Best FDA Law Lawyers in Vietnam

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THE LAM LAW LLC

THE LAM LAW LLC

15 minutes Free Consultation
Vũng Tàu, Vietnam

Founded in 2019
15 people in their team
English
Vietnamese
About THE LAM LAW LLCWho We AreTHE LAM LAW LLC is a Vietnam-based boutique law firm founded by a team of seasoned legal professionals, arbitrators, and legal educators. We specialize in delivering tailored, business-minded legal solutions with international standards and local expertise.Our...
ADK VIETNAM LAWYERS LAW FIRM
Ho Chi Minh City, Vietnam

Founded in 2021
25 people in their team
English
Vietnamese
Welcome to ADK Vietnam Lawyers: A Beacon of Legal Excellence in Ho Chi Minh CityOur Expertise and Clientele ADK Vietnam Lawyers, located in the bustling heart of Ho Chi Minh City, is renowned for its legal expertise and dedication to serving a diverse range of clients. Our practice areas...
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Law Plus
Ho Chi Minh City, Vietnam

Founded in 2000
50 people in their team
Vietnamese
English
Located in Ho Chi Minh City, Vietnam, LawPlus understands the challenges foreigners face when starting and doing business in Vietnam. Our goal is to alleviate those difficulties and ensure a smooth experience by handling all legal complexities on your behalf. Focus on growing your business, let...
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Founded in 2009
30 people in their team
English
Japanese
Vietnamese
Dong Du International Accounting, Taxes & Legal Consulting Group HCMC, Vietnam, Southeast Asia Business Consulting Network, we specialize in accounting services, corporate tax advice, legal advice, business training, human resource consulting, product & market surveys…over 15 years up to...
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Công ty Luật Mina
Hanoi, Vietnam

English
Công ty Luật Mina, a leading law firm in Vietnam, offers comprehensive legal services across various practice areas, including civil law, criminal law, family law, labor law, corporate law, and tax law. The firm is renowned for its team of seasoned attorneys and legal experts, many of whom...
ENT Law LLC
Hanoi, Vietnam

Founded in 2015
10 people in their team
English
Vietnamese
Established since 2015, ENT Law is proud to be a young and vibrant boutique law firm in the legal market of Vietnam. Combining the knowledge and experiences of the founding partners and the vigour and innovative thinking of our lawyers, we strive to deliver the best legal services to clients at the...
Dragon Law Firm
Hanoi, Vietnam

Founded in 2000
50 people in their team
Vietnamese
English
DRAGON LAW FIRMLaw Firm - Prestigious Lawyer Service in HanoiHeadquarter in Hanoi: Room 6, 14th floor, Vimeco Building, Lot E9 Pham Hung Street, Cau Giay District, Hanoi.Office in Long Bien: No. 24, Lane 29, Tram Street, Long Bien Ward, Long Bien District, HanoiLawyer in Hai Phong: No. 102, Lot 14...
Lexcomm Vietnam LLC
Ho Chi Minh City, Vietnam

Founded in 2016
50 people in their team
Vietnamese
English
Lexcomm Vietnam LLC is a dynamic full-service Vietnamese law firm with a seasoned team of highly talented, technically skilled lawyers spread across Hanoi and HCMC to assist clients with complex and sophisticated domestic and international projects and transactions.We have tremendous practical...
Allen & Overy Legal
Hanoi, Vietnam

Founded in 1930
50 people in their team
Vietnamese
English
About usAllen & Overy is a global law firm that helps the world’s leading businesses to grow, innovate and thrive. For almost a century, we have built a reputation for our commitment to think ahead and bring original solutions to our clients’ most complex legal and commercial challenges.At...
Anvi Law Firm
Hanoi, Vietnam

Founded in 2000
50 people in their team
Vietnamese
English
ANVI is a professional law firm in the field of business law, specializing in providing leading legal services to the business community and businesses in the Vietnamese market..MISSIONANVI’s mission is to offer its deep and comprehensive understanding of business law along with extensive...
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About FDA Law in Vietnam

FDA Law in Vietnam refers to the regulations and legal requirements related to the import, manufacture, distribution, and sale of food, drugs, cosmetics, and medical devices. While Vietnam does not have a single "FDA" authority identical to the United States, its Ministry of Health and related agencies play similar regulatory roles. These agencies set the standards for safety, quality, and efficacy to protect public health. Legal compliance in FDA-related matters is essential to operate lawfully within Vietnam’s fast-growing and regulated marketplace.

Why You May Need a Lawyer

Navigating FDA Law in Vietnam can be complex, especially for foreign companies or individuals unfamiliar with local regulations. You may need legal assistance for the following reasons:

  • Registering drugs, medical devices, food, or cosmetics with the relevant authority
  • Ensuring product labeling and advertising meet Vietnamese requirements
  • Addressing product recalls or enforcement actions
  • Dealing with import and export compliance
  • Resolving disputes with regulators, partners, or customers
  • Structuring business operations to meet all compliance obligations
  • Managing intellectual property issues related to FDA-regulated products
  • Handling administrative sanctions, fines, or seizure of goods
  • Facilitating mergers, acquisitions, or joint ventures in regulated sectors
  • Staying up to date with new and evolving Vietnamese FDA regulations

Local Laws Overview

Vietnam's FDA-related regulations are largely governed by the Law on Food Safety, Law on Pharmacy, Law on Medical Examination and Treatment, and related decrees, circulars, and agency guidance. Key regulatory bodies include the Ministry of Health, its Drug Administration, and the Vietnam Food Administration.

