1. Medical devices regulations in Vietnam
- Decree No. 07/2023/NĐ-CP, amendments to government’s decree No. 98/2021/NĐ-CP dated November 08th, 2021 on management of medical devices. This Decree takes effect from March 03rd, 2023.
- Decree No. 98/2021/ND-CP on management of medical devices. This Decree takes effect from January 1st, 2022.
- Circular No. 05/2022/TT-BYT detailing the implementation of a number of articles of Decree 98/2021/ND-CP on medical device management.This Circular takes effect from August 1st, 2022.
- Circular No. 30/2015/TT-BYT import of medical equipment. This Circular takes effect from 2015 and expires on December 31st, 2022.
2. Medical Devices Registration in Vietnam
The registration process for medical devices is governed by the Ministry of Health and Department of Health. Take a look at the flow-chart and step-by-step guide on the registration process below:
For manufacturers that has no representative office in Vietnam, we highly recommend appointing a commercial representative in Vietnam that is authorized as Marketing Authorisation Holder.
3. Why choose Airseaglobal Group as your Marketing Authorisation Holder Service in Vietnam?
Airseaglobal Group will take responsibility for the following work:
- Represent your company in all procedures with the Ministry of Health to get the Registration number of medical devices.
- Issue authorization letter for Vietnamese Distributors
- Consulting on medical devices classification
- Register medical devices circulation number.
- Take responsibility for guaranteeing that the registration number of medical devices is consistently valid throughout the cooperation process.
- Support manufacturers in the process of exchanging, negotiating, and signing contracts with importers.
- Monitor the regulations to update any changes or new regulations that apply to your product. Rapidly and precisely update the changes to adjust and supplement dossiers to maintain the circulation registration number of medical equipment.
- Keep track of trading activities and communicating between the producer and the designated distributors in Vietnam.
- Airseaglobal enables manufacturers to easily connect with potential distributors (~3000 distributors) thanks to our customer network throughout Vietnam.
- Provide an end-to-end logistics service to deliver goods from your warehouse to your customers throughout Vietnam.
Airseaglobal Group’s Profile: click here
Foreign customers using Airseaglobal’s Marketing Authorisation Holder services:
With a team of experienced consultants and a high sense of responsibility at work, Airseaglobal Group is always committed to providing customers with quality, reliable services and comprehensive, innovative solutions for customers’ problems. GUARANTEE TO GET IMPORT LICENSES PROFESSIONALLY – SHIPPING AND CUSTOMS DECLARATION OF HIGH QUALITY.
With more than 12 years of experience in consulting licenses for medical devices, cosmetics, dietary supplements + Professional international shipping Air/Sea (WCA member #73213), and high-quality customs declaration. In addition, Airseaglobal Group also has courses to train import-export staff, provides the best import-export staff for customers, and supports customers to buy and sell goods through a network of more than 20 Facebook groups + 16 largest Zalo groups in the country. Airseaglobal Group accounted for 32% of the service market share across the country in supporting services for medical equipment, cosmetics, and dietary supplement companies.
Airseaglobal Group is not only a licensing consulting company but also a forwarder having more than 12 years of experience in international transportation and customs clearance of goods (especially medical equipment, cosmetics, and dietary supplements), is 1 of the 200 largest professional shipping companies in Vietnam of the World Cargo Alliance (WCA) ID number: 73213
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AIRSEAGLOBAL GROUP JOINT STOCK COMPANY
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Address: Room 2412-2414 Eurowindow Building, 27 Tran Duy Hung, Trung Hoa Ward, Cau Giay District, Ha Noi City, Vietnam – Ho Chi Minh City, Hai Phong, Da Nang, Bac Ninh Branch
Website: https://thutucnhapkhauthietbiyte.com.vn/ https://airseaglobalgroup.com.vn/