Successfully registering your medical device in Vietnam is the single most critical step to market entry. The process is intricate, governed by complex regulations from the Ministry of Health (MOH), including Decree No. 98/2021/ND-CP. A single error in your dossier or classification can lead to significant delays, rejections, and lost revenue.

Our team provides a complete, end-to-end registration service. We act as your dedicated regulatory partner, managing every detail from initial strategy to final approval. We ensure your submission is not just compliant, but flawlessly prepared to ensure the fastest possible review by the authorities.

Under Vietnamese law, a foreign medical device manufacturer must have a local entity to act as the legal Market Authorization Holder (MAH) or Local Authorized Representative (LAR).

Many companies make the critical mistake of assigning this role to their commercial distributor. This ties your legal registration asset to one commercial partner, creating significant business risk. If that relationship ends, you lose your license and must re-register your product from scratch, halting all sales.

Our independent License Holding service solves this. We act as your neutral, non-commercial, and fully-compliant Local Authorized Representative. This “de-links” your registration from your distributor, giving you complete control over your business.

Regulatory compliance is not a one-time event; it’s a continuous process. After your device is registered, you must maintain compliance through its entire lifecycle. New regulations emerge, changes to your device occur, and post-market responsibilities must be met.

For companies without a full-time local RA/QA department, managing these ongoing needs can be costly and overwhelming. Our Extra RA/QA Support service provides a flexible, cost-effective solution. We act as an extension of your team, providing expert support exactly when you need it.