Our Lasted Insights
How does Vietnam compare 64 coronary stents in a single national tender?
September 21, 2026
As one of the first medical device categories entering national centralized procurement, coronary drug eluting stents provide an interesting case study on how healthcare systems attempt to balance: ✅ Clinical evidence✅ Quality requirements✅ Regulatory approvals✅ Competition✅ Patient access The proposed approach reviews 45 Sirolimus-coated stents from 35 manufacturers and 19 Everolimus-coated stents from 9 manufacturers,
Vietnam-Korea Medical Device Cooperation: A Strong Signal for Korean Manufacturers
September 21, 2026
The recent cooperation framework between Vietnam’s Medical Device Administration (VIMDA) and Korea’s Medical Device Safety Bureau (MFDS) may not create immediate regulatory shortcuts, but it sends an important message to the medical device industry. The agreement goes beyond a simple exchange program. It establishes a structured platform for cooperation covering medical device registration, quality systems,
Big News for Vietnam’s Cosmetics Industry: The Window to Shape Future Rules is OPEN
September 21, 2026
The MoH has released a landmark draft Decree on Cosmetics Management. This isn’t just a technical upgrade; it changes how products get registered, monitored, and marketed across Vietnam. Here are the 5 changes that matter most: 1️⃣ FULLY AUTOMATIC NOTIFICATION: The new system issues a notification number within 3 working days. If the clock runs
Vietnam Officially Releases the Apostille Implementation Plan – A Major Breakthrough for Regulatory Submissions
September 21, 2026
The Government of Vietnam has officially issued the national plan to implement the Apostille Convention. This marks a significant regulatory milestone, paving the way for eliminating consular legalization for public documents exchanged between Apostille member states. Four Key Implementation Phases 1️⃣ Communication & Awareness (Effective immediately) The Ministry of Foreign Affairs (MOFA) and related agencies
Vietnam Decree 37/2026/NĐ‑CP: A New Era for Product Labeling & Traceability
September 21, 2026
Vietnam’s latest decree reshapes how businesses must think about product labels and compliance. 🔑 Key Highlights 1️⃣ Dual Labeling: Physical labels remain mandatory, but electronic labels (E‑labels) are now officially recognized.2️⃣ Digital Integration: Labels can embed QR codes, RFID tags, and barcodes to provide instant access to product data.3️⃣ Risk‑based Traceability: High‑risk products must adopt
Huge Win for MedTech in Vietnam: Regulatory Streamlining under Decree 26/2026/ND-CP
September 21, 2026
Great news for the Medical Device industry! The Government has just issued Decree No. 26/2026/ND-CP, and it’s a game-changer for how we manage chemicals in healthcare. For years, the MedTech sector has navigated complex, overlapping regulations. This new Decree brings much-needed clarity and efficiency by confirming that the Ministry of Health (MOH) is the sole
Vietnam’s MedTech Procurement Shift: Unpacking Circular 57/2025/TT-BYT and the New Grouping Rule for Medical Device
September 21, 2026
Just before closing out the year, the Vietnamese Ministry of Health issued Circular 57/2025/TT-BYT on December 31, 2025. This critical document sets the stage for a new era in procurement, introducing detailed guidelines on classifying medical devices based on technical standards and quality. Just before closing out the year, the Vietnamese Ministry of Health issued
Are Refurbished Medical Devices Allowed To Be Imported Into Vietnam?
September 21, 2026
This is a common question from manufacturers and distributors exploring the Vietnam market.The short answer: not yet, in practice. Vietnam has issued two Government Decrees that allow the import of refurbished (remanufactured) goods in principle, based on Free Trade Agreements:Decree 77/2023/ND‑CP (CPTPP)Decree 66/2024/ND‑CP (EVFTA & UKVFTA) ⚠️ However, these decrees are framework-level only. They confirm
Your Brand, Your Risk: Choosing The Wrong Distributor Can Cost More Than Sales
September 21, 2026
Recently, the aesthetics industry has seen a familiar but costly scenario: A product marketed for years as suitable for mesotherapy (injection) was suddenly “clarified” by its local distributor—in writing—to be for topical cosmetic use only, as per its regulatory dossier. From a consulting perspective, this exposes a structural risk many foreign manufacturers underestimate—the loss of
Are You Giving Away Control of Your Product in Vietnam?
January 5, 2026
Are You Giving Away Control of Your Product in Vietnam? Many manufacturers let distributors hold their Market Authorization (MA) /license. While convenient, this can limit your control, flexibility, and long-term strategy. Strategic Separation = Market PowerBy appointing an independent third-party MAH (like Medflash), you keep regulatory ownership separate from sales. This unlocks: 1. Market Access