Compliance tools
Check compliance with Vietnamese regulation
Look up the banned/restricted status of ingredients, and determine the public-hospital tender group (1–5) your medicine qualifies for.
Medibase compliance tools — at a glance
Medibase's tools are designed to compress the diagnostic and planning stages of foreign companies planning entry to the Vietnamese market. Ingredient screening, tender-group determination, expiry tracking and full-pathway impact simulation — all run against public Vietnamese regulatory data (laws, decrees, circulars, DAV/VFA/IMDA portals). These are not registration services — dossier compilation and filing remain with the sponsor or its appointed local partner. The tools' output accelerates internal decisions and establishes a defensible starting point for negotiations with the appointed partner.
| Tool | Use case | Input | Output | Primary basis |
|---|---|---|---|---|
| Ingredient & Substance Checker | Pre-check banned/restricted status of a cosmetic or pharmaceutical ingredient | List of INCI names or CAS numbers | Annex II (banned) / III (restricted) hits, max allowed concentration, warning statement requirements | ASEAN CD, Circular 06/2011/TT-BYT |
| Tender Group Calculator | Determine which of Groups 1–5 a product qualifies for in public-hospital tenders | Manufacturing site GMP tier, SRA/EMA approval status, product category | Qualifying group + citation to source article | TT 15/2019, TT 09/2024 |
| Expiry / Renewal Calculator | Compute SĐK expiry, 3-month automatic-extension threshold, renewal-application deadlines | SĐK issue date, product category, current filing status | Timeline of deadline milestones, automatic-extension eligibility | Law 44/2024, TT 12/2025, TT 32/2026 |
| Regulatory Impact Simulator | Full-pathway impact assessment for market authorisation (multi-step wizard) | Product profile, country of origin, target launch date | Milestone-by-milestone cost, time, and regulatory requirements | Composite |
Each tool is most valuable when paired with the corresponding regulatory guide (drug registration, medical-device registration, cosmetic notification, drug tendering) — the tool answers "what does the rule say for my product?"; the guide answers "how does the rule work in practice?".
Frequently asked questions
What tools does Medibase offer for foreign companies entering the Vietnamese market?
Four instruments: an Ingredient & Substance Checker, a Tender Group Calculator, an Expiry / Renewal Calculator, and a step-by-step Regulatory Impact Simulator wizard covering the full marketing-authorisation timeline. See the comparison table above for details.
Does Medibase file registration dossiers on behalf of companies?
No. Medibase is a Regulatory Technology (RegTech) reference and tools platform, not a registration-services agency. The tools accelerate diagnostic and planning stages; dossier compilation and DAV/IMDA/VFA submission remain the responsibility of the applicant or its appointed local partner.
Are Medibase's tools free to use?
Yes. All tools listed on /tools/ are free to use without registration. Medibase does not charge per query and does not require account creation.
How does Medibase handle the transition to Circular 32/2026 on 1 October 2026?
The Expiry / Renewal Calculator and the Regulatory Impact Simulator both incorporate Circular 32/2026/TT-BYT provisions effective from 1 October 2026 — the consolidated-application mechanism, the deferred-CPP option, the expanded MiV-N variation categories (11 → 13), the one-month reconsideration pathway, and the explicit 5-year data exclusivity for new drugs. Full analysis at the change-analysis article.
Do the tools cover medical devices, cosmetics, and food supplements — or only pharmaceuticals?
The Ingredient Checker covers cosmetics (ASEAN CD) and pharmaceutical excipients. The Tender Group Calculator applies to pharmaceuticals for public-hospital procurement. The Expiry Calculator handles drug SĐK and medical-device số lưu hành (indefinite after Decree 07/2023). Food supplement (TPBVSK) and food self-declaration are covered in the reference guides at /supplement/ and /food/ — self-declaration for food is administratively lightweight and does not warrant a calculator layer.
What data sources do the tools use?
ASEAN Cosmetic Directive (Annex II/III), the Ministry of Health prohibited-substance annexes (Circular 06/2011/TT-BYT and amendments), the tender-group matrix (TT 15/2019 as amended by TT 09/2024), Law 44/2024/QH15, Decree 163/2025/NĐ-CP, Circular 12/2025/TT-BYT and Circular 32/2026/TT-BYT. All citations are surfaced in the legal register.