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.
Come grow with us!
January 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...
Read MoreJanuary 17, 2024
Hong Kong’s Medical Device Division has released a new technical reference document related to software medical devices (SaMD and SiMD). Released on December 29, 2023, TR-007: Software Medical Devices and Cybersecurity, aims to provide more clarity for Software in a Medical Dev...
Read MoreDecember 15, 2023
On November 29th and 30th the Philippines FDA hosted a public forum to review and field questions on plans to change the fee schedule for processing registration applications as outlined in a recent draft Administrative Order (available here) and it's corresponding Annexes....
Read MoreDecember 7, 2023
On November 30th, the Hong Kong Medical Device Division (MDD) issued formal guidance on the requirements to make changes to medical device licenses registered in the Medical Device Administrative Control System (MDACS)....
Read MoreNovember 29, 2023
The Central Drugs Standard Control Organisation (CDSCO) of India issued a notice (PDF) on October 25, 2023 classifying in-vitro diagnostic (IVD) medical devices under medical device rules. The updates to IVD classification in India include intended use, associated risk, and other...
Read MoreNovember 2, 2023
On October 6, 2023, a team of enthusiastic members from the AAI (Artificial Intelligence and Innovation) group, including Ashoniya Puri, Sanjay Singh, and Rajat Budhori, had the honor of attending the prestigious 15th CII Global MedTech Summit. Hosted by the Confederation of Indi...
Read MoreOctober 17, 2023
On September 18, 2023, The Directorate General of Drug Administration (DGDA) published the Drug and Cosmetics Act 2023 formalizing the regulatory requirements of medical and diagnostic devices in Bangladesh with immediate effect. A translated version of the document is availabl...
Read More