MOH Vietnam Medical Device Registration
With a population nearing 100 million and rapid economic growth, Vietnam's healthcare industry is expanding, bolstered by significant government investment and incentives. The high dependency on imported medical devices positions Vietnam as a lucrative market for international manufacturers seeking to enter or expand their presence in Southeast Asia.
Aligning with Vietnam's MOH Regulations
Regulatory Authority
Pure Global can assist with Vietnam's medical device registration, ensuring MOH approval to sell in the Vietnamese market.
Classification
Vietnam categorizes medical devices into four classes (A to D) based on risk, with Class A representing the lowest risk. Understanding this classification is crucial for determining the regulatory pathway and requirements for market entry.
Key Requirements
To market in Vietnam, foreign manufacturers must:
- Appoint a Marketing Authorization Holder (MAH) to represent them in regulatory submissions and interactions with Vietnamese authorities.
- Compile a comprehensive technical dossier for submission to the DMEC for Class B, C, and D devices, or notify the Provincial Department of Health for Class A devices.
Tailored Support for Market Entry
Leverage our expertise to navigate Vietnam's regulatory landscape:
Assistance with product classification and determination of the appropriate regulatory pathway.
Support in compiling the necessary technical dossier for DMEC submission.
Acting as your Marketing Authorization Holder (MAH), managing the registration process and ensuring compliance with post-market regulations.
We Provide Access To 28+ Markets Worldwide
Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.