Simplifying Medical Device Registration for Vietnam's Growing Market

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.

Device Classification and Regulatory Pathways

Aligning with Vietnam's MOH Regulations

Regulatory Authority

The Department of Medical Equipment and Construction (DMEC) within the Ministry of Health (MOH) oversees the registration and licensing of Class B, C, and D medical devices in Vietnam. The process includes issuing import licenses and Certificates of Free Sale. For Class A devices, the Provincial Department of Health manages the notification process, streamlining entry for lower-risk products.

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.
How We Can Help

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.

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