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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 commercial 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

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SOUTHEAST ASIA

HEADQUARTERS

116 Changi Road, #04-05
Singapore 419718

+65 8800-3197

Latest News.

China’s NMPA Updates Medical Device Classification Catalogue

China’s National Medical Products Administration (NMPA) maintains a list of all medical device categories called the Medical Device Classification Catalogue. NMPA published a notice on August 17, 2023, that they had released amendments to the Medical Device Classification Catalogue. It’s important for manufacturers to understand these changes as they can significantly impact the cost and time to register medical devices.
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Thai FDA Drafting New Guidance for SaMD and AI Device Registration

Thai FDA is drafting new guidelines for AI Regulation. The novel characteristics of artificial intelligence (AI) software cause issues with the medical device registration process in most countries. The Thai Food and Drug Administration (Thai FDA) is working to address this important issue, most recently by hosting a meeting with interested parties on July, 2023, which Asia Actual Thailand employees were invited to attend.
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China NMPA Adds 47 Products to Clinical Trial Exemption List

China’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. This brings the total number of clinical trial exempted product categories in China to 1,025.
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