Registered number of medical equipment circulation in Vietnam

MEDICAL EQUIPMENT CIRCULATION NUMBER SERVICE IN VIETNAM

Medical equipment market (“Medical Equipment”) Vietnam is the eighth largest in the Asia Pacific region with a market size of 1.7 billion USD, accounting for 0.4% of the world market share. With a compound annual growth rate (CAGR) of 10.2%, Vietnam is considered one of the fastest growing markets in the region.

In addition, with the policy of promoting the development of healthcare infrastructure, this is an opportunity for foreign companies/manufacturers to export and distribute medical equipment to the potential market in Vietnam.

Medical device legislation in Vietnam

The Department of Medical Equipment and Health Works (DMEHW), under the Ministry of Health (MOH), is the regulatory agency for the registration and approval of all medical equipment in Vietnam. Medical equipment is regulated by DMEHW according to the following documents:

Decree No. 98/2021/ND-CP on medical equipment management – Have effective from January 1, 2022.
Circular No. 30/2015/TT-BYT regulating the import of medical equipment – effective from 2015 and will expire on December 31, 2022.

Medical equipment distribution process for companies that do not have representative offices in Vietnam

For companies/manufacturers that do not have a representative office in Vietnam, the process to distribute medical equipment into the potential Vietnamese market is as follows:

Step 1: The Company/Manufacturer designates an authorized commercial representative in Vietnam to be the name of the circulation number.

Step 2: Conduct and comply with the registration process of the competent authority in Vietnam: classify, apply for import license and declare applicable standards/register circulation number of medical equipment.

Step 3: Promote and distribute medical equipment in Vietnam.

MedNovum – The pioneer in registering medical equipment circulation numbers in Vietnam

MedNovum, as the representative holding the medical equipment circulation number (also known as Marketing Authorisation Holder - MA Holder) for the Company/Manufacturer in Vietnam, will be responsible and represent transactions with the Ministry of Health in the following activities:

Responsible for maintaining compliance status of medical device registration number and resubmitting documents when Vietnamese laws change to ensure business continuity.
Support Companies/Manufacturers to reach more than 600 potential Importers and Distributors thanks to MedNovum's Customer network in Vietnam.
Classification of medical equipment
Registering medical equipment circulation number
Support information exchange and communication between the Company/Manufacturer and designated Distributor in Vietnam.
Monitor the situation after medical equipment is authorized and introduced into the Vietnamese market.
Monitor and report new regulations for medical equipment of the Company/Manufacturer.

CALL NOW FOR CONSULTATION: +84 28 3911 1551

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