements
- The new catalogue features a more scientifically structured format, aligning closely with clinical application.
- It consolidates and streamlines the original 43 subdirectories into 22, refining 260 product categories into 206 primary categories and 1,157 secondary categories, forming a comprehensive three-tier directory hierarchy.
- Notably, the directory's capacity is expanded tenfold, from1,008 to 6,609 typical product name examples.
2. Expanded Content
- Over 2,000 additional items of intended use and product description have been incorporated into the new catalogue.
- This detailed expansion covers a broader spectrum, offering more comprehensive guidance and operational clarity, fostering consistency and standardization in registration and approval processes.
3. Dynamic Adjustment Mechanism
- A novel feature of the revised catalogue is its dynamic adjustment mechanism.
- This mechanism facilitates effective updates to the catalogue, optimizing the allocation of regulatory resources and ensuring ongoing relevance and applicability.
As per the Regulation on the Supervision and Administration of Medical Devices, the Drug Administration under the State Council is tasked with formulating and modifying classification rules and catalogues for medical devices.
These adjustments align with evolving production, operational, and utilization landscapes of medical devices, alongside timely analysis and evaluation of associated risks. Such adjustments may entail:
- Modifying subdirectories.
- Adjusting primary and secondary product categories, as well as management categories.
- Introducing representative and breakthrough medical devices.
- Removing products no longer classified as medical devices.
- Revising product descriptions, intended uses, and product name examples.
On December 31, 2020, NMPA issued public notices to modify the Catalogue, encompassing adjustments for 28 medical devices.
On March 24, 2022, NMPA issued public notices to modify 10 types of medical devices.
Further adjustments were made on March 30, 2022, by NMPA, refining product descriptions, intended uses, examples of product names, and management categories for 27 medical devices. Additionally, new secondary categories were introduced.
On August 17, 2023, NMPA issued an announcement to revise specific sections of the Catalogue, affecting 15 subdivisions and a total of 58 items.
Medical device classification is not static. It evolves based on usage safety risks. NMPA regularly updates the Catalogue in line with industry advancements and supervisory needs.
This ongoing process enhances product management categories, refines product descriptions and intended uses, and expands the range of catalogue examples. Such measures effectively address industry challenges related to product classification definitions, significantly bolstering the comprehensive management of medical device classification in China.
In April, the recent release of the 2024 medical device classification encompasses 223 results, including 93 products related to In Vitro Diagnostics (IVD). Among these, 27 IVD-related products are suggested for Class III medical device management, 45 for Class II, and 14 for Class I.
