In 2018 the NMPA launched an accelerated pathway for the examination and approval of innovative medical devices also known as Green Channel.
Green Channel Requirements:
To qualify for NMPA fast-track review and approval pathway the medical devices and/or IVDs should :
1. Be Class II or Class III Medical Devices or IVDs with significant clinical application value,
2. Own valid invention patents,
3. Have China PTO coverage,
4. Complete the preliminary study on prototype with traceable data, and
5. Have an authorized in-country legal entity.
Download our Whitepaper for a summary on how China’s Green Channel Pathway for innovative Medical Devices and IVD’s.
About Global Regulatory Partners Inc:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.