Important aspects include:

  • Registration and licensing for products such as pharmaceuticals, medical devices, food, and dietary supplements
  • Mandatory compliance with labeling and advertising standards to ensure accuracy and prevent misleading the public
  • Clear rules for manufacturing processes, quality assurance, and storage
  • Strict controls for imports and exports, including permits and documentation
  • Ongoing requirements for post-market surveillance, recalls, and reporting adverse events
  • Administrative penalties for violations, ranging from warnings to business license revocation or criminal prosecution
  • Protecting intellectual property, including patents and trademarks for FDA-regulated products

Frequently Asked Questions

What is the equivalent authority to the US FDA in Vietnam?

Vietnam does not have an exact equivalent but the Ministry of Health, along with its specialized departments like Drug Administration of Vietnam and the Vietnam Food Administration, fulfills similar functions related to public health product regulation.

Which products need registration or approval from health authorities?

Drugs, medical devices, food products, dietary supplements, and cosmetics often need to be registered and approved by the appropriate authority before they can be imported, manufactured, or sold in Vietnam.

What are the main laws governing FDA-regulated products in Vietnam?

Key statutes include the Law on Food Safety, the Law on Pharmacy, the Law on Medical Examination and Treatment, and various government decrees and circulars which compliment these main laws.

How can foreign companies register their products in Vietnam?

Foreign companies typically need a local authorized representative or distributor to handle registration. The process involves submitting documentation, product information, samples, and other data to the relevant regulatory body.

What are the labeling requirements for FDA-regulated products?

Labels must be in Vietnamese and include information such as product name, ingredients, use instructions, warnings, manufacturing date, expiry date, and manufacturer details. Special rules apply to certain products, such as pharmaceuticals.

Are there restrictions on advertising drugs or medical devices?

Yes, strict controls apply to advertising drugs and medical devices. All advertising materials must be approved by the Ministry of Health and must not exaggerate benefits or mislead consumers.

What penalties apply for violations of FDA laws in Vietnam?

Penalties range from fines and product recalls to suspension or revocation of business licenses, as well as possible criminal charges for serious violations endangering public health.

How are product recalls handled in Vietnam?

Manufacturers and distributors are required to coordinate with the relevant authorities to remove unsafe or non-compliant products from the market, inform users, and report to the competent agency.

Do dietary supplements face the same regulations as pharmaceuticals?

While dietary supplements are less strictly regulated, they still require registration, safety assessments, and truthful labeling. They cannot be marketed as having medicinal effects unless scientifically substantiated and approved.

How often do FDA regulations change in Vietnam?

Vietnam's regulatory environment for FDA-related products is evolving rapidly. Laws and guidelines are updated regularly to align with international standards and address emerging health concerns.

Additional Resources

For those seeking more information or legal guidance on FDA Law in Vietnam, consider the following resources:

  • Ministry of Health of Vietnam - the main regulatory body for health products
  • Drug Administration of Vietnam - responsible for the regulation of pharmaceuticals
  • Vietnam Food Administration - oversees food safety and hygiene
  • Vietnam Ministry of Science and Technology - involved in standards and intellectual property issues
  • Vietnam Chamber of Commerce and Industry - offers resources for businesses entering regulated sectors
  • Professional legal associations and law firms specializing in pharmaceutical, food, and medical device law

Next Steps

If you need legal assistance in FDA Law in Vietnam, begin by gathering all relevant information and documents about your product or project. Identify the main legal issues or questions you have. Contact a qualified lawyer or legal firm with expertise in health product regulation. During your consultation, ask about their experience with similar FDA Law cases, their familiarity with working with government agencies, and their approach to resolving your specific concerns. Staying proactive and informed will help you navigate Vietnam’s regulatory landscape effectively and ensure compliance while protecting your business interests.

Lawzana helps you find the best lawyers and law firms in Vietnam through a curated and pre-screened list of qualified legal professionals. Our platform offers rankings and detailed profiles of attorneys and law firms, allowing you to compare based on practice areas, including FDA Law, experience, and client feedback. Each profile includes a description of the firm's areas of practice, client reviews, team members and partners, year of establishment, spoken languages, office locations, contact information, social media presence, and any published articles or resources. Most firms on our platform speak English and are experienced in both local and international legal matters. Get a quote from top-rated law firms in Vietnam - quickly, securely, and without unnecessary hassle.

Disclaimer:
The information provided on this page is for general informational purposes only and does not constitute legal advice. While we strive to ensure the accuracy and relevance of the content, legal information may change over time, and interpretations of the law can vary. You should always consult with a qualified legal professional for advice specific to your situation. We disclaim all liability for actions taken or not taken based on the content of this page. If you believe any information is incorrect or outdated, please contact us, and we will review and update it where appropriate.