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DAV Compliance & Market Entry Consulting in Vietnam

 We help life sciences companies meet DAV compliance guidelines, secure local market authorization, and navigate Vietnam’s healthcare requirements with in-country expertise.

Vietnam

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Compliance & Market Entry Consulting in 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 Authorities 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: Vietnam Healthcare Compliance Consulting

  • We guide life sciences teams in Vietnam through three main phases: getting approval, staying compliant post-launch, and keeping your product safe on the market.
  • Need local market authorization support or a compliance consulting company in Vietnam to handle your DAV submission? We’re the go-to partner.
  • Prefer hands-on support? We’re your in-country compliance representation Vietnam—local, available, and practical.
  • Some clients ask us for specific help like dav compliance guidelines consulting or compliance strategy planning for DAV, while others want full-service—from submission to getting a local authorised agent onboard.
  • Our team? Decades of real-world Vietnam experience. We know where things trip up, we spot red flags early, and we build strategies that align with Vietnam healthcare compliance consulting standards to speed up approvals and reduce recalls.

How Artixio Delivers Compliance Success in Vietnam

Success in Vietnam’s compliance process isn’t about ticking boxes — it’s about knowing how the Drug Administration of Vietnam (DAV) works and staying ahead of its changing guidelines. Our experience comes from years of helping companies move smoothly from application to approval.

What gives our clients an edge:

  • Local insight – Our experts understand DAV submission processes in detail.
  • Tailored compliance strategy – Designed for your product’s specific requirements.
  • In-country representation – On-ground support for faster market entry.
  • Quick adaptability – Responding fast to any shift in DAV compliance guidelines.
  • Full-cycle support – Covering pre-launch, post-market checks, and lifecycle maintenance.

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
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Why Trust Us For Life Sciences Compliance Consulting for Vietnam?

Proven regulatory success in each stage for 5000+ products.
Full product compliance consulting in Vietnam – From launch to post-market lifecycle support.
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.
In-country compliance representation Vietnam – Direct presence to handle processes on the ground.
Proven DAV submission experience – 20+ Years of working with the Drug Administration of Vietnam.
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FAQs

Do I need a local authorised agent for Vietnam market entry?

Yes, most products require a local authorised agent to interact with the health authorities. We provide local authorised agent services so you don’t have to set up a local office just for compliance.

We work with pharmaceuticals, medical devices, cosmetics, nutrition, biologics, and veterinary products. Whether you need Vietnam healthcare compliance consulting or product compliance consulting in Vietnam, our team has handled similar cases before.

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.
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.
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.

Required documents vary by product but usually include technical files, quality certifications, safety data, and test reports. We offer DAV compliance guidelines consulting to make sure your documents meet the current standards.

Get started with product approval

Industries We Serve in the Vietnam

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Request a free consultation for your industry

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