08/05/2020
With the impact of COVID-19, the export of medical devices becomes a major concern for European stakeholders. On April 11, General Administration of Customs issued the Announcement No. 53, stipulating to conduct export inspection on 11 medical products including medical mask, medical protection suit, Infrared thermometers, breathing machine, medical operating cap, goggle, glove, and shoe cover, patient monitoring apparatus, medical disinfection towel, and medical disinfector. On April 17, 2020, SAC published 14 new mandatory national standards to standardize disinfectants and devices for epidemic control, covering requirements for hand sanitizers, air sanitizers, floor sanitizers, ultra-violet sanitizing machines, ozone sanitizing machines, medical electronics, intensive care ventilators, and ultra-sound diagnosis and monitoring products. Together with the NMPA (National Medical Products Administration) registration rules, all these have caused much confusion for European stakeholders. Hence, SESEC did the following researches trying to sort out the relations between these policies and their impacts on relevant products.
- GB standards and NMPA registration
GBs apply to all products produced in China, except for those to be directly exported. In that case, the standards in importing countries prevail. NMPA registration rules apply to all Class II and Class III medical devices.
Take as an example GB 2626-2019 (Respiratory protection – Non-powered air-purifying particle respirators), this standard is for masks for industrial purposes, which are not under the management scope of NMPA. So, the products covered by GB2626 have nothing to do with NMPA registration procedures. Masks for medical purposes must follow GB 19083 and go through the NMPA registration processes before export.
- Disinfection products and NMPA registration
In principle, disinfection products, including disinfecting apparatus, are managed by the National Health Commission. These product must be registered in local health administrative departments before being put on the market (Notice of National Health and Family Planning Commission on the Issuance of Hygiene and Safety Evaluation Provisions for Disinfection Products). However, some disinfection products and disinfecting apparatuses, such as citric acid disinfectant for dialyzers, steam sterilizers, ethylene oxide sterilizers, etc., are also classified as medical devices. In that case, these products must follow the NMPA rules (Announcement of the NMPA on the Publication of the Classification Catalogue of Medical Devices).
- PPE/medical device products export
In general, Class II and Class III medical devices must follow the NMPA registration rules whether they are covered by the newly released GBs or the new Announcement No. 53 issued by General Administration of Customs.
| No. | Products | Covered by New GBs | Covered by NMPA Registration | Covered by Announcement No. 53 of China Customs |
| 1 | Hand sanitizers | Y | N | N |
| 2 | Air sanitizers | Y | N | N |
| 3 | Floor sanitizers | Y | N | N |
| 4 | Ultra-violet sanitizing machines | Y | Y | N |
| 5 | Ozone sanitizing machines | Y | Y | N |
| 6 | Medical electronics | N | Medical electron accelerators | Infrared thermometers, breathing machines, and patient monitoring apparatus |
| 7 | Intensive care ventilators | Y | Y | Y |
| 8 | Ultra-sound diagnosis and monitoring products | Y | Y | N |
The table above indicates that intensive care ventilators are hard to be exported to the EU; sanitizing machines take the second place, but they will not be affected by the new rules; export of sanitizers will not be affected by these rules