2024 IVD Reagents Clinical Trial Exemption Catalog in China – Draft for Comments

2024 IVD Reagents Clinical Trial Exemption Catalog draft has been announced by the Center for Medical Device Evaluation (CMDE) on November 4, 2024, and opened for public consultation. This initiative is part of China's ongoing effort to streamline regulatory requirements, reduce the burden on manufacturers, and foster innovation in the medical device and in vitro diagnostic (IVD) sectors.The consultation process provides a crucial opportunity for stakeholders to offer their input and help shape the future of clinical trial exemptions for IVD reagents in China.

Context and Objectives

This update aligns with the Opinions on Deepening the Reform of the Evaluation and Approval Systems and Encouraging Innovation on Drugs and Medical Devices (Office [2017] No. 42). These opinions emphasize the need for a robust yet flexible regulatory framework that supports innovation while ensuring patient safety.One of the key outcomes of this reform has been the creation of a catalog of IVD reagents exempted from clinical trials. The exemption catalog lists products for which clinical trials are not mandatory due to their established safety and efficacy profiles. For 2024, the CMDE aims to expand this catalog, reflecting advancements in diagnostic technology and increasing clinical demand.By doing so, they seek to reduce regulatory barriers, accelerate market access for innovative products, and address pressing public health needs.

Key Updates in the 2024 Draft

The 2024 draft includes several noteworthy additions to the exemption catalog:Level 1 Serial NumberTier 1 Product CategoriesLevel 2 Serial NumberSecondary Product Category (Product Name)Intended UseManagement Category08Reagents for Protein Detection08090Gastrin 17 (G-17) Test ReagentFor the detection of gastrin 17 (G-17) in human samples. Used clinically as an aid in the diagnosis of atrophic gastritis.Ⅱ08Reagents for Protein Detection08031Calcineurin Test ReagentFor the detection of calprotectin levels in human feces. Used clinically as an aid in the diagnosis of inflammatory diseases of the intestinal tract.Ⅱ08Reagents for Protein Detection08034High sensitivity troponin I testFor the detection of Troponin I levels in human samples. It is used clinically as an aid in the diagnosis of myocardial infarction and for risk stratification, therapeutic monitoring, and prognostic evaluation of patients with acute coronary syndromes.Ⅱ08Reagents for Protein Detection08035High sensitivity troponin T testFor the detection of Troponin T levels in human samples. It is used clinically as an aid in the diagnosis of myocardial infarction and for risk-stratified therapeutic monitoring of patients with acute coronary syndromes, as well as for prognostic assessment.Ⅱ18Reagents for the Detection of Allergic Reactions (Allergens)18001Total IgE Test ReagentFor the detection of Immunoglobulin E (IgE) in human samples. Used clinically as an aid in the diagnosis of allergic reaction states in humans.Ⅱ19Reagents for Other Physiological, Biochemical or Immune Function Tests19035Absolute Counting Microsphere ReagentUsed to measure the percent and absolute counts of lymphocytes, lymphocyte subsets, and CD34+ cell populations in human blood samples. It is used clinically for the enumeration of T-lymphocyte subsets.Ⅱ

Invitation for Feedback

The CMDE is inviting feedback from industry stakeholders, including manufacturers, regulatory professionals, and clinical experts. This consultation process is an opportunity to propose revisions, suggest new products, or provide justifications for changes to the catalog. Feedback can be provided in the following categories:

Proposed Additions: New products to be included in the draft catalog.
Revisions: Changes to the products listed in the 2024 draft.
Updates to the 2021 Catalog: Revisions to products included in the previously published exemption catalog.

Comments can address serial numbers, product categories, intended uses, and regulatory classifications.Stakeholders are encouraged to use the feedback form provided in Appendix and submit responses via email to huangyl@cmde.org.cn by December 3, 2024. The subject line should read: “Feedback on the 2024 Exemption Catalog of In Vitro Diagnostic Reagents.”

Why This Matters

Expanding the exemption catalog benefits the medical device industry and healthcare systems by reducing the time and resources required to bring diagnostic products to market. For manufacturers, the exemption reduces the cost of compliance, enabling faster commercialization of innovative products. For healthcare providers and patients, it ensures quicker access to critical diagnostic tools.