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Expert Medical Device Consulting and Market Access Solutions

Headquartered in Austin, Texas, Asia Actual has offices staffed by experienced, bilingual regulatory and market access professionals in the major capital cities of Asia.

We distinguish ourselves with (1) outstanding personnel; (2) clear communication; and  (3) transparent operations.

Please contact us today for a free consultation to learn more about your market access options in Asia.

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US Headquarters

515 Congress Avenue, Suite 2100
Austin, TX 78701

+1 512 898-9222

inquiry@asiaactual.com

Southeast Asia Headquarters

116 Changi Road, #04-05
Singapore 419718

+65 8800-3197

Latest News.

Woman Scanning China UDI Medical Device after June 1st, 2024 Implementation

China’s Third Batch of UDI Implementation Deadline in June

Reminder that China NMPA's UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.
Most efficient TFDA application processing review time

Thai FDA Reduces Application Review Time

On February 21st, 2024 the TFDA provided data to show a reduction in application review times and increased accessibility with their digital service system.
Map showing Vietnam where updates to CSDT are taking place.

Vietnam’s MoH Updates Class C and D Application Requirements

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.