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 it as a lucrative market for international manufacturers seeking to enter or expand their presence in Southeast Asia through Vietnam medical device registration.
Aligning with Vietnam's MOH Regulations
Regulatory Authority
Medical devices sold in Vietnam are regulated by the Department of Medical Equipment and Construction (DMEC) under the Ministry of Health (MOH). Pure Global can assist with Vietnam's medical device registration and act as your Marketing Authorization Holder (MAH), 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.
Frequently
Asked Questions
What is the regulatory authority for medical device registration in Vietnam?
The Ministry of Health (MOH) is the regulatory authority responsible for the registration and approval of medical devices in Vietnam. They oversee the compliance and regulatory requirements for market entry.
How are medical devices classified in Vietnam?
Medical devices in Vietnam are categorized into four classes (A to D) based on their risk level, with Class A representing the lowest risk and Class D the highest. This Vietnam medical device classification determines the regulatory pathway and specific requirements for market entry. They oversee the compliance and regulatory requirements for market entry.
What are the key requirements for foreign manufacturers to market medical devices in Vietnam?
Foreign manufacturers must appoint a Marketing Authorization Holder (MAH) to represent them in regulatory submissions and interactions with Vietnamese authorities. According to Vietnam medical device regulations, they also need to compile a comprehensive technical dossier for submission to the Department of Medical Equipment and Construction (DMEC) for Class B, C, and D devices, or notify the Provincial Department of Health for Class A devices as part of the Vietnam medical device registration process.
What is the role of the Marketing Authorization Holder (MAH) in Vietnam's medical device registration process?
The Marketing Authorization Holder (MAH) acts as the representative for foreign manufacturers in regulatory submissions and interactions with the Vietnamese authorities. The MAH ensures that the necessary documentation and compliance requirements are met for Vietnam medical device registration and market entry of medical devices in Vietnam.
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