GROWING MEDICAL DEVICE SALES

WITH OUTSTANDING COMPLIANCE & COMMERCIAL EXPERTISE

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Registered Device Licenses in Asian Markets

Asia Actual provides registration, independent license holding, and importing support services to medical device manufacturers including 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.

REGULATORY COMPLIANCE

Leading, local regulatory specialists dedicated to your medical device registrations, maintenance and renewals

    Clinical Trial Data  |  Reimbursement  |  In-country Representation

Meet our Experts

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)
Russia Medical Device Consultant

TATIANA NOSOVA

PRINCIPAL CONSULTANT
(RUSSIA)

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 Dynmaic companies from 20 Countries
with over

1,000 registered products

to date

Recent News from Asia

Vietnam Requires Resubmission of Many Medical Device Registration Applications

All unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.

China to Accept Foreign Generated Test Reports

This adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.

India Postpones Registration Requirements for Certain Medical Devices

With the release of a new order on Nov 3, 2021, CDSCO has postponed the Import Licensing requirement for 8 categories of medical devices.

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