Growing Medical Device Sales in Asia

With Outstanding Regulatory Compliance and Commercial Expertise

Asia Actual is a leading medical device regulatory consulting company providing customized market access solutions through registration, independent license holding, and importing support services to all medical device manufacturers, including software, novel, and high-risk devices.

We distinguish ourselves with (1) outstanding personnel; (2) clear communication; and  (3) transparent operations. We have offices staffed by experienced, bilingual regulatory and commercial professionals in the major capital cities of Asia.

Our mission is to provide a stable, reliable local platform so that our clients can grow their sales in challenging Asian markets.

Let Us Help You Grow Your Sales.

Speak to a Local Regulatory Professional Today

At Asia Actual, we aren’t just your ordinary regulatory partner; we empower manufacturers with a comprehensive understanding of the regulatory landscape while leveraging our extensive commercial knowledge. Our expertise extends beyond compliance, enabling us to collaboratively craft regional market access strategies that align with your business goals. With a holistic approach, we not only ensure adherence to regulations but also strategically position your products for success in diverse markets, fostering a seamless and strategic path to market entry and sustained growth in one of the fastest growing regions.

Meet our Experts

Asia Actual takes pride in its medical device regulatory experts who stand as industry leaders, boasting an impressive average of 15 years of invaluable experience in their respective markets. With a commitment to transparencey, excellence, and clear communication; our seasoned professionals will help you navigate the complex regulatory landscapes to help you gain quick market access and maintain compliance throughout Asia.

BRYAN GILBURG

MANAGING DIRECTOR
(USA)

GUNJAN VERMA

MANAGING PARTNER
(INDIA)

ILHAM HIDAYATTULAH

PRINCIPAL CONSULTANT
(INDONESIA)

CHARMAINE ROSON

PRINCIPAL CONSULTANT
(PHILIPPINES)

Glend Llantada

IMPORTATION SPECIALIST
(SOUTHEAST ASIA)

SAYOOMPORN (NOI) SUWANNABOT

GENERAL MANAGER
(THAILAND)

ERIC LEUNG

GENERAL MANAGER
(HONG KONG AND TAIWAN)

SARAH BAIK

PRINCIPAL CONSULTANT
(KOREA)

DAVID VO

GENERAL MANAGER
(VIETNAM)

KENNA RASIKLAL

PRINCIPAL CONSULTANT
(SINGAPORE)

ALBERT PRANOTO

HEAD OF BUSINESS DEVELOPMENT - ASIA (SINGAPORE)

The future is bright.

Asia Actual’s innovative approach of leveraging regulatory compliance to create novel sales channel management tools has made us the fastest growing consultancy in the region. The formula is a winning one. Come grow with us.

We represent over 100 Dynamic companies from 20 Countries
with over

1,000 registered products

to date

Search Our Medical Device Regulatory Knowledge

Recent Medical Device Regulatory News from Asia

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.
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.
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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