Medical Device Regulations In Vietnam

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Vietnam issues new regulation for medical device management

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

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, Decree 169/2018/NĐ-CP, and …

Vietnam Medical Device Registration - International …

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

Medical Device Management Regulations: On May 15, 2016, the Government of Vietnam issued Decree 36/2016/ND-CP, regulating the management of medical equipment …

Vietnam Releases New Medical Device Regulations

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

Nov 16, 2021

Medical Device Registration in Vietnam

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

Government Authority. Medical Device product registration in Vietnam is overseen by the Department of Medical …

Vietnam: New Decree on management of medical devices

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

Decree 98 also sets out regulations on: (i) handling of medical devices that pose a serious threat to public health or may lead to users’ death; (ii) actions to be …

New Rules for Vietnam’s Medical Devices …

https://www.vietnam-briefing.com/news/vietnams-medical-devices-industry-new-law.html/

New Law Impacts Foreign Players in Vietnam’s Medical Devices Industry × Menu Economy & Trade Industries Tax & Accounting Legal & Regulatory HR & Payroll Events Publications …

Vietnam Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/vietnam/

Vietnam Medical Device Regulations Agency All medical devices are regulated by Department of Medical Equipment and Health Works (DMEHW) under the Ministry of …

Medical Device and IVD Registration and Approval …

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

As of January 1, 2022, regulated medical devices and IVDs can only be marketed in Vietnam if they have a Marketing Authorization Code (MAC). The pathway to obtain a MAC is based on the classification …

Vietnam Amends Medical Device …

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

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 …

Medical Device registration in Vietnam

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

Updated: 20th July 2020 Medical Device Registration in Vietnam There are currently 2 main regulations (call “Circular”) in place for medical device registration in Vietnam. New Regulation …

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