Strategic Regulatory Partner for Success in Vietnam

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Pharma Wizard Vietnam Regulatory Services

With rising demand for quality healthcare and a fast-growing economy, Vietnam offers a promising market for foreign drug and medical device manufacturers. All medicinal products imported into Vietnam require approval from the Ministry of Health (MOH) and the Drug Administration of Vietnam (DAV), while medical devices are regulated by the Department of Medical Equipment and Health Works (DMEHW).
Navigating communication with multiple regulatory bodies can be challenging—especially for manufacturers unfamiliar with the Vietnamese regulatory system.
As a trusted global regulatory partner, Pharma Wizard helps foreign manufacturers interpret and comply with Vietnam’s regulatory requirements, offering guidance on regulatory strategy and execution for successful market authorization. With streamlined processes and quicker submission timelines, we offer regulatory consulting services in Vietnam for

Industries We Serve in Vietnam

Medical Devices Regulatory Support in Vietnam

Vietnam’s medical device market is experiencing rapid growth and has become one of the country’s most dynamic sectors. Medical devices are regulated by the Department of Medical Equipment and Health Works (DMEHW), operating under the Ministry of Health (MOH). To enter the Vietnamese market, foreign manufacturers are required to appoint a Local Authorized Representative in Vietnam to facilitate the medical device registration process and ensure compliance with local regulations. Pharma Wizard offers end-to-end regulatory support, including representation, registration strategy, dossier preparation, and submission, to help manufacturers successfully obtain market authorization for their medical devices in Vietnam.

Cosmetics Regulatory Support in Vietnam

Cosmetics play a key role in enhancing natural beauty and physical appearance. Growing awareness around personal grooming, combined with Vietnam’s aging population and rapid urbanization, is significantly driving the expansion of the cosmetics market. Additionally, there is a notable shift in consumer preferences toward natural and organic products, leading to increased cosmetic spending. The demand for clean-label, plant-based ingredients is accelerating the growth of the industry and creating a strong need for Vietnam cosmetic registration. As a global regulatory partner, Pharma Wizard provides comprehensive support for cosmetic product registration in Vietnam, helping manufacturers meet all compliance requirements efficiently and successfully enter the market.

Food Supplements Regulatory Support in Vietnam

Food supplements in Vietnam are regulated by three primary authorities: the Ministry of Health (MOH), the Ministry of Agriculture and Rural Development (MARD), and the Ministry of Industry and Trade (MOIT). These agencies coordinate under Decree No. 38/2012/ND-CP, which provides regulatory guidance for implementing the provisions of the Law on Food Safety (LoFS). Health supplements in Vietnam can be produced in various forms—including soft gels, pellets, tablets, granules, powders, and liquids—and are typically intended for consumption in measured, smaller doses. As a global regulatory partner, Pharma Wizard assists manufacturers in navigating Vietnam’s multi-agency regulatory framework. We provide comprehensive support for product classification, dossier preparation, registration, and post-approval compliance to help ensure smooth market entry and regulatory approval for food supplements

Pharma Wizard Offerings – Vietnam

Strategic Regulatory Affairs Consulting
Regulatory Intelligence Services
Registration Pathways and License Management
Dossier Preparation, Review, and Management
Regulatory Labeling Support
Labeling and Advertising Approvals

Pharma Wizard Advantages

Strong local health authority relationships – with Drug Administration of Vietnam (DAV) and Vietnam Food Administration (VFA)
Expert regulatory team with proven experience and domain expertise
Proactive and collaborative engagement approach
Fast turnarounds for accelerated market access
Continuous monitoring of Vietnam-specific legislation and regulatory guidelines to ensure full compliance

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Food & Food Supplements Product Services

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Sustainability Services