The Asia region continues to be a significant growth engine for our clients.
Asia Actual was specifically designed and constructed to support medical device manufacturers to quickly gain and maintain access to dynamic and lucrative Asian markets.
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March 15, 2024
Reminder that China NMPA's UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled. ...
Read MoreMarch 13, 2024
On February 21st, 2024 the TFDA provided data to show a reduction in application review times and increased accessibility with their digital service system. ...
Read MoreFebruary 29, 2024
Per Decree 07/2022, the application requirements for new Class C and D applications submitted to the Vietnamese Ministry of Health (MoH) after January 1, 2024 will need to be in ASEAN Common Submission Dossier Template (CSDT) format, with the addition of a Vietnamese IFU....
Read MoreFebruary 27, 2024
On January 1, 2024, India's CDSCO released a notice announcing the roll-out of the NSWS....
Read MoreFebruary 20, 2024
On April 1, 2024, the Central Drugs Standard Control Organization's (CDSCO) grace period for Non-Regulatory Class C and D medical devices in India comes to a close....
Read MoreFebruary 14, 2024
Last month, the Thai FDA announced new quality systems requirements that apply to the manufacture and distribution of medical devices, and for conducting clinical trials in Thailand....
Read MoreJanuary 29, 2024
Starting January 1st, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the National Medical Products Administration (NMPA) of Mainland China and the Ministry of Food and Drug Safety (MFDS) of Korea as support of ...
Read MoreJanuary 25, 2024
The Thai FDA hosted a seminar for public discussion and training of the full CDST application, which was attended by Asia Actual Thailand personnel. At the event, the Thai FDA announced its intention to decrease the application pre-screening time from 30 days to 1 working day....
Read MoreJanuary 22, 2024
In a training seminar held on January 15 and 16, 2024, by the Thai FDA on the Full Common Submission Dossier Template (CSDT), the TFDA stated their intention to improve the advertising approval process. Per the Deputy Secretary General, they plan to implement new processes meant ...
Read MoreJanuary 22, 2024
On January 3, 2024, Hong Kong’s Medical Device Division (MDD) issues the Technical Reference document TR-008: Artificial Intelligence Medical Devices (AI-MD). It provides clarity for devices using AI (AI-MD) and machine learning, including Continuous Learning Capability (CLC) a...
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