Monthly Recap: China Pharmaceutical Regulatory Updates | Oct. 2021

by Grace Wang Nov 11, 2021

Editor's Note: Monthly recap is a brief collection of recently-issued drug laws, regulations and policies in China, especially those issued by the following authorities:

  • National Medical Products Administration (NMPA);

  • NMPA's Center for Drug Evaluation (CDE);

  • National Health Commission (NHC);

  • National Healthcare Security Administration (NHSA).

China's Pharma Regulatory Dynamics in Oct. 2021

  1. NMPA Releases IVD Reagent Classification Rules

  2. NMPA Greenlights 195 Medical Devices

  3. NMPA Publishes Medical Device's Self-Test Rules

  4. NMPA Rolls Out the 45th, 46th, and 47th Batches of Reference Listed Drugs

  5. NHC Consults on Detailed Rules on the Supervision of Internet-based Diagnosis

  6. CDE Releases Pharmaceutical Guidelines

1. IVD Reagent Classification Rules

On Oct. 29, NMPA released the In Vitro Reagent Classification Rules1 with immediate effect. The Rules only applies to the IVD reagents regulated as medical devices. IVD reagents intended for blood screening and IVD reagents labeled by radionuclide are not subject to the Rules.

IVD reagent are divided into three classes based on risk levels:

IVD Reagent Classification in China

Source: In Vitro Reagent Classification Rules effective since Oct. 29, 2021

Relevant regulation: IVD Reagent Registration and Filing in China effective since Oct. 1, 2021

Class I

Low risk

1. Microbiological culture medium NOT for identifying microbes or testing drug allergies;

Cell culture medium ONLY for culturing microbes WITHOUT functions of selecting, inducing and differentiating cells, and the cultured microbes are for in vitro diagnosis.

2. Products for processing samples, e.g., hemolysis reagents, dilution solutions, stain solutions, nucleic acid extraction reagents.

3. General reagents for the reaction system, e.g., buffer solution, substrate solution.

Class II 

Moderate risk

IVD reagents, except for the Class I and Class III ones, are defined as Class II products, which mainly includes the following products:

1. Reagents for testing proteins;

2. Reagents for testing saccharide;

3. Reagents for testing hormones;

4. Reagents for testing enzymes;

5. Reagents for testing esters;

6. Reagents for testing vitamins;

7. Regents for testing inorganic ions;

8. Reagents for testing drugs and drug metabolites;

9. Reagents for testing autoantibodies;

10. Reagents for identifying microbes or testing drug allergies; cell culture medium for identifying microbes, with functions of selecting, inducing and differentiating cells, and the cultured microbes are for in vitro diagnosis;

11. Reagents for testing allergic reactions (allergens);

12. Reagents for testing other physiological, biochemical and immune function indicators.

Class III

High risk

1. Reagents for testing pathogenic antigens, antibodies and nucleic acids;

2. Reagents relevant to blood matching and tissue typing;

3. Reagents relevant to human genetic testing;

4. Reagents relevant to hereditary diseases;

5. Reagents relevant to testing anesthetic, psychiatric drugs and toxic drugs for medical use;

6. Reagents relevant to testing the targets of therapeutic drugs; companion diagnostics (CDx);

   *CDx are tools for evaluating the safety and effectiveness of corresponding medical products. CDx are mainly used before and/or during treatment. They identify patients who are most likely to benefit from the corresponding medical product or at increased risk of severe adverse reactions as the result of treatment with the corresponding medical product.

7. Reagents relevant to cancer screening, diagnosis, companion diagnostics, staging, etc.

2. NMPA Greenlights 195 Medical Devices

On Oct. 18, NMPA released the list of newly-approved 195 medical devices. 26 of them are imported Class III high-risk medical devices, including Sorin Group Italia S.r.l.'s Accessories for the Perceval Sutureless Aortic Heart Valve and Roche's Global Cal.

36 approved medical devices are imported as Class II moderate-risk products, including Abbott's Magnesium Assay Kit (enzymatic method) and HS HOSPITAL SERVICE S.p.A.'s Coaxial Biopsy Needle.

Relevant regulation: Medical Device Registration and Filing in China.

3. Administrative Rules on Self-Test of Medical Devices

NMPA now allows Chinese and international companies to conduct self-tests for medical devices, says the Administrative Rules on Self-Test of Medical Devices which took effect on Oct. 2021.3

On the one hand, the Rules brings flexibility. Besides designated Chinese labs, companies can choose one of the following methods to do self-tests:

Grace Wang
ChemLinked Regulatory Analyst
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