Bryan Gilburg - China

“The establishment of an advisory council will help new medical device regulations transition smoothly in Vietnam.”

Bryan Gilburg, Asia Actual

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

Vietnamese MOH Establishes New Medical Device Advisory Council

Published on: November 20, 2020

Prof. Dr. Nguyen Thanh Long, Minister of Health, awarded the Decision to establish an Advisory Council to license the circulation of medical equipment. Prof. Dr. Le Quang Cuong, former Deputy Minister of Health, will become the President and Chairman of the Association.

Council is to Advise on New License Issuance and Renewals

On November 18, 2020, the Vietnamese Ministry of Health (MOH) released Decision No. 4353 / QD-BYT officially establishing an Advisory Council to oversee the efficient and transparent implementation of new medical device rules. The council will be led by Dr. Le Quant Cuong, the former Deputy Minister of Health, and is tasked with overseeing new registrations of higher risk devices and the extension of existing medical equipment registrations. The council will have 17 members and is scheduled to begin work in May 2021.

The formation of the Council is seen as an important step to a smooth implementation of the new medical device regulations in Vietnam which are scheduled to come into effect on January 1, 2022.  Depending on the Council’s progress, there is potential that the MOH could release new guidance in Q2 of 2021 and begin issuing Class B, C, and D product licenses as early as Q3 or Q4 of 2021.

Current Requirements in Vietnam

Currently, the Vietnamese regulations are in transition from Circular 30 to Decree 36 with a full transition completed in 2022. Currently, only Class A products and specific Class B, C, and D, as designated in Circular 30, are required to have a Market Authorization license (MAH) to clear customs. Products not found on the Circular listing may now clear Customs and sold in Vietnam without an Import License until December 31, 2021. However, medical devices should have their products classification confirmed by a local, qualified classification agent to ensure expeditious customs clearance. From January 1, 2022, these devices will also require a Market Authorization License (under the new Rules).  Medical devices manufacturers should work with their local agents to determine the specific regulatory requirements for their portfolio now and after January 1, 2022.

Grow With Us

Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with questions or support requests.

Blog Posts

Singapore HSA Regulations on Hand Sanitizers, Masks, Thermometers, and Protective Gear

Hand sanitizers are not considered medical devices and therefore, do NOT need approval from the Health Sciences Authority (HSA) in Singapore.

Vietnam to Require Annual Inspection of Certain Medical Equipment

On December 31st, 2020, the Ministry of Health (MoH) issued Circular No. 30/2020 providing a list of medical equipment subject to annual safety inspections and technical capability assessments, along with the timelines for implementation.

India’s CDSCO Extends List of Notified Devices

On December 28th, 2020, the Central Drugs Standard Control Organization announced that Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers must obtain Import Licenses prior to marketing.