Medical Device Registration in Vietnam
Overview
Medical device registration in Vietnam is a mandatory regulatory process for manufacturers, distributors, and brand owners intending to market medical devices, medical equipment, or in-vitro diagnostic (IVD) products in the Vietnamese market. Vietnam classifies medical devices based on risk levels, and each classification requires a specific regulatory pathway, documentation set, and compliance approach.
The medical device registration in Vietnam process involves product classification, dossier preparation, technical documentation review, and submission through the designated regulatory system. Business Hub Asia supports clients by providing structured guidance throughout the product registration process.
Free ConsultationKey Features
Device Classification Review
Assessment of medical equipment and IVD registration risk category.
Regulatory Strategy Advisory
Guidance on the appropriate registration pathway
Dossier Preparation Support
Structured review of technical and administrative documents.
Submission Coordination
Alignment with procedural requirements for product registration in Vietnam.
Post-Registration Support
Assistance with updates, variations, and lifecycle compliance.
Minimum Requirements
Company Information
Manufacturer or distributor legal documents.
Product Information
Device description, intended use, and specifications.
Technical Documentation
Safety, performance, and quality system records.
Classification Evidence
Risk-based categorization justification.
Authorization Documents
Letters of authorization or representation, if applicable.
Process and Timeline
1
Initial Regulatory Assessment
Evaluation of product type and regulatory pathway.
2
Medical Device Classification
Determination of applicable medical device risk class.
3
Documentation Preparation
Compilation of technical and administrative files.
4
Registration Submission
Filing through the applicable regulatory platform.
5
Monitoring & Follow-Up
Ongoing coordination during review and approval stages.
Important Consideration
- Medical devices in Vietnam are regulated based on risk classification.
- IVD registration follows additional technical assessment criteria.
- Local regulatory alignment is required for foreign manufacturers.
- Changes to product specifications may require post-registration updates.
- Compliance obligations continue after registration approval.
Frequently Asked Questions
Can foreign manufacturers register medical devices directly?
Foreign companies typically require local regulatory representation.
How are medical devices classified in Vietnam?
Devices are classified based on risk level, influencing registration requirements.
Is IVD registration different from other medical devices?
Yes. IVD registration involves specific technical and clinical documentation.
Can one registration cover multiple product models?
Only if the models share similar technical and regulatory characteristics.
Are post-registration obligations required?
Yes. Ongoing compliance and reporting may apply throughout the product lifecycle.
Your Trusted Partner in Vietnam Healthcare Compliance
Expert guidance through the Ministry of Health’s registration process for international and local providers.
Disclaimer
The content provided on this website is published by PT. Bisnis Hub Asia (“we“, or “us“) for general informational purposes only. While every effort is made to ensure the accuracy and timeliness of the information presented, we make no representations or warranties, express or implied, as to the completeness, accuracy, reliability, suitability, or availability of any content, products, or services described on this website. Any reliance placed on such information is strictly at the user’s own risk.
We are a private, independent entity and are not affiliated with, authorized by, or acting on behalf of the Government of the Republic of Indonesia, its ministries, agencies, or any officially appointed representatives. This website does not provide, offer, or promote any official government documents or services, including but not limited to:
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By accessing and using this website, you acknowledge and agree to the terms set out in this Disclaimer. You further agree to use this website and the information provided responsibly and in compliance with applicable laws and regulations.
For further information or questions regarding this Disclaimer, please contact us via the channels provided on our Contact page.
Disclaimer
The content provided on this website is published by PT. Bisnis Hub Asia (“we“, or “us“) for general informational purposes only. While every effort is made to ensure the accuracy and timeliness of the information presented, we make no representations or warranties, express or implied, as to the completeness, accuracy, reliability, suitability, or availability of any content, products, or services described on this website. Any reliance placed on such information is strictly at the user’s own risk.
We are a private, independent entity and are not affiliated with, authorized by, or acting on behalf of the Government of the Republic of Indonesia, its ministries, agencies, or any officially appointed representatives. This website does not provide, offer, or promote any official government documents or services, including but not limited to:
-
Business identification numbers (Nomor Induk Berusaha – NIB);
-
Tax refunds or rebates;
-
Visas or electronic travel authorizations (e-Visa, e-VoA);
-
Passports or other immigration-related documents.
Any references to such services are provided solely for general informational purposes and should not be construed as an offer or facilitation of official services.
We are committed to ensuring the protection of your personal data in accordance with Law No. 27 of 2022 on Personal Data Protection. Any personal information collected through this website will be processed for the purposes clearly stated in our [Privacy Statement]. We do not sell or misuse personal data under any circumstances.
By accessing and using this website, you acknowledge and agree to the terms set out in this Disclaimer. You further agree to use this website and the information provided responsibly and in compliance with applicable laws and regulations.
For further information or questions regarding this Disclaimer, please contact us via the channels provided on our Contact page.
Meet the Expert
Meet the Expert
Tjhia Edy Tarlesno, SH, LLM.
Chief Operating Officer at Business Hub AsiaWith over 20 years of experience across Southeast Asia, Edy serves as the Legal & Compliance Director at Business Hub Asia, guiding businesses through complex regulatory frameworks and market entry. A former leader at global consulting firms and a frequent industry speaker, he specializes in corporate law, compliance, insolvency, and foreign investment structuring to help clients manage risk and grow with confidence.
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