Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.
In an ongoing effort to refine and improve the systems and procedures for medical device registration in China, the National Medical Products Administration or NMPA (previously the CFDA) moved to a new on-line submission system and harmonized the applications table of contents to international standards.
China has been making efforts to encourage more direct investment. Along with the new Foreign Investment Law, the NMPA has also announced incentives for manufacturers opening facilities in China by making the application process easier and faster.
Chinese officials are taking steps to reduce fraudulent exports. Only products with NMPA registration can be exported to ensure standards and quality during COVID-19 crisis.
The changes to clinical data requirements will significantly decrease the regulatory burden for many medical device manufacturers seeking to access the Chinese market by eliminating the time and expense of conducting a local clinical trial.
COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.
The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you’re considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs. Asia Actual Can Help Navigate the Evolving Regulatory Process in China
As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.