GROWING MEDICAL DEVICE SALES

WITH OUTSTANDING COMPLIANCE & COMMERCIAL EXPERTISE

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.

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COMMERCIAL SERVICES

Solving sales channel issues with experienced local experts

  Distributor Matching  |  New Tech Launch Support  | Sales Performance Reports |  Sales Channel Management

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)

BINH THAI

GENERAL MANAGER
(THAILAND)

GUNJAN VERMA

MANAGING PARTNER
(INDIA)

CHARMAINE ROSON

PRINCIPAL CONSULTANT
(PHILIPPINES)

Glend Llantada

IMPORTATION SPECIALIST
(SOUTHEAST ASIA)

SARAH BAIK

PRINCIPAL CONSULTANT
(KOREA)

ERIC LEUNG

GENERAL MANAGER
(HONG KONG)

ILHAM HIDAYATTULAH

PRINCIPAL CONSULTANT
(INDONESIA)

KENNA RASIKLAL

PRINCIPAL CONSULTANT
(SINGAPORE)
Russia Medical Device Consultant

TATIANA NOSOVA

PRINCIPAL CONSULTANT
(RUSSIA)

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

500 registered products

to date

Recent News from Asia

medical device registration

India Seeks Input on Medical Device Classification

All formerly unregulated medical devices are now being transitioned to require registration in India under the Medical Device Rules, 2017.  These products should be Registered prior to October 1, 2021 and then obtain an Import License before October 1, 2022, or October 1, 2023 depending on the product’s risk classification.
IVD equipment classification

India Seeks Input on IVD Equipment Classification

All IVD related equipment, instruments and software is now being transitioned to require registration in India under the Medical Device Rules, 2017, joining IVD reagents and kits which have been regulated since January 1, 2018, if not before.
Clinical Trial Exemption

CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LIST

As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.