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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.

Japan's Innovative Medical Device Regulatory Pathway is called Sakigake

Innovative Medical Device Registration in Japan

In 2019, Japan's Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) introduced a innovative device registration designation system, called Sakigake, which is meant to streamline the regulatory pathway for qualifying medical products.
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PMDA Representative consulting with medical device manufacturers in Japan

Medical Device Consultation in Japan

Medical device consultation in Japan is a very involved but essential process in registering a medical device. A significant part of the regulatory process in Japan is consultation meetings with the Pharmaceuticals and Medical Devices Agency (PMDA).
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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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