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Regulatory Affairs Consulting Services in Vietnam
We offer complete regulatory affairs support in Vietnam, including DAV submissions, in-country representation, and tailored regulatory solutions for life sciences and healthcare industries.
Services We Offer
Vietnam Regulatory Affairs Outsourcing & Solutions
Vietnam’s got close to 100 million people and the healthcare market here’s been moving quick in the last few years. If you’re trying to get a product in, there’s the forms, the approvals, a few steps that don’t always run the same way every time. It helps a lot to have someone local who already knows the process — the language bits, which desk to send what to, and how to keep things from stalling. That way, you’re not stuck waiting longer than you need to before it’s out there.
Vietnam Healthcare Regulatory Affairs Outsourcing Market & Solutions
Vietnam’s growing life sciences scene is driving demand for local expertise. The Vietnam healthcare regulatory affairs outsourcing market offers end-to-end support—from planning and translations to dossier prep, submissions, and approvals—making regulatory solutions faster and easier for businesses.
We start by checking how the Vietnam healthcare regulatory affairs outsourcing market is shaking out — tallies, timelines, what’s working right now.
Next, we figure out the right path for you: which submissions to prepare (drug or device), which formats (ACTD, CTD), and who you need to talk to.
Then comes the paperwork — translated, formatted, double-checked. That means everything from dossier prep to regulatory solutions that adapt to what the authorities expect today.
We don’t just sit behind a screen. We team up with trusted locals — your Vietnam regulatory affairs and submission services arm on the ground — handling submissions, follow-ups, and any curveballs that pop up.
We don’t just sit behind a screen. We team up with trusted locals — your Vietnam regulatory affairs and submission services arm on the ground — handling submissions, follow-ups, and any curveballs that pop up.
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 Timelines in Vietnam
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.
| Products | Timelines |
|---|---|
| New Pharmaceuticals | 9–12 months |
| Generics | 6–9 months |
| Medical Devices (Class A) | 7–10 working days |
| Medical Devices (Class B to D) | 6–12 months |
| Cosmetics | 2–4 weeks (notification) |
| Nutritional/Supplements | 3–5 months |
| Biologics | 9–15 months |
| Veterinary Products | 6–10 months |
Why Choose Artixio as Your Regulatory Consultant in Vietnam?
Our team works on the ground with the Drug Administration of Vietnam (DAV), combining local know-how with global compliance standards to get your product approved—fast and without unnecessary back-and-forth. Talk to our Vietnam regulatory affairs consultant today for a seamless approval process.
FAQs
1. Is a legal agent required in Vietnam?
2. What is the validity period of a Market Authorization?
3. Can I register multiple products under a single license in Vietnam?
4. Are clinical trials mandatory for drug approval in Vietnam?
5. Do food supplements with herbal ingredients need special clearance?
Still Have Questions ?
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