China Enhancing Quality Oversight for Exported Epidemic Prevention and Control Supplies
On April 27, 2020, an Announcement No.12 (2020) of the Ministry of Commerce, the General Administration of Customs, and the State Administration for Market Regulation was released on further enhancing quality oversight for exported epidemic prevention and control supplies. Measures to enhance quality oversight and step up export regulation for epidemic prevention and control supplies are emphasized in this announcement. In the aspect of enhancing quality oversight for exported non-surgical face masks, as of April 26, 2020, exported non-medical use face masks shall conform with the quality standards of China or other countries; meanwhile, as for stepping up export regulation for medical supplies, as of April 26, 2020, exporting companies of SARS-CoV-2 testing reagents, medical face masks, medical protective suits, ventilators and infrared thermometers that have obtained certification or authorization from other countries shall submit a declaration in writing. This declaration shall be submitted with customs declarations, as a warranty that the products are compliant with the quality standards and safety requirements of the importing countries (regions).
On April 27, 2020, CMDE also released some of the most confusing issues about exports to the EU and the US. More details will be elaborated in the table below.
| Issue | Explanation | |
| EU | CE (European Conformity) marking | According to PPE and MDD/MDR requirements, CE marking shall be found on products exported to the EU. |
| CE certificate | In accordance with the requirements of PPE and MDD/MDR, PPE or medical devices shall be evaluated by an EU approved NB (Notified Body) and the CE certificate with NB number is issued by the NB. | |
| Requirements applied for epidemic prevention products | Masks are divided into surgical masks and personal protective masks, which are managed separately. The management requirements of protective gowns are basically similar to those of masks. | |
| New requirement | New medical regulation (EU) 2017/745 (MDR) will enter into force on May 26, 2020. | |
| US | Application of FDA Logo | According to the FDA Logo Policy, even if a registration application for a medical device is approved by the FDA, the FDA logo shall not appear on the package or label. |
| FDA certificate | FDA has clarified in its Device Registration and Listing that FDA will neither issue certificates of registration to medical device organizations, nor certify the registration and listing information of registered and listed companies. | |
| Requirements applied for epidemic prevention products | Masks are divided into surgical masks and personal protective masks, which are managed separately. The management requirements of protective gowns are basically similar to those of masks. | |
| Emergency Use Authorization (EUA) | There are currently two types of organizations that can apply for EUA: laboratories and medical-device companies. However, EUA authorization is a temporary pathway and its expiry dates are subject to the latest FDA notice. |
Link: http://english.mofcom.gov.cn/article/newsrelease/significantnews/202004/20200402959471.shtml
https://www.cmde.org.cn/CL0033/20821.html
