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Regulatory Requirements and Standards for Coronavirus Reagent Test Kits and Protective Equipment in China

Updated: 2020-03-30

I. Requirements for registration of coronavirus reagent test kits 

China classifies medical devices including in vitro diagnostic reagents into three categories according to risk levels. Class I has the lowest level of risk and Class III has the highest. Coronavirus reagent test kits are classified as Class III medical devices.

Enterprises applying for registration of coronavirus reagent test kits must submit the following materials:

1. Application forms;

2. Qualification documents;

3. General materials;

4. Research materials for major raw materials;

5. Research materials for major production techniques and reaction systems;

6. Evaluation materials of performance analysis;

7. Materials for determination of positive value or reference range determination; 

8. Stability research materials;

9. Production and self-testing records;

10. Clinical evaluation materials;

11. Materials on analysis of product risks;

12. Technical requirements of products;

13. Product registration and testing reports;

14. Product instructions;

15. Labeling samples;

16. Declaration of conformity.

In response to the coronavirus epidemic, the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) has formulated the Technical Key Points for Coronavirus (COVID-19) Nucleic Acid Reagent Test Kit Registration Review and the Technical Key Points for Coronavirus (COVID-19) Antigen-antibody Detection Reagent Registration Review (Trial). The documents were prepared to guide enterprises in registration application.

As of March 30, 2020, the NMPA had approved 23 coronavirus test kits in response to the emergency, including 15 nucleic acid reagent test kits and 8 antibody test kits.

II. Regulatory requirements for protective equipment

The NMPA has issued guidelines for technical review of products related to epidemic prevention and control including medical face masks, single-use surgical gowns and single-use surgical packs.

III. Standards for protective equipment 

China has formulated and issued the following standards for medical protective clothing and medical face masks: GB19082-2009 Technical Requirements for Single-use Protective Clothing for Medical Use, GB19083-2010 Technical Requirements for Protective Face Masks for Medical Use, YY/T0969-2013 Single-use Medical Face Mask and YY0469-2011 Surgical Masks.

IV. Enhance regulation of medical protective equipment (masks, protective clothing, goggles and face shields)

Medical masks and protective clothing are regulated according to the standards for Class II medical devices in China. According to relevant sections of China's Regulations for the Supervision and Administration of Medical Devices and the Provisions for the Supervision and Administration of Medical Device Manufacturing, a manufacturing enterprise must obtain production licenses issued by a provincial drug regulatory department before production. 

Goggles and face shields are regulated according to the standards for Class I medical devices in China. A manufacturing enterprise must file the records with a drug regulatory department at districted city level before production. 

Manufacturing enterprises must establish a quality management system for medical products and