CFDA exempts registration of medical devices for novel coronavirus (Wuhan pneumonia) epidemic prevention & control products

In order to help fight against the spread of the novel coronavirus (Wuhan pneumonia) epidemic in China,  China's National Medical Product Administration (former CFDA) issued the "Opinions on Emergency Import of Medical Devices Not Registered in China" on January 17, 2020;It allowing the novel coronavirus epidemic prevention and control products (imported medicines, medical devices and other materials), can be exempted from routine CFDA registration procedure, emergency imported into China,

The local FDA will issues a temporary import certificate for such anti-epidemic medical products, then the importer can apply a rapid customs clearance process through the green channel of the local Customs.



1.The novel coronavirus epidemic prevention and control medical products listed on the CFDA-exempt list include:

(1) The medicines mainly include:

a-interferon, HS code: 3002.1500,

Clenage (lopinavir / ritonavir), HS code: 3004.9090,

Methylprednisolone, HS code: 3004.3200,

etc.

(2) Medical devices & IVD mainly include:

Medical Surgery Mask(N95), HS code: 6307.9000,

Protective mask, HS code: 3926.9090,

Protective goggles, HS code: 9004.9090,

Protective face shield

Medical chemical fiber protective clothing (Isolation gown), HS code: 6210.1030,

Medical disposable latex gloves, HS code: 4015.1900,

Medical shoe cover,

Surgical hat,

Comphrehensive respiratory protective device

Mercury thermometer, HS code: 9025.1100,

Infrared thermometer, HS code: 9025.1990,

Nucleic acid extraction reagent

Testing kit for novel coronaviruses

etc.

(3) Disinfectant products mainly include:

Disposable hand sanitizer, HS code: 3808.9400,

Fast-dry hand disinfectant（contains mainly hydrogen peroxide）

Anti-bacteria hand sanitizer

Medical bactericides in non-retail packaging, HS code: 3808.9290,

Ordinary cleaning wet wipes with organic surfactant, HS code: 3401.1990,

84 Disinfectant

Effervescent tablets of chlorine dioxide

Sterilizer equipments

Disinfectant sprayer

Etc



2. The main documentation requirements for the overseas Medical devices manufacturer or exporter:

(1) Provide Medical device Listing certificate to prove it has legal marketed in the country of origin.

(2) Provide Medical device testing reports to prove its compliance with the relevant standards of the United States, the European Union and Japan;

(3) Product's Chinese labeling, manual;

etc;