Medical Device Registration in Vietnam
Our medical device registration consultancy in Vietnam offers complete support, from classification and submission to post-market compliance, ensuring your devices meet Vietnamese regulations.
Why Register Medical Devices in Vietnam?
Market Access and Distribution
Market Access and Distribution
Proper medical device registration in Vietnam ensures smoother market access and distribution across Vietnam, helping you avoid legal issues, delays, and supply chain disruptions. This allows your products to reach healthcare providers efficiently.
Partnering Opportunities
Partnering Opportunities
Vietnam’s expanding healthcare sector attracts local and international investors. By registering your IVD device, you unlock opportunities for strategic partnerships with local distributors, hospitals, and clinics, enhancing your market presence and business growth.
Regulatory Compliance
Regulatory Compliance
Registering your IVD device guarantees compliance with Vietnam’s regulatory requirements, enabling legal marketing and distribution. It demonstrates your commitment to quality and safety, strengthening your brand’s reputation.
Our Medical Device Registration Services
Authorised Representative Services
- Liaison with the local government agency on all regulatory issues, including amendments and change notifications
- Regulatory monitoring to alert you to any changes or new regulations applicable to your product
- Licence holding
- Adverse event reporting and management
- Product alert and recall tracking
- Complaint handling
Who Can Register a Medical Device in Vietnam?
- Vietnamese enterprises, cooperatives, and household businesses that own medical devices.
- Vietnamese enterprises, cooperatives, and household businesses authorised by device owners to register medical devices.
- Representative offices of foreign traders in Vietnam who own or are authorised to register medical devices.
Options for Foreign Manufacturers
Set Up a Legal Subsidiary
- Register with the local Department of Planning and Investment.
- Obtain investment certificates and a business licence.
Appoint a Local Importer or Distributor
- Choose a local partner with a valid Establishment License to register the medical devices.
Appoint an Independent Third Party
- Select a medical device registration consultancy like Andaman Medical, which holds a valid Medical Device Establishment License and can act as your Local Authorised Representative. This option allows you to register and maintain your device licence while appointing multiple importers or wholesalers without affecting the product licence. Andaman Medical can also import medical devices. For more details, refer to their importation of medical devices page.
Who Can Register a Medical Device in Vietnam?
- Vietnamese enterprises, cooperatives, and household businesses that own medical devices.
- Vietnamese enterprises, cooperatives, and household businesses authorised by device owners to register medical devices.
- Representative offices of foreign traders in Vietnam who own or are authorised to register medical devices.
Options for Foreign Manufacturers

Set Up a Legal Subsidiary
- Register with the local Department of Planning and Investment.
- Obtain investment certificates and a business licence.

Appoint a Local Importer or Distributor
- Choose a local partner with a valid Establishment License to register the medical devices.

Appoint an Independent Third Party
- Select a medical device registration consultancy like Andaman Medical, which holds a valid Medical Device Establishment License and can act as your Local Authorised Representative. This option allows you to register and maintain your device licence while appointing multiple importers or wholesalers without affecting the product licence. Andaman Medical can also import medical devices. For more details, refer to their importation of medical devices page.
Classification of Medical Devices in Vietnam
Definition of Medical Devices in Vietnam
- Diagnosis, prevention, monitoring, treatment, or relief of diseases or injuries.
- Checking, replacement, modification, or support of physiological processes or surgery.
- Life support or sustainment.
- Conception control.
- Sterilisation of medical devices, including chemicals used during diagnosis.
- Providing diagnostic, monitoring, and treatment information through specimen examination from the human body.
An “in vitro diagnostic (IVD) medical device” refers to a reagent, calibrator, control material, instrument, apparatus, equipment, or system used alone or in combination to examine specimens taken from the human body.
- Class A: Low Risk
- Class B: Low to Moderate Risk
- Class C: Moderate to High Risk
- Class D: High Risk
- Intended use
- Legal manufacturer
- Classification result
- Single
- Family
- System
- Set
- IVD Test Kit
- IVD Cluster
Registration Process Overview
Step 1: Determine Classification Risk
The classification risk and result of a medical device should be determined by the applicant/licence holder.
Step 2: Class A and B Medical Devices
- Registration applications must be uploaded to the Local Department of Health via the online portal https://dmec.moh.gov.vn.
- Upon approval, a Notification of Applicable Standard will be issued, which has lifetime validity.
Step 3: Class C and D Medical Devices
- Registration applications must be submitted to the Ministry of Health (Department of Infrastructure and Medical Equipment) via the online portal https://dmec.moh.gov.vn.
- Upon approval, a Circulation Registration Certificate (Product Licence) will be issued, which does not have an expiration date. The product licence for classes C and D will be fully implemented from January 1, 2025.
Step 4: Guidelines and Payment
- Applications for medical device product registrations must follow the guidelines under No. 98/2021/ND-CP about Medical Device Management, and its amendment Decrees No. 07/2023/ND-CP and Decree 96/2023/NĐ-CP.
- Once the necessary documentation has been uploaded according to the product’s classification and group, the registrant can process the payment simultaneously.
Step 1: Determine Classification Risk
The classification risk and result of a medical device should be determined by the applicant/licence holder.
Step 2: Class A and B Medical Devices
- Registration applications must be uploaded to the Local Department of Health via the online portal https://dmec.moh.gov.vn.
- Upon approval, a Notification of Applicable Standard will be issued, which has lifetime validity.
Step 3: Class C and D Medical Devices
- Registration applications must be submitted to the Ministry of Health (Department of Infrastructure and Medical Equipment) via the online portal https://dmec.moh.gov.vn.
- Upon approval, a Circulation Registration Certificate (Product Licence) will be issued, which does not have an expiration date. The product licence for classes C and D will be fully implemented from January 1, 2025.
Step 4: Guidelines and Payment
- Applications for medical device product registrations must follow the guidelines under No. 98/2021/ND-CP about Medical Device Management, and its amendment Decrees No. 07/2023/ND-CP and Decree 96/2023/NĐ-CP.
- Once the necessary documentation has been uploaded according to the product’s classification and group, the registrant can process the payment simultaneously.
Required Documents to Register Medical Devices in Vietnam
- Free Sale Certificate
- Letter of Authorisation
- Certificate of Warranty Eligibility
- ISO 13485 Certificate
- Classification Result
- Declaration of Conformity
- Technical Brief
- Instructions for Use (in Vietnamese)
- Labelling
- Catalogue
- CSDT and Appraisal Result of CSDT (required for Class C and D medical devices from 01 Jan 2024)
- Clinical Certificate issued by a competent authority in Vietnam (required for Class C and D medical devices from 01 Jan 2026, except for submission through the fast-track route)
- Sample Approval
- Inspection and Calibration Documentation under the Ministry of Science and Technology’s responsibility.
- Certificate of Quality issued by a competent authority in Vietnam.
Typical Fees and Timeline
Class | Fee | Timeline |
---|---|---|
Class A | 1,000,000 VND (~44 USD) | 15-30 working days |
Class B | 3,000,000 VND (~132 USD) | 15-30 working days |
Class C and Class D | 6,000,000 VND (~264 USD) | 12-24 months |
Temporary Discount (from 1 July 2024 to 31 December 2024):
- Class A: 700,000 VND (30% discount from 1,000,000 VND)
- Class B: 2,100,000 VND (30% discount from 3,000,000 VND)
- Class C and D: 4,200,000 VND (30% discount from 6,000,000 VND)