Introducing Mednovum

Introduction

The rapid growth of the medical device market in the Asian region has created increasing demands for quality, compliance, and international market readiness. Recognizing this need, MedNovum was founded with the goal of becoming a trusted partner connecting North American and European manufacturers with the high-potential medical device markets in Asia.

We provide comprehensive and professional services: from in-depth advice on market access and regulationsrequirements to risk management, product registration, legal representation (MAH/License Holder), and support for establishing legal entities across the Asian region. The MedNovum team—comprising lawyers, physicians, lecturers, and medical device experts with many years of experience in importation, notification, and registration of medical devices—stands by your side at every step.

MedNovum Achieves ISO 9001:2015 Certification for Quality Management Systems

Our Services

Registration service:

With a team of experts deeply knowledgeable in local regulatory requirements and extensive hands-on experience in medical device registration, MedNovum is willing to accompanie enterprises through every step — from document preparation to achieving results — ensuring a registration process that is accurate, efficient, and timely.

Circulation number entrustment service:

If businesses are concerned about the cost of establishing a legal entity in the target market, and do not want to entrust the exclusive market to a distributor, MedNovum offers a more flexible and optimal solution for businesses. With the presence of a reputable partner in the host country, MedNovum provides a circulation number entrustment representative service, supporting businesses in submitting registration applications as directed, while still ensuring proactive control of the market and products.

Regulatory compliance consulting services:

Language barriers and the complexity of local laws make it difficult for businesses to access the market. Don't worry, with MedNovum's specialized consulting service package, we ensure compliance for businesses from the market access stage to the post-sales management stage.

Key Personnel

NGUYEN TRUNG HIEU

Chairman
CEO – MedNovum Canada

Degree

Bachelor of Laws (Ho Chi Minh City University of Law, Vietnam)
Master of Laws (Ho Chi Minh City University of Law, Vietnam)
Lawyer (Ho Chi Minh City Bar Association, Vietnam)
Legal advice license in Ontario (Canada)

Experience

Advising domestic and foreign manufacturers and distributors on legal issues related to classification, registration, import and export and trade of medical equipment in Vietnam.
Advising multinational companies on investment, business, labor and compliance in Vietnam.

TRAN TIEN LAM

Manager

Degree

University Pharmacist (Hanoi University of Pharmacy, Vietnam)
Master of Pharmacy (Chosun University, Korea)

Experience

Research, management and consulting activities in the field of pharmaceuticals and medical devices since 2006
Extensive experience in clinical pharmacy, Pharmaceutical Economics - Marketing and medical equipment.

PHAM TIEN DUY

Deputy Director in charge of Legal Compliance Department

Degree

Bachelor of Laws (University of Economics and Law – Vietnam National University, Ho Chi Minh City, Vietnam)
Lawyer (Ho Chi Minh City Bar Association, Vietnam)

Experience: 05 years

HUYNH THI BICH TUYEN

Head of Medical Equipment Engineering and Classification Department

Degree:

Bachelor of Biomedical Engineering (Ho Chi Minh City University of Technology, Vietnam)
Classification of medical equipment (College of Medical Equipment Technology – Ministry of Health, Vietnam)

Experience: 15+ years

HOANG THU TRANG

Head of Translation Department

Degree

University Pharmacist (Hanoi University of Pharmacy, Vietnam)
Master (Tokyo University of Agriculture, Korea)

Experience:

Has many years of experience in research and project management in the field of medical devices and clinical pharmacy for many multinational companies and corporations.

NGUYEN THI MY HUE

Main Partner

Degree

Bachelor of Hotel Management (University of Finance - Marketing, Vietnam)

Experience: 06 years

PEACH PEARL TUYET NHI

Associate

Degree

Bachelor of Laws (University of Economics and Law – Vietnam National University, Ho Chi Minh City, Vietnam)
BA in Chinese Language (University of Social Sciences and Humanities – Vietnam National University, Ho Chi Minh City, Vietnam)

Experience: 05 years.