At present, global disease of the epidemic COVID-19 surveillance and control is faced with a serious challenge. The spread of the COVID-19 virus have exploded, foreign demand for masks and other medical supplies increased from China.
While the world is gripped by the fight against COVID-19, some suppliers have turned this into an opportunity to earn money in no-conforma mask. There have been a disturbing number of reports citing seizures of fake medical supplies, such as face masks, Medical Equipments and hand Sanitizers, specifically.
China Official Announcement of exporting reagents for detection of the novel coronavirus
In order to effectively support the global fight against the epidemic COVID-19, to ensure product quality and safety, and to standardize the sequence of exports during this special period of epidemic prevention and control, China Ministry of Commerce and China Customs released announcement on March 31, 2020, which the Chinese enterprises exporting reagents for detection of the novel coronavirus, medical masks, medical protective clothing, ventilators, and infrared thermometers must provide written or electronic declarations (see Attachment 1 for the template) promising that the exported products have obtained China’s medical device product registration certificates (see Attachment 2 for relevant registration information) and meet the quality standard requirements of importing countries (regions). Customs shall rely on medical device product registration certificates approved by the drug supervision and administration departments in processing. The aforementioned quality control measures for the export of medical materials will be dynamically adjusted in light of the developing epidemic situation.
Relevant enterprises exporting medical materials should ensure the quality and safety of their products and that they meet the requirements of relevant standards, to actively support the international community in fighting the epidemic together.
How to verify the Chinese trading company?
The Chinese trading company need the import and export License. If the trading company is exporting non-medical materials such as ordinary masks, you can import directly without regulatory conditions.
If the trading company is exporting medical apparatus such as surgical masks, you need to ask the trading company to provide these materials: Product registration certificate, Registration form and accessories, Manufacturer’s business license, Second class medical device record, Medical device production license, Production registration form, Authorization letter, note that the authorization letter indicates that the manufacturer provides after-sales service.
Second class medical device record
Medical device production license
If you want to register a export – import company in China, you can read this article. 6 steps to set up trading company in China.
If you want to search the China Trademark of the manufacturer’s products, you can visit the Website Registrationchina.com to get the latest Information.
China Medical Device Classes:
In China, all the medical devices enterprises are divided into three classes by the China National Medical Products Administration （NMPA）. This is the website of Food and Drugs Regulatory information platform : http://www.cfdacx.com/
Low-risk medical devices whose safety and effectiveness are ensured through routine administration.
Mid-risk medical devices that require further control in order to ensure their safety and effectiveness.
High-risk medical devices that are implanted into the human body, used to support or sustain life, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.
China medical device classification categories:
01 surgical instruments with electronics (active)
02 surgical instruments without electronics (passive)
03 nerve and vascular surgical instruments
04 orthopedic surgery-related devices
05 radiation therapy equipment
06 medical imaging equipment
07 medical examination and monitoring equipment
08 respiratory, anesthesia and first-aid equipment.
09 physical therapy equipment
10 blood transfusion, dialysis and cardiopulmonary bypass equipment
11 medical equipment disinfection and sterilization equipment
12 active implant devices
13 passive implant devices
14 infusion, care and protective equipment
15 patient-carrying devices
16 ophthalmic devices
17 dental instruments
18 obstetrics and Gynecology, reproductive and contraceptive devices
19 medical rehabilitation devices
20 Chinese medicine instruments
21 medical software
22 clinical testing devices
How to identify the qualification of medical apparatus in China?
You should go to the official website of “National Medical Products Administration” and then click on the column of “medical devices” – “domestic devices”. According to the instructions on the page, enter the medical device registration certificate number or enterprise name of this mask, you can know the production information related to the product, the approval number information, you can know whether qualified.
What certification is required for masks exported to European and American countries?
Masks exported to the European Union need to obtain CE certification, and masks exported to the United States need to pass FDA certification. However, recently, the United States suddenly canceled the recognition of Chinese KN95 mask standards. For details, please refer to the link to the FDA website at the bottom of this article.