05 Years

of experience

 

 

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About us

MEDGATE is a trusted regulatory partner supporting domestic and international clients in bringing products to the market.

With a team of experienced pharmacists and regulatory experts, MEDGATE provides end-to-end regulatory consulting and product registration services for medical devices and pharmaceuticals, including medical device registration, health supplement declaration, cosmetic notification, self-declaration of supplemented food, pharmaceutical registration, Local Authorized Representative services, import procedures, and post-market compliance management. Our solutions ensure regulatory compliance, risk mitigation, and efficient market access in Vietnam.

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OUR SERVICES

Our mission is to constantly strive to become a reliable and trusted legal partner to accompany customers, to improve patients’ lives through medicines, health protection foods, and medical equipment. Medical equipment is being provided.

YOUR INFOMATION AND QUESTION

Please leave complete and accurate information, Medgate will contact you immediately within 24 hours for free consultation and answer your questions.






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    OUR PARTNERS

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    REGULATORY UPDATES

    The implementation of Decree No. 46 is suspended pending the enactment of the amended Law on Food Safety.

    📢 New Update: Suspension of Decree No. 46/2026/NĐ-CP 👉 The Government has issued Resolution No....

    MINISTRY OF HEALTH ISSUES NEW GMP CERTIFICATION PROCEDURE FOR HEALTH SUPPLEMENTS

    📌 On March 30, 2026, the Ministry of Health issued Decision No. 808/QĐ-BYT on the...

    📌 Official Letter No. 1965/BYT-HTTB – Report on the Implementation of Decree 98/2021/ND-CP

    The Ministry of Health has issued an official request for organizations and companies in the...

    Update on Cosmetic Ingredient Regulations under the ASEAN Cosmetic Directive (2026)

    On 25 February 2026, the Drug Administration of Vietnam (DAV) – Ministry of Health issued...

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    REGULATORY KNOWLEDGE