The widely reported shortages of Personal Protective Equipment (PPE), including masks and gowns, across the United States have led to the importation, distribution and use of PPE manufactured overseas. In particular, many U.S. distributors and end users are looking to import products from China.
This could be an effective solution for many stakeholders provided the arrangement complies with both U.S. and Chinese regulatory requirements. Both countries continue to update their relevant regulatory policies, with a number of changes announced since April 1, 2020.
The application of these regulations is product specific. Companies looking to import any PPE must perform the appropriate diligence on the regulatory treatment of the specific product that they intend to import.
In the U.S., PPE is generally regulated by the U.S. Food and Drug Administration (FDA) as medical devices. Therefore, manufacturers must comply with medical device regulations, which include the FDA's rules on importation of devices.
Specifically, to lawfully import PPE, foreign manufacturers and initial importers must comply with two primary requirements:
In response to the COVID-19 pandemic and the recognized shortage of PPE, FDA has recently developed new enforcement policies to try to expedite the importation of these products.
Very recently, China imposed more restrict control on exporting PPEs combating COVID-19. Last week, China's Ministry of Commerce (MOFCOM), General Administration of Customs (GAC) and National Medical Products Administration (NMPA) released a new regulation to regulate the export of medical supplies from China amid the COVID-19 crisis. Starting April 1,2020, when entities that export coronavirus detection reagents, medical masks, medical protective clothing, ventilators and infrared thermometers declare their products to U.S. Customs and Border Patrol, they must provide a written or electronic document stating that the products have obtained China's Medical Equipment Product Registration Certificate and at the same time meet U.S. regulatory and quality standards.
The new regulation was triggered by the complaints from governments of three European countries through high-level diplomatic channels. No products without NMPA approval can be exported from China. The Chinese customs and ports authorities have been vigorously enforcing this regulation and carefully inspecting all products to prevent non-compliant products from leaving the borders of China.
Holland & Knight's attorneys have extensive experience in both FDA's and China's medical device laws and regulations. The situation is fluid and changing daily. For questions about a situation specific to your healthcare organization, please contact the authors.
DISCLAIMER: Please note that the situation surrounding COVID-19 is evolving and that the subject matter discussed in these publications may change on a daily basis. Please contact your responsible Holland & Knight lawyer or the author of this alert for timely advice.
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