Pure Global's ASEAN MedTech Insights: Navigating Vietnam's Mandatory Declaration for Class A Medical Devices, Not an Exemption

Many MedTech manufacturers believe that low-risk, Class A medical devices are exempt from registration in Vietnam. This common misconception can lead to significant import delays, financial penalties, and blocked market access, demonstrating how a small misunderstanding of local regulations can derail an entire business strategy. This episode of ASEAN MedTech Insights dives deep into the realities of Vietnam's regulations under Decree 98/2021/ND-CP. We clarify that Class A devices are not exempt but instead require a mandatory 'Declaration of Applicable Standards'. We break down this streamlined but crucial process, outlining the specific steps and documents needed to ensure your low-risk devices can be legally imported and sold. --- **Case Study:** Imagine your first large shipment of sterile bandages is stuck at Ho Chi Minh City customs. Your distributor can't clear it, and you're facing daily storage fees that are eroding your profit margin. The reason? A missing declaration receipt number, a document you thought you didn't need for a 'simple' Class A device. This single oversight has halted your entire market entry, frustrating your local partners and putting future orders at risk. --- **Key Takeaways:** 1. Why is the term 'exempt' dangerously misleading for Class A devices in Vietnam?. 2. What is the "Declaration of Applicable Standards" and which authority reviews it?. 3. Which specific government decree governs all medical device classes in Vietnam today?. 4. What are the five essential documents you absolutely need for the Class A declaration process?. 5. How can a simple administrative error at the declaration stage block your product at customs?. 6. What is the final "receipt number" and why is it critical for your Vietnamese distributor?. 7. Is an ISO 13485 certificate optional or mandatory for even the lowest-risk devices?. --- At Pure Global, we specialize in demystifying these local nuances. Our end-to-end regulatory consulting solutions combine local expertise with advanced AI to streamline market access across ASEAN and more than 30 markets worldwide. Don't let regulatory hurdles block your expansion. To ensure your MedTech products, from Class A to Class D, meet all local requirements efficiently, contact us at [email protected] or visit https://pureglobal.com/.

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