COVID-19: China Extends Quality Controls on the Export of Medical Products

The measures described in this article have since been adjusted by the Chinese authorities. Please refer to the following article for updates (Link).

 

On 31 March 2020, the Chinese Ministry of Commerce (MOFCOM), the General administration of Customs (GACC) and the National Medical Products Administration (NMPA) jointly declared that they would extend controls on the export of certain medical devices. The declared aim of the measure is to ensure product quality and safety when exporting medical products manufactured in China, which are in high demand worldwide in the wake of the corona pandemic.

According to the announcement, exporters of five types of medical devices must submit a written or electronic self-declaration at the time of customs declaration that the exported products are covered by a valid Chinese NMPA medical device approval certificate and that the exported products meet the quality standards requirements of the country. Customs authorities should verify the validity of the specified NMPA medical device approval certificate before releasing the goods for export. The measures will apply temporarily from April 1, 2020 and will be dynamically adjusted according to the further development of the global situation.

The measures adopted jointly by MOFCOM, GACC and NMPA cover the following five product groups:

 

#

Name

Name (CN)

1

COVID19 Test Kits

新型冠状病毒检测试剂

2

Medical masks

医用口罩

3

Medical protective clothing

医用防护服

4

Respirators

呼吸机

5

Infrared thermometers

红外体温计

The publication is accompanied by a template for manufacturers' self-declarations as well as a list of information on NMPA approval certificates valid at the time of publication (each with certificate number, product name and certificate holder for 23 corona test kits, 62 ventilators, 301 medical protective clothing, 1425 medical masks, 236 thermometer infrareds).

On April 10, 2020, GACC announced another new regulation: Effective immediately, Chinese customs authorities are conducting additional export inspections for eleven product groups of medical equipment to strengthen the quality control of exported products. The legal basis is the Law on Goods Inspection in Import and Export (last revised in 2018) and its applicable implementing regulations.

According to the annex to the announcement, the new GACC scheme applies to the following eleven product groups, further subdivided by HS codes:

#

Name (EN)

Name (CN)

HS-Code

1

Medical Masks

医用口罩

6307900010

2

Medical protective clothing

医用防护服

6210103010; 3926209000

3

Infrared thermometers

红外测温仪

9025199010

4

Respirators

呼吸机

9019200010; 9019200090

5

Medical headgear

医用手术帽

6505009900

6

Medical protective glasses

医用护目镜

9004909000

7

Medical gloves

医用手套

3926201100; 3926201900;

4015110000; 4015190000

8

Medical shoe protection

医用鞋套

6307900090; 3926909090; 4016999090

9

Patient monitors

病员监护仪

9018193010

10

Medical disinfecting wipes

医用消毒巾

3005901000; 3005909000

11

Medical disinfectant agents

医用消毒剂

3808940010

On 16 April 2020, the Chinese customs authorities provided comprehensive information on details of the implementation of the new measures during an official Q&A session.

It should be noted that the above-mentioned measures taken by the Chinese authorities apply exclusively to medical devices. Medical devices require pre-market approval in China, which can be verified by means of the NMPA approval certificate. Products classified as personal protective equipment (PPE), such as personal respirators according to Chinese standard GB2626-2006, are not covered by the above measures. However, PPE products are often exported under the same HS codes as similar product groups for medical use. Customs therefore point out that a clear declaration is necessary to avoid export delays for PPE products.

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