- Home
- >
- All Countries
- >
- Vietnam
Lifesciences Compliance Services in Vietnam
From compliance to success, comprehensive regulatory services for product market entry and maintenance.
Vietnam
We provide extensive regulatory services in all key life sciences industries which include Pharmaceuticals, Medical devices, beauty products, food supplements, Biologics and Veterinary. We ensure compliance in every stage of regulatory processes. Collaborate with us for your regulatory success.
Regulatory Authority in Vietnam
The Ministry of Health (MoH), Vietnam is the authority that oversees the regulation of pharmaceutical products. It is not only limited to pharmaceutical products but also involved in the regulation of cosmetics and food supplements as well. The Ministry of Health of Vietnam has several units under it governing the pharmaceuticals, cosmetics, food and other sectors that provide with the requirements needed to be complied for marketing a product.
The Drug Administration of Vietnam (DAV) looks after the pharmaceuticals including medicines, cosmetics & biologics whereas The Department of Medical Equipment and Construction (DMEC) deals with medical devices. The Vietnam Food Administration (VFA) is responsible for food supplements approval.
It is a must to gain a permit from The Drug Administration of Vietnam (DAV) before the marketing of all pharmaceuticals in the Vietnamese market. It is also required to meet the safety, quality concerning registration requirements and must also be in compliance with the regulation of registration of drugs in Vietnam. This is applicable for every product that decides to enter in the market unless it is exempted from the regulations by the concerned authority.
All these rules and regulations are put in place to ensure that each product entered into the market is not by chance but has earned its position through proper design, development and testing. This is strengthened with the GCP, GMP, GDP, GLP and all other relevant regulations that apply for product approval, market access and maintenance.
Artixio: Your First Step Towards Regulatory Success
Our services include but are not limited to regulatory operations, product registration, market research and market access, post market surveillance and maintenance activities, product lifecycle management, labeling, artwork, testing, regulatory intelligence and strategy as well as pre & post registration services.
Artixio’s subject matter experts are experienced in deep comprehension of the problems or challenges that may arise with your regulatory journey. We have our regional experts with 30+ years of experience to implement ways to overcome or simply omit them. We strictly stick to regulatory compliance which allows for lesser rejections and more approvals. Our team prioritizes safety and quality of the product which decreases the recall of the product once it has launched in the market.
Reason for Our Achievements
Advanced knowledge of our regional experts on regulatory requirements depending on the region, tailored regulatory solutions and strategies that we offer has been a great advantage and have always set Artixio’s and our client’s efforts to the regional health authorities’ expectations.
Artixio’s success and global recognition is from regular follow up of the mutable requirements of the health authorities, timely & strategic intervention and flexible approach according to our client needs and our keenness in bringing the product to the market that can make a positive change by improving the quality of life.
Our Regulatory Services in Vietnam
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Why Trust Us with Your Product?
Proven regulatory success in each stage for 5000+ products.
20+ years of regulatory compliance across all phases
Customised, flexible & regional regulatory support in 70+ markets
Experienced in various regulatory actions under MoH, Vietnam.
Accurate and timely submission of documents.
Timely intervention leading to faster approval of 100+ products.
Industries We Serve in the Vietnam
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
What happens if the product is showing non-compliance with the Vietnam MoH regulations?
Non-compliance of the product with the MoH Vietnam can lead to delayed registration and approval of the products, resubmission or re-evaluation of documents, inspection of existing methods and processes followed by company, product recalls and rejection, fines and other penalties.
Who regulates pharmaceuticals, medical devices, cosmetics, biologics, food and veterinary products in Vietnam?
The Drug Administration of Vietnam (DAV) regulates pharmaceuticals, cosmetics and biologics. Medical devices are governed by the The Department of Medical Equipment and Construction (DMEC), The Vietnam Food Administration for food supplements and Ministry of Agriculture and Rural Development (MARD) for veterinary products.
What is the process of approving a clinical research protocol in Vietnam?
After submitting the protocol developed by the principal investigator and the study sponsor to the Department of Science and Technology (DST) under MoH, it is reviewed by the Ethics committee and science Committee. MoH can respond within 60 working days after receiving complete protocol documents.
What is the role of DST?
The Department of Science and Technology, DST is responsible for the coordination of protocol review processes, monitoring the implementation of the trial, assessment and evaluation of the trial results as well as providing guidance for the trial.
How to report ADR in Vietnam?
In Vietnam, ADR is reported online to the The National Center of Drug Information and Adverse Drug Reactions Monitoring Centre (NDIADRMC) under Ministry of Health Vietnam. The ADR report form contains four sections which are on patient information, adverse events and product information, suspected medications and the information of the reporter.
Our Global Reach: Serving Life
Sciences Clients Worldwide
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
Insights from Artixio - Tips & Articles
Pharma Manufacturing Booms in
Hildalgo had good pharmaceutical infrastructure and supply chain capabilities, but with no foreign investment...
UK Releases Amendment &
In January 2025, MHRA UK released guidance on implementation of amendments to Medical Devices...
Artixio Announces Grant for
HYDERABAD, India - March 27, 2024 - Artixio, a leading compliance and commercial consulting...