Vietnamese medical device market is the 8th largest market in Asia-Pacific region with a market size of 1.7 billion USD, accounting for 0.4% of the worldwide market share. With a compound annual growth rate of 10.2%, Vietnam is considered as one of the fastest-growing markets in the region.
In addition, the policy of the development of medical infrastructure is an opportunity for foreign manufacturers to export and distribute medical devices to the Vietnamese potential market.
Medical devices regulations in Vietnam
The Department of Medical Equipment and Health Works (DMEHW), under the Ministry of Health (MOH), is the regulatory body that governs the registration and approval of all medical devices in Vietnam. Medical devices are mainly regulated by:
- Decree No. 98/2021/ND-CP on management of medical devices. This Decree takes effect from January 1, 2022.
- Circular 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.
- Management of prices of medical devices: Chapter VI, Session 2, Article 43, 44, 45 in Decree No. 98/2021/ND-CP on management of medical devices.
- Circular No. 30/2015/TT-BYT import of medical equipment. This Circular takes effect from 2015 and expires on December 31, 2022.
The medical devices distribution process for the company that has no representative office in Vietnam
For manufacturers that has no representative office in Vietnam, the process of distributing medical device into the Vietnamese potential market is as follows:
Step 1: Manufacturer appoints an commercial representative in Vietnam that is authorized as Marketing Authorisation Holder in this country.
Step 2: Carrying out registration procedures to the competent authority in Vietnam: medical devices classification, import license and declaration of applied standards/registration number for medical devices.
Step 3: Promotion and distribution of medical devices into Vietnam.
MedNovum – The pioneer in Marketing Authorisation Holder Service in Vietnam
As marketing authorisation holder (MA Holder) for manufacturer in Vietnam, MedNovum will take responsibility and represent to work with the Ministry of Industry and Trade Health in activities:
- Be the representative for Marketing Authorization Number of medical devices for Owners
- Issue authorization letter for Vietnamese Distributors
- Take responsibility for maintaining the compliance status of marketing authorization numbers and submitted dossier at all times, which will seamlessly accommodate changes in Vietnamese laws and engage business continuity;
- Support manufacturers to approach easily more than 600 potential importers and distributors thanks to MedNovum’s customer network in Vietnam
- Classifying medical devices
- Register medical devices
- Support exchanging informatuon and communicating between the manufacturer and the appointed Distributor in Vietnam.
- Monitor regulations to alert you to any changes or new regulations applicable to your product
5 reasons to choose MedNovum as Marketing Authorisation Holder in Vietnam
Time – saving: You can promote your business right away without waiting for legal procedures related to marketing authorization code. This procedure could take up to 4 months.
Cost savings: You don’t have to pay for setting up a representative office, managing a team in Vietnam and saving the cost of performing procedures many times with many different importers.
Professional service: Professional with extensive experience in the fifield of medical devices, strictly comply with the laws of Vietnam, legal consultancy service,…
Be a partner of the world’s leading companies: MedNovum is the pioneers in Marketing Authorisation Holder service in Vietnam and is chosen as a partner by the world’s leading manufacturers such as Medtronic, Fujifilm, Waters Corporation, Delcon SRL, Hans Biomed, Beckman Coulter, Stryker, Streck,…
Easily approach to importers/distributors: Approach freely more than 600 Distributors of medical devices who are currently MedNovum’s customers in Vietnam.
Should you need more information about this service, please do not hesitate to contact us via email: info@mednovum.com.vn or immediately call our hotline +84 28 3911 1551, we will contact you within 24 hours to answer your questions and free consultation.
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