Pharmaceutical Marketing Authorisation (MA) Registration in Vietnam
Navigating Vietnam's complex regulatory landscape with precision, expertise, and unwavering commitment to your success in the healthcare sector.
10+
Years Experience
200+
Products Registered
50+
International Clients
Who We Are
How we deal with Vietnam pharmaceutical regulation
BIONMAS offers top-tier pharmaceutical registration services, leveraging extensive local expertise and deep understanding of Vietnam's regulatory landscape. Our skilled team ensures full compliance with local requirements, enabling seamless market entry.
Pharmaceutical Grade Excellence
We combine deep regulatory knowledge with a commitment to quality that meets international pharmaceutical standards.
From pre-registration consultation to full marketing authorization, we guide you through every step with transparency and expertise.
Our Expertise
Our Main Consultation Practices
01
Medicines
Pre-registration consultation
New drug registration, renewal, variation, GMP announcement at HA Vietnam
Monitoring drug status at HA Vietnam, consulting customers, providing solutions
Monitoring regulations, updating customers
02
Cosmetics
Pre-registration consultation
Submission to HA Vietnam
Monitoring status at HA Vietnam, consulting customers, providing solutions
Monitoring regulations, updating customers
03
Medical Devices
Pre-registration consultation
Submission to HA Vietnam
Monitoring status at HA Vietnam, consulting customers, providing solutions
Monitoring regulations, updating customers
What We Offer
Our Services
Marketing Authorization Licenses — we foresee problems, give solutions, and take decisive action on your behalf.
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Foresee the Problem
Proactive identification of regulatory hurdles before they become costly delays.
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Give Solution
Tailored regulatory strategies and corrective action plans for every compliance gap.
⚡
Take Action
Rapid execution with real-time tracking throughout the entire registration process.
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Local Representative
We act as your official representative, liaising with Vietnamese authorities directly.
Why Choose Us
Reason to choose our firm
01
Confidentiality
Strict confidentiality of all dossier information and customer data, protected at every stage.
02
Deep Expertise
Highly qualified experts with years of experience and in-depth knowledge of Vietnam's regulatory framework.
03
Local Representative
Your official representative in Vietnam, connecting with local pharmaceutical distributors and health authorities.
Latest Insights
News & Updates
📋
Regulation Update
New DAV Requirements for Drug Dossier Submission 2025
Vietnam's Drug Administration has released updated guidelines for pharmaceutical dossier preparation and submission timelines...
15 May 2025
🧬
Market Entry
Understanding Vietnam's GMP Certification Process for Foreign Manufacturers
A comprehensive guide to GMP certification requirements for pharmaceutical manufacturers seeking to enter the Vietnamese market...
2 Apr 2025
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Medical Devices
Medical Device Registration: Class II vs Class III Requirements in Vietnam
Breaking down the differences in registration pathways for medical devices across risk classifications under Vietnam's Decree 98...
End-to-end regulatory support for medicines, cosmetics, and medical devices entering the Vietnamese market.
MA Licenses
Marketing Authorization Licenses
🔍
Foresee the Problem
Proactive identification of potential regulatory hurdles before they become costly delays.
💡
Give Solution
Tailored regulatory strategies and corrective action plans to address compliance gaps.
⚡
Take Action
Rapid execution with real-time tracking and updates throughout registration.
🧬
Drug Registration
New registration, renewal, variation, and GMP announcement at DAV Vietnam.
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Cosmetics Registration
Full cosmetic notification and registration submission with ongoing monitoring.
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Medical Devices
Classification, conformity assessment, and registration across all risk categories.
Our Process
How We Work
01
Initial Consultation
We assess your product portfolio and regulatory needs to build a customized registration roadmap.
02
Dossier Preparation
Our experts prepare and review all technical documentation according to Vietnam HA requirements.
03
Submission & Monitoring
We handle all submissions and maintain constant communication with authorities, with real-time updates.
