Introduction

Vietnam’s social development in recent years has required the improvement of the quality of health care services for the Vietnamese people. Consequently, manufacturing and trading medical devices in Vietnam has now emerged as one of the country’s top growing business fields for domestic and foreign investors.

With these developments in mind, MedNovum’s legal and medical experts recognize the necessity and demand of manufacturers and importers for a professional and high-quality consulting service. This is the reason and purpose of MedNovum’s establishment.

Since 2017, the introduction of Decree No. 36/2016/ND-CP regulating medical devices has created a harmonious legal environment between Vietnam and ASEAN countries, with such regulations being like those of developed countries.

MedNovum employs a team of lawyers, doctors, master’s-degree holders, and lecturers working in hospitals and medical universities, who have many years of consulting experience in importing, publishing and registering medical devices. MedNovum will be your reliable companion for a successful approach to the potential market of Vietnam’s medical device field.

MedNovum Achieved ISO 9001:2015 Quality Certification for Management System

Operation fields:

Marketing Authorization Holder Service

Marketing Authorisation Holder service: MedNovum shall be the representative for Marketing Authorisation Number of medical devices for Owners – Also known as MA Holder. Issuing authorization letter for Vietnamese Distributors.

To Classify Medical Devices

Medical devices classification is an important procedure to circulate and distribute medical devices within the territory of Vietnam. According to current law, Decree 36/2016/ND-CP of the Government defined that medical devices shall be classified into 4 classes, which are A, B, C, and D depending on the possible levels of risk of medical devices.

To translate Medical devices documents

Translation team of MedNovum are translators and editors who are lawyers, doctors, physicians with master degree of medicine, lecturers with years of experience in the field of medical and work for top domestic and foreign hospitals or universities as well as freelancers who are top experts in medical field would bring satisfaction to customers…

To Consult on proclamation and circulation registration of medical devices

Medical devices proclamation and circulation registration are compulsory procedures when an organization wishes to distribute medical devices within the territory of Vietnam. However, this procedure is quite complicated and might take much time in completing dossiers as well as other procedures related to Government Agencies. Therefore, organizations with no experience in processing dossiers usually got their dossiers returned back and lost business opportunities.

To Support Importing and Distributing Medical Devices

Organizations specialize in import and trade medical devices must have import license in order to trade medical devices. However, the process and method take lots of time and effort to be done. Therefore, MedNovum would like to provide the most professional service in consultation as well as solution to import and distribute medical devices throughout the country.

Core team