In recent weeks, the Chinese government has faced criticism from governments around the world about the quality of medical equipment manufactured in China.
In response, the Chinese government has adopted measures to heighten the standard of exported medical equipment. Effective April 1, 2020, the Chinese government is requiring medical equipment exporters to declare that the products meet the standards of the importing country as well as proof of registration certifications from the China National Medical Products Administration and relevant provincial-level Chinese authorities. The Chinese government also provided, in the Chinese language, a declaration template for medical equipment exporters and a list of companies that have already registered their medical equipment with the Chinese government or provinces.
Following the April 1 development, the Chinese government announced on April 10 that China’s Customs Administration would conduct inspections of medical equipment, including face masks, disinfectants, disinfecting towels, protective gowns, ventilators, surgical caps, shoe covers, patient monitors, protective goggles and medical gloves before export from China.
Faegre Drinker partnered with the American Chamber of Commerce in Shanghai to establish “best practices” for purchasing quality medical equipment in China and to provide other documents to facilitate legal due diligence by Chinese suppliers at this critical time. In addition, with knowledge in the area of medical devices and in vitro diagnostics, Faegre Drinker professionals help ensure that these critical products meet appropriate FDA standards and other legal requirements.
As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.