Your premier option for market access solutions across Asia.
Asia Actual is the leading medical and diagnostic device consulting company providing expedited registration options, independent license holding, importing, and commercial support services in Asia.
To provide a stable, reliable local platform so that our clients can grow their businesses in challenging Asian markets. We strive to provide the fastest market access and customs clearance for important medical device innovations.
Asia Actual regulatory and business managers average at 21 years of experience in the medical device industry
“Our experience working with Asia Actual is that the team is composed of highly competent, communicative, and knowledgeable staff. This has improved our time to market across many geographies and allowed us to take control of our device registrations.”
Charles DeNault
Associate Director Regulatory Affairs,
Penumbra
Clear communication
Our offices are staffed by experienced, bilingual consultants who have worked with and for multinational companies
“We changed regulatory consultants in India due to constant communication problems, and now Gunjan and her team saved our project.”
Shay Levav
Vice President Quality Assurance, Regulatory Affairs and Clinical,
IceCure Medical Ltd.
Transparent operations
Our importing protocols include per-shipment expense reporting
“We were looking to find a regulatory partner in the Asian markets which fit our business operations more efficiently than those we had been working with in the past or evaluating previously. In our search we talked with then implemented a few trial registration projects with Asia Actual; their direct contacts in country, clarity and continuous contact approach fit much better with our needs to get first-hand information without having to go multiple tiers of relationships. This approach allows us to get applications in the hands of the regulators more quickly and product to market on time. We are continuing to expand our engagement with Asia Actual to more countries in Asia to get our products to market on time.”
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 quickly gain and maintain access to dynamic and lucrative Asian markets.
“The team at Asia Actual has seamlessly guided us through the intricate process of compliance to the Indian Medical Device Regulation and helped unravel a challenging situation based on prior inaccurate guidance. From initial assessments to the submission of regulatory documentation, every step was executed with precision and efficiency. Their attention to detail and proactive approach paved the way for successful market access and getting our project on the right track. Their expertise not only saved valuable time and resources but also positioned us for long-term success in an increasingly competitive industry.”
Tina O’Brien
Director of Global Regulatory Affairs and Strategy, Aroa Biosurgery Limited
“We received strong supports from beginning of Cordis in Philippines. I don’t need to worry about any regulatory and quality operations managed by local experts – Charmaine and Karla.”
Inho Dan
Senior Quality and Regulatory Manager, Cordis
“Navigating and understanding the specifics of local country medical device submissions is a complicated undertaking. The local in-country teams at Asia Actual really did a fantastic job at making our submissions painless. They knew exactly the content needed by the local authorities. Where there was misalignment between the content we submitted and what was required, the Asia Actual teams got back to us quickly with the information needed to make our submission conform to the local requirements. In one instance, we needed to complete a registration with an aggressive timeline. The Asia Actual team worked with the local authorities to push our submission, and we completed the device registration on time.”
Brian Brown
Senior Vice President of Engineering, Quality, Regulatory, and Compliance, Belluscura
Recent Medical Device Regulatory News in Asia
November 4, 2024
How to Transfer a Medical Device License in Thailand
Thai FDA license transfer guidelines, updated September 19, 2024: Key documents and steps for compliant medical device transfers in Thailand....
Vietnam Allows Amendments to Registration Applications Under Review
On August 16th, 2024, Vietnam MoH introduced new guidance allowing amendments to registration applications under review, enabling document updates during the process....
