Vietnam Medical Device Regulations

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Vietnam issues new regulation for medical device management

https://andamanmed.com/vietnam-issues-new-regulation-for-medical-device-management/

Regulatory updates, Vietnam. On 8 November 2021, the Vietnam government signed Decree 98/2021/ND-CP regulating the management of Medical Devices. The new decree enters into force on 01 January 2022. From this date, Decree 36/2016/NĐ-CP, …

Vietnam Medical Device Registration - International …

https://www.trade.gov/market-intelligence/vietnam-medical-device-registration

In 2019, the Vietnam Medical Device (MD) market was valued at $1.4 billion, making Vietnam the ninth largest market in the Asia-Pacific region. Over 90% of medical …

Vietnam Releases New Medical Device Regulations

https://asiaactual.com/blog/vietnam-releases-new-medical-devices-regulations/

At this time, software is considered a medical device and will require registration in Vietnam. As Article 3, point 8 of 98/2021 states: 8. The provisions of this …

Medical Device Registration in Vietnam - Asia Actual

https://asiaactual.com/vietnam/medical-device-registration/

Registration requirements for medical devices in Vietnam are currently in a state of transition. New rules governing the registration of …

Vietnam: New Decree on management of medical devices

https://www.globalcompliancenews.com/2022/01/19/vietnam-new-decree-on-management-of-medical-devices-07012022/

4. Price management. Decree 98 sets out new regulations on price management measures for medical devices in order to address shortcomings and …

Medical Device and IVD Registration and Approval in …

https://www.emergobyul.com/services/medical-device-and-ivd-registration-and-approval-vietnam

Vietnam Medical Device Regulations. Medical devices and in vitro diagnostic devices (IVDs) are regulated by the Department of Medical Equipment and Construction (DMEC) under the Ministry of Health in …

Vietnam Medical Device Registration - DMEHW …

https://arazygroup.com/medical-device-registration-vietnam/

Official Device Classification – 10 working days. Import License (registration for devices under Circular 30): 1 – 3 months. Product registration (regular pathway): 10-12 …

Medical Device registration in Vietnam - CMS MedTech

https://cmsmedtech.com/medical-device-registration-in-vietnam/

There are currently 2 main regulations (call “Circular”) in place for medical device registration in Vietnam. New Regulation is call Circular 36. It should be read in conjunction with Decree 169/2018 (which …

Vietnam Amends Medical Device Regulations - 2019

https://www.regdesk.co/vietnam-amends-medical-device-regulations-2019/

Jan 7, 2020. The Government of Vietnam, at the proposal of the Minister of Healthcare, has published a decree amending and supplementing national medical device regulations. The proposed …