New Work Program for the Medical Device Surveillance and Development in GBA
NMPA released a notice regarding a New Work Program for the Medical Device Surveillance and Development in GBA (Guangdong-Hong Kong-Macao Greater Bay Area) [No. 159 0f 2020] on November 25, 2020. With this Work Program, qualified medical institutions in GBA may, according to relevant regulations, use drugs and medical devices that have been approved and marketed in Hong Kong and Macao.
With an approval of the Government of Guangdong Province, medical devices, with advanced clinical application and urgent clinical need, which have been purchased and used by public hospitals in Hong Kong and Macao, can be applied to qualified medical institutions in the mainland of GBA.
Key Takeaways for the Work Program
- Regulatory Changes. Cities and areas within GBA will suspend the implementation of the Article 11 (2) of Regulation on the Supervision and Administration of Medical Devices. Please email us for the detail and explanation of this Article.
- Implementation location. The Work Program will be implemented in designated medical institutions and Shenzhen Hospital of University of Hong Kong will be the first trial spot now.
- Device catalogue. Medical devices, with advanced clinical application and urgent clinical need, which have been purchased and used by public hospitals in Hong Kong and Macao, will be listed in the imported medical device catalogue according to actual clinical needs by the relevant authorities of Guangdong Provincial, Hongkong and Macao. This catalogue will be adjusted dynamically.
All the innovative measures in the Work Program will grant the People’s government of Guangdong province the inspection and approval authority, and will gradually provide people in GBA with equivalent medical device conditions. Please email us info@inspirativemed.com for more information about this new policy.
Link: https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20201020145834142.html
