China: NMPA allowed Hong Kong/Macau approved medical device in Guangdong China
The National Medical Products Administration (NMPA) has announced in Article 11, item 2, Decree 68 that it will pilot a program to allow public hospitals in major Guangdong cities to import medical devices that have been approved in Hong Kong and Macau. The initiative has been titled – “Work Plan for Supervision, Innovation and Development of Drugs and Medical Devices in Guangdong-Hong Kong- Macau Greater Bay Area” and will extend to 8 major Guangdong cities.
On 29th September 2020, NMPA along with 7 other authorities has jointly came up with the Work Plan for Innovative Development of the Regulation of Drugs and Medical Devices in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA). The work plan is carried out to support the outline development plan for the GBA and establishes many innovative measures. The work plan also implements the Four Most Stringent Requirements entirely to increase the safety and quality assurance for drugs and medical devices.
On 29th December 2020, China’s NMPA signs memorandum of understanding (MoU) on regulatory cooperation of medicines, medical devices, cosmetics with Italian Ministry of Health, Italian Medicines Agency. Although the drug regulatory departments of China and Italy have always maintained a good cooperative relationship, the framework of the MoU can help strengthen that and can lead to many mutual benefits. Such benefits include the enhancement of regulatory capabilities and further deepening the regulatory cooperation of medicines, medical devices and cosmetics.
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