Our Story
Bridging International Pharma with Vietnam's Market
BIONMAS Pharmaceutical Co., Ltd was established to be the trusted bridge between international pharmaceutical companies and Vietnam's dynamic healthcare market.
Our Values
What Drives Us
🔒
Confidentiality First
We treat every client's dossier and business information with the highest level of discretion and legal protection.
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Precision & Accuracy
Pharmaceutical regulation demands perfection. We review every document, every detail with meticulous care.
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Partnership Mindset
We don't just process registrations — we become your long-term regulatory partner in Vietnam.
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Continuous Updates
Vietnam's regulatory environment evolves rapidly. We proactively update our clients on every change.
Our People
Expert Team
👩🔬
Dr. Nguyen Thi Lan
Head of Regulatory Affairs
15+ years of experience in pharmaceutical registration at DAV. Deep expertise in drug dossier preparation and GMP compliance.
👨💼
Mr. Tran Minh Duc
Senior Regulatory Consultant
Specialist in medical devices and cosmetics regulation. Extensive network with Vietnam's health authorities and distributors.
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Dr. Le Thu Huong
Scientific Affairs Manager
Pharmacist with international training in regulatory science, bridging technical documentation with global standards.
Insights & Updates
News & Regulatory Updates
Stay informed on the latest changes in Vietnam's pharmaceutical regulatory landscape.
📋
Regulation Update
New DAV Requirements for Drug Dossier Submission 2025
Vietnam's Drug Administration has released updated guidelines for pharmaceutical dossier preparation and submission timelines. Key changes include new CTD format requirements and stricter bioequivalence data standards for generic drugs.
15 May 2025
🧬
Market Entry
Understanding Vietnam's GMP Certification for Foreign Manufacturers
A comprehensive guide to GMP certification requirements for pharmaceutical manufacturers seeking to enter the Vietnamese market. We cover WHO-GMP, PIC/S GMP and how DAV evaluates foreign facility inspections.
2 Apr 2025
💊
Medical Devices
Class II vs Class III Medical Device Requirements in Vietnam
Breaking down the differences in registration pathways for medical devices across risk classifications under Decree 98/2021/ND-CP and the latest Ministry of Health circulars for 2025.
18 Mar 2025
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Cosmetics
ASEAN Cosmetics Directive: What It Means for Vietnam Registration
How the ASEAN Cosmetics Directive (ACD) aligns with Vietnam's Ministry of Health requirements, and the key steps to submit a compliant Product Notification File (PNF) to the authorities.
5 Feb 2025
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Industry Insight
Vietnam Pharma Market Outlook 2025: Opportunities for International Companies
Vietnam's pharmaceutical market is projected to reach $16.1 billion by 2026. We analyze the key growth segments and regulatory pathways that offer the best opportunities for international manufacturers.
20 Jan 2025
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Legal Update
Pharmaceutical Law Amendments 2024: Impact on Registration Timelines
An analysis of the key amendments to Vietnam's Pharmaceutical Law and how they affect the expected timelines and documentation requirements for new drug applications and renewals in 2025.
8 Jan 2025
Reach Us
Contact Us
Ready to navigate Vietnam's pharmaceutical regulatory landscape? Our team is here to help at every step.
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Address
06/C4, alley 10, Ngo Quyen street, Quang Trung ward, Ha Dong, Hanoi, 100000, Vietnam
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Phone / WhatsApp / Zalo
+84-356 460 628
✉️
Email
bionmas@bionmas.com
🌐
Website
www.bionmas.com
Office Hours
Monday to Friday
9:00 am — 6:00 pm
BIONMAS PHARMACEUTICAL Co., LTD
Tax code: 0110761790
Hosting: Mắt Bão · Domain: bionmas.com
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Send Us a Message
✅
Message Sent!
Thank you. Our team will respond within 1 business day.
