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Regulatory Affairs Services in Vietnam

Strategic solutions for product approvals across the pharmaceuticals, MedTech, nutrition, cosmetics, biologics, and veterinary industries with support from a trusted Regulatory Affairs Consultant in Vietnam.

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Vietnam Regulatory Affairs Support

With a population of nearly 100 million, Vietnam is an important market in Southeast Asia for pharmaceuticals, medical technology, nutrition, and wellness products. The country’s expanding healthcare sector offers strong commercial opportunities. To enter this market, companies must follow local procedures and regulatory requirements. Working with professionals offering regulatory affairs consulting services in Vietnam can support accurate documentation, local coordination, and timely product registration.

Regulatory Authorities in Vietnam

Vietnam’s regulated industries are supervised by multiple agencies depending on the product category. Regulatory affairs in Vietnam involve accurate product classification, preparation of locally compliant documentation, and coordination with a licensed in-country agent to meet the necessary approval requirements.

Drug Administration of Vietnam (DAV): It manages registration of pharmaceuticals and biologics. DAV requires ACTD/CTD-format dossiers, Vietnamese translations, and GMP/CPP compliance.

Vietnam Food Administration (VFA): VFA oversees food supplements, fortified products, and nutritionals. The products with health claims may require clinical evidence or additional agency approvals.
Ministry of Health’s Infrastructure and Medical Device Administration (IMDA): Formerly known as Department of Medical Equipment and Construction (DMEC), IMDA is a specialised department for Medical Devices registration under Ministry of Health (MOH). The medical devices are classified (Class A to D) and processed through the Vietnam Medical Device Portal.
Department of Animal Health: It is responsible for veterinary drugs, vaccines, and animal nutrition products.
National Institute of Drug Quality Control (NIDQC): They may perform quality testing or request certificates depending on the product category.

Pre-Submission Preparation

  • Classify the products correctly to determine the regulatory pathway and the responsible authority (e.g., DAV, VFA, MOH, or BAI).
  • Appoint a local legal entity or Marketing Authorization Holder (MAH) before the submission as the foreign manufacturers are not permitted to file directly.
  • Prepare the supporting documents such as GMP certificates, Free Sale Certificates (FSC), and manufacturer authorizations in advance for authentication.

Dossier Compilation and Localization

  • Technical dossiers should follow the appropriate format, i.e., ASEAN Common Technical Dossier (ACTD) for pharmaceuticals and biologics, Common Submission Dossier Template (CSDT) for medical devices, and simplified templates for cosmetics and food supplements.
  • All submission materials, including product labels and inserts, are required in Vietnamese language.
  • For certain categories, regulatory authorities in Vietnam may request product samples or additional quality documentation at the time of submission or evaluation.

Submission and Coordination

  • Applications are submitted through DAV’s e-Portal or via physical delivery depending on the product category.
  • Registration fees must be paid at the time of submission with the proof.

Review and Clarification Process

  • Technical reviews are conducted by the relevant division (e.g., DAV for pharmaceuticals, VFA for nutritionals), which may involve external laboratories like National Institute of Drug Quality Control (NIDQC) or Directorate for Standards, Metrology and Quality (STAMEQ) for additional verification.
  • Clarification requests are common and may address formulation details, GMP site compliance, test results, or labeling inconsistency.

Product Approval

  • Upon successful review, the product receives a Certificate of Product Registration (CPR), Notification Confirmation (for cosmetics), or Import License (for devices).

Post-Market Responsibilities

  • Post-approval responsibilities may include pharmacovigilance (for drugs), change notification filings, and product recalls or inspections initiated by the Ministry of Health.

Product Approval Lifecycle

Timelines may extend if translation, classification, or local representation requirements are not met at the time of submission. Working with compliance consulting regulatory affairs experts in Vietnam can help address these gaps early and keep the registration process on track.

ProductsTimelines
New Pharmaceuticals9–12 months
Generics6–9 months
Medical Devices (Class A)7–10 working days
Medical Devices (Class B to D)6–12 months
Cosmetics2–4 weeks (notification)
Nutritional/Supplements3–5 months
Biologics9–15 months
Veterinary Products6–10 months

Why Artixio?

5000+ regulatory submissions handled across Southeast Asia
100+ pharmaceutical, device & supplement brands supported
ACTD, CTD, and CSDT dossiers customised to DAV & MOH formats
35+ years of regulatory experience in ASEAN markets
Vietnamese translation, MAH, and post-approval services under one roof

Artixio helps with local insight, regulatory accuracy, and full-cycle support and ensures that your products enter the market without delays or compliance risks. Talk to our Vietnam regulatory affairs consultant today for a seamless approval process.

FAQs

1. Is a legal agent required in Vietnam?
Yes, foreign manufacturers cannot directly register products with the DAV or other agencies. A Vietnamese legal representative or Marketing Authorization Holder (MAH) is required for all submissions.
Most registrations are valid for five years. Renewal applications should be submitted at least six months before the registration expiration to avoid a lapse in market presence.
No, each product must have its own registration dossier and Market Authorization. Product line extensions or different formulations require separate filings or variation submissions.
It is not always required. For generics and drugs with prior international approvals, bioequivalence data may suffice. New molecules, biologics, or locally untested therapies may require clinical data or bridging studies.
Yes, traditional or herbal components are reviewed for safety and local acceptability. Some may be restricted or require additional documentation or testing.

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