Regulatory Open Forum

According to the new medical device regulation in Vietnam, effective Jan 2018, companies shall gain registration approval in order to continue selling or begin selling medical devices.

To register the product in Vietnam does the foreign company have to register their legal entity or establish a local authorization holder in Vietnam before they can legally submit the product registration application? If yes, how long will this step take?

Thanks in advance!

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Andrea Curria
Regulatory Affairs Specialist
Cumberland RI
United States
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If you have a legal entity then it is fine. If not, you need to have a 3rd party to hold your product license. Your local Vietnamese distributor can also hold your product license.
Estimated processing time is 4-6 months.

Regards
Sreenu
Original Message:
Sent: 24-Jul-2017 09:12
From: Andrea Curria
Subject: Question Regarding New Vietnam Regulations

According to the new medical device regulation in Vietnam, effective Jan 2018, companies shall gain registration approval in order to continue selling or begin selling medical devices.

To register the product in Vietnam does the foreign company have to register their legal entity or establish a local authorization holder in Vietnam before they can legally submit the product registration application? If yes, how long will this step take?

Thanks in advance!

------------------------------
Andrea Curria
Regulatory Affairs Specialist
Cumberland RI
United States
------------------------------