Client Portal
Welcome back, Client
Your regulatory cases & account overview
Active Cases
3
Registrations in progress
Completed
7
Successfully registered products
Next Review
15 Jun
Scheduled consultation
Active Registration Cases
Amoxicillin 500mg Capsules
Drug Registration — New Application
Submitted 12 Apr 2025
In Progress
CosmetiClear Serum Line
Cosmetics — Notification
Submitted 28 Mar 2025
Under Review
MedPulse Monitor Pro
Medical Device — Class II
Submitted 5 Feb 2025
Approved ✓
Dashboard Overview
Welcome back, Admin
Total Clients
48
↑ 3 this month
Active Cases
23
↑ 5 this week
Completed
184
↑ 12 this month
Blog Posts
6
2 drafts pending
Recent Cases
Product
Client
Type
Submitted
Status
Action
Amoxicillin 500mg
PharmaCorp Ltd
Drug — New
12 Apr 2025
In Progress
CosmetiClear Serum
BeautyVN Co.
Cosmetics
28 Mar 2025
Under Review
MedPulse Monitor
MedTech Asia
Device Class II
5 Feb 2025
Approved
Vitamin D3 Soft Gels
NutriHealth Inc
Drug — Renewal
1 Jan 2025
Under Review
Recent Clients
Name
Company
Email
Cases
Joined
John Smith
PharmaCorp Ltd
john@pharmacorp.com
3
Jan 2025
Nguyen Thi Mai
BeautyVN Co.
mai@beautyvn.com
1
Feb 2025
David Chen
MedTech Asia
david@medtech.asia
2
Mar 2025
Client Management
Name
Company
Email
Phone
Active Cases
Status
Actions
John Smith
PharmaCorp Ltd
john@pharmacorp.com
+44 20 1234 5678
3
Active
Nguyen Thi Mai
BeautyVN Co.
mai@beautyvn.com
+84 912 345 678
1
Active
David Chen
MedTech Asia
david@medtech.asia
+65 9123 4567
2
Active
Sarah Johnson
NutriHealth Inc
sarah@nutrihealth.com
+1 555 234 5678
1
Pending
Registration Cases
Product
Client
Type
Submitted
Est. Completion
Status
Actions
Amoxicillin 500mg Capsules
PharmaCorp Ltd
Drug — New
12 Apr 2025
Dec 2025
In Progress
CosmetiClear Serum Line
BeautyVN Co.
Cosmetics
28 Mar 2025
Jul 2025
Under Review
MedPulse Monitor Pro
MedTech Asia
Device Class II
5 Feb 2025
✓ May 2025
Approved
Vitamin D3 Soft Gels
NutriHealth Inc
Drug — Renewal
1 Jan 2025
Sep 2025
Under Review
Send Notifications
Compose Message
Sent History
Date
Recipients
Subject
Status
10 May 2025
All Clients
DAV New Regulation Update — May 2025
Delivered
2 Apr 2025
PharmaCorp Ltd
Your case update: Amoxicillin submitted
Delivered
15 Mar 2025
MedTech Asia
MedPulse approval confirmation
Delivered
Blog Posts
Title
Category
Date
Status
Actions
New DAV Requirements for Drug Dossier Submission 2025
Regulation Update
15 May 2025
Published
Understanding Vietnam's GMP Certification for Foreign Manufacturers
Market Entry
2 Apr 2025
Published
Class II vs Class III Medical Device Requirements in Vietnam
Medical Devices
18 Mar 2025
Published
Vietnam Pharma Market Outlook 2025
Industry Insight
—
Draft
Services Management
Service Name
Category
Status
Actions
Drug Registration — New Application
Medicines
Active
Drug Registration — Renewal
Medicines
Active
Cosmetics Notification Submission
Cosmetics
Active
Medical Device Class I Registration
Medical Devices
Active
Medical Device Class II Registration
Medical Devices
Active
Pre-registration Consultation
Consultation
Active
GMP Announcement at HA Vietnam
Medicines
Active
BIONMAS PHARMA.,
Client Portal
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BIONMAS PHARMA.,
Admin Portal
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