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.

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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 Dynamic companies from 20 Countries
with over

1,000 registered products

to date

Recent News from Asia

India Grants Import License Grace Period for Class A/B Devices

Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices.
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Class A Exempt Instruments

India Issues Draft Notification for Exempting Certain Class A Medical Devices

The Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) on 20 September, 2022 that, if formalized, would exempt Class A non-measuring and non-sterile medical devices.
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Transfer of Product Registration of Alcohol Swabs from CDRRHR to CDRR

Announced on September 6, 2022, FDA Advisory 2022-1576, the Philippines FDA has announced that the alcohol swabs with at least 70% isopropyl alcohol intended for antiseptic use now falls under the jurisdiction of the Center for Drug Regulation Research (CDRR) under Household Remedy Products.
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