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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

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Southeast Asia Headquarters

116 Changi Road, #04-05
Singapore 419718

+65 8800-3197

Latest News.

Australia SaMD Transition Deadline

Australia’s SaMD Regulatory Deadline

Beginning on November 1st, 2024, Australia's Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.
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Thai FDA Documentation Exemptions for Concise and Full Regulatory Pathways

Thai FDA Regulatory Documentation Exemptions

March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.
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Hong Kong MDD adds Singapore HSA to Reference Country List

Hong Kong MDD Adds Singapore as Reference Country

Starting April 2nd, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under MDACS.
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