Overview
Vietnam’s healthcare, pharmaceutical, and life sciences sectors are governed by a stringent, multi-layered, and frequently evolving regulatory framework, spanning investment conditions, product registration, professional standards, business ethics, and marketing practices. Even minor compliance failures may result in license suspension, product withdrawal, or exclusion from the market.
Nhat Nam Law LLC acts as a specialized legal adviser to healthcare and life sciences businesses, combining in-depth knowledge of Vietnamese law with practical experience in GxP standards and healthcare operations. We assist clients in achieving lawful market entry, maintaining long-term regulatory compliance, and expanding their activities in a sustainable and commercially viable manner.
Scope of services
Our Healthcare, Pharmaceuticals and Life Sciences Services include:
Market Access and Licensing
- Advising on and handling procedures for obtaining marketing authorizations (MA) for pharmaceuticals, active pharmaceutical ingredients (APIs), medical devices, and cosmetic product notifications;
- Assisting with licensing and operational approvals for private hospitals, specialized clinics, diagnostic laboratories, and GPP-compliant pharmacy chains;
- Advising on foreign direct investment (FDI) structures and regulatory conditions applicable to pharmaceutical manufacturing, medical device production, and healthcare service provision in Vietnam.
Regulatory Compliance and Business Ethics
- Developing compliance frameworks and risk management policies for pharmaceutical advertising, medical conferences, scientific seminars, and healthcare sponsorship activities;
- Advising on legal issues relating to pharmaceutical and medical device tendering at public and private healthcare facilities;
- Reviewing marketing, distribution, and channel management practices to ensure compliance with healthcare regulations, competition law, and professional ethics standards.
HealthTech and Consumer Health Products
- Advising on regulatory frameworks applicable to telemedicine platforms, digital health applications, and online pharmaceutical distribution models;
- Assisting with quality declaration and product registration procedures for functional foods, dietary supplements, and personal care products;
- Conducting legal risk assessments and advising on business model structuring in an evolving regulatory environment.
Intellectual Property Protection and M&A
- Advising on strategies for the protection of pharmaceutical patents and trademarks, and implementing anti-counterfeiting and anti-infringement measures in the healthcare sector;
- Conducting specialized legal due diligence for M&A transactions and strategic investments in pharmaceutical companies, manufacturing facilities, and private healthcare providers;
- Advising on transaction structures to safeguard intellectual property rights, regulatory licenses, and the commercial value of healthcare projects.
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How can we help?
Contact our team to discuss your legal needs in Vietnam.