Medical Device Registration in Vietnam

Vietnam’s dynamic healthcare sector is full of potential—but navigating its regulatory landscape can be complex and time-consuming. That’s where Andaman Medical comes in.

With our trusted expertise in medical device registration in Vietnam, we make the process clearer and more manageable. From understanding local requirements to ensuring full compliance, we help you overcome regulatory hurdles and achieve faster market access. Whether you’re a start-up manufacturer or a global medical device company, we handle the complexities, so you can focus on delivering quality medical technologies to patients and healthcare providers across Vietnam.

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Medical Device Registration in Vietnam

The In Vitro Diagnostics (IVD) market in Vietnam is growing rapidly, driven by demand for early disease detection and advancements in healthcare. The Department of Medical Equipment and Construction (DMEC) regulates IVD device registration to ensure safety and quality.

Our medical device registration consultancy in Vietnam offers complete support, from classification and submission to post-market compliance, ensuring your devices meet Vietnamese regulations.

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Why Register Medical Devices in Vietnam?

Registering your IVD or medical device in Vietnam is more than just meeting regulatory requirements—it’s about tapping into one of Southeast Asia’s fastest-growing and most dynamic healthcare markets.

At Andaman Medical, we provide comprehensive regulatory support to help you navigate Vietnam’s evolving approval process with ease. From ensuring a seamless registration experience to maintaining ongoing compliance, we’re your trusted partner every step of the way.

Here’s why Vietnam is a key destination for your medical device registration:

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 and non-IVD medical 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 and non-IVD medical 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.

Why Choose Andaman Medical as Your Medical Device Registration Consultant in Vietnam?

What You Need to Know About Medical Device Registration in Vietnam?

To register a medical device in Vietnam, you must be a locally registered company with a valid Establishment Licence from the Local Department of Planning and Investment. The eligible organisations include:

  • 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

Since only local companies can obtain an Establishment License, foreign manufacturers have three options to register their medical devices in Vietnam:
1

Set Up a Legal Subsidiary

  • Register with the local Department of Planning and Investment.
  • Obtain investment certificates and a business licence.

2

Appoint a Local Importer or Distributor

  • Choose a local partner with a valid Establishment License to register the medical devices.

3

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?

To register a medical device in Vietnam, you must be a locally registered company with a valid Establishment Licence from the Local Department of Planning and Investment. The eligible organisations include:

  • 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

Since only local companies can obtain an Establishment License, foreign manufacturers have three options to register their medical devices in Vietnam:

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

A “medical device” in Vietnam refers to any instrument, implant, apparatus, material, in-vitro reagent, calibrator, or software that meets the following criteria and is used for purposes such as:

  • 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.
These devices must not rely on pharmacological, immune, or metabolic mechanisms to achieve their primary function, although such mechanisms may assist.

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.
Medical devices in Vietnam are classified by risk according to the ASEAN Medical Device Directive (AMDD) into four classes:
  • Class A: Low Risk
  • Class B: Low to Moderate Risk
  • Class C: Moderate to High Risk
  • Class D: High Risk
Medical devices and IVDs can be grouped together for a single registration certificate based on the following criteria:

  • Intended use
  • Legal manufacturer
  • Classification result
The grouping categories include:

  • Single
  • Family
  • System
  • Set
  • IVD Test Kit
  • IVD Cluster

Registration Process Overview

Here’s a step-by-step overview to guide you through the IVD registration process in Vietnam:

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

Medical device registration in Vietnam requires both legal and technical documents. Below is a list of the necessary documentation
  • 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.
  • Testing Certificate

Typical Fees and Timeline

Registering medical devices in Vietnam involves specific fees and timelines. Below is an overview of the typical fees and expected timelines for the registration process:
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):

To support businesses, the Vietnam Ministry of Finance issued Circular No. 43/2024/TT-BTC, effective from 1 July 2024 to 31 December 2024, offering a 30% discount on evaluation fees. As of 1 January 2025, the standard fees will apply again.

  • 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)

Navigating medical device registration in Vietnam can be complex, but Andaman Medical is here to simplify the process and ensure you stay fully compliant. Connect with our experts today and take the first step toward smooth registration!

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