Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices.
The Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) on 20 September, 2022 that, if formalized, would exempt Class A non-measuring and non-sterile medical devices.
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.
Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
Korea’s Ministry of Food and Drug Safety (MFDS) recently published final revisions regarding importing non-registered medical devices under special circumstances, including for research and personal use only, scarce or urgently needed, to be used by a Korean laboratory, clinical trials and/or orphan products.
Singapore’s HSA has updated their requirements for software application submissions, requiring the specific version number and iteration of the software to be sold in Singapore.
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 Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D.
Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
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.
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