How to Register Medical Devices in Vietnam

Vietnam has one of the fastest-growing economies in Asia and the medical equipment industry in Vietnam is presently worth roughly US$1.3 billion. This is expected to continue to grow, well into the future. However, registering devices in a developing economy with changing regulations is not easy. With Cekindo at your side at every step of the way will clarify and facilitate the entire process.

Benefits of Medical Device Registration with Cekindo

  • Professional & Bilingual Legal Experts

    Our team of highly qualified experts have years of experience & speak English in order to assist you every step of the way.

  • Fully Online Process

    Whether you are in Vietnam, or not, we can start the process of medical device registration right away. We can complete all your registration requests fully online.

  • Demystify the Product Registration Process

    We know that doing business in an emerging market like Vietnam provides a large number of challenges. Let us take the headache out of the process.

Medical Device Registration Vietnam

Vietnamese Healthcare Landscape - What you need to know

With a population of more than 95 million and continuous economic growth, the standards of Vietnamese people are continually evolving, and the demand for health care and medical products does not always meet the current supply. Local companies are not able to manufacture advanced medical equipment, therefore the country relies heavily on foreign imported medical products.

In Vietnam, where medical devices and their related products have a profit margin of between 35 and 40 percent, the investment opportunities for foreign medical companies are hot.

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Medical Device Registration Process in Vietnam

Register Medical Device in Vietnam

How to a Register Medical Device in Vietnam

All medical devices that enter the Vietnamese market must be registered prior to their distribution in Vietnam. The registration is governed and approved by the Health Service Department for class A devices and the Ministry of Health (MOH) for class B, C, and D devices.

Importantly, both domestic and imported medical equipment must obtain a Marketing Authorization (MA) license and other administrative documents such as Good Manufacturing Practice (GMP) or a Certificate of Pharmaceutical Products (CPP). All classes of medical devices require a free sale registration dossier (CFS).

Medical device classification in Vietnam

The classification of medical devices in Vietnam is now based on a risk classification (group A, B, C, and D) as opposed to the former division based on function classes.

  • Class A – lowest risk
  • Class B – low risk
  • Class C – high risk
  • Class D – highest risk

Medical instruments that belong to Class A are considered “lowest risk” such as bandages or surgical gloves while Classes B, C and D include “higher-risk” or “more invasive products” such as artificial hearts or contact lenses.

Medical device classification in Vietnam
government agency medical device registration vietnam

Government Agency Responsible

The Ministry of Health's Department of Medical Equipment and Health Works (DMEHW) is the regulatory organization that oversees the registration and licensing of all medical devices in Vietnam.

This agency acts as a branch of Vietnam's Ministry of Health (MOH) which issued decrees 36 and 39 in 2016, directing that all device registrations be handled by the DMEHW, which operates under the jurisdiction of the MOH.

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Rules & Regulations Regarding the Registration of Medical Devices

Clinical trials are required for medical devices that have never been imported into Vietnam and that provide a new feature or therapy. Foreign clinical studies are normally permitted; however, the DMEHW may seek local clinical trials conducted by the MOH in exceptional circumstances.

Class A Device
Regulations

A declaration of the appropriate standard dossier is required for Class A devices. The following documents are required:

  • The form for applying
  • Declaration of a class A application
  • Table of medical equipment classifications
  • Quality control standards certificate
  • The owner of the medical equipment must sign a letter of authorization.
  • Certificate of eligibility for warranty provision
  • Conformity certificate
  • The device's written instructions
  • Labeling on the device
  • Free Sales Certificate

Class B Device
Regulations

A free sale registration dossier is required for Class B-D devices. The following documents are required:

  • The form for applying
  • Table of classifications
  • Conformity certificate
  • Certificate of eligibility for warranty provision
  • Functions, specs, and other technical details for the device are described in this catalog.
  • The device's written instructions
  • Free Sales Certificate
  • Labeling on the device
  • Medical equipment: a brief description (in Vietnamese)
  • The device's written instructions
  • Any remarks made in a language other than English or Vietnamese must be translated into that language

Class C & D Device
Registration

  • The form for applying
  • Table of classifications
  • Conformity certificate
  • Certificate of eligibility for warranty provision
  • Functions, specs, and other technical details for the device are described in this catalog
  • The device's written instructions
  • Free Sales Certificate
  • Labeling on the device
  • Medical equipment: a brief description (in Vietnamese)
  • The device's written instructions
  • Summary of clinical testing data for devices
  • A certificate of inspection is required for IVDs
  • Any remarks made in a language other than English or Vietnamese must be translated into that language
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FAQs

Yes, they do. Registering all your medical devices in Vietnam is mandatory before they can be sold and distributed in the country. A license named Marketing authorization (MA) license is also required before the sales.

Once the authority has determined a medical device as Class A, a declaration of applicable standards needs to be submitted to the local Department of Health. Upon approval, the local Department of Health will proceed with the receipt note issuance. Then, within three working days, the MOH will announce the details of the registered medical device online.

Once a medical device is determined as Class B, Class C or Class D, the representative should submit an application for a free-sale registration number to the MOH. The MOH will issue a receipt note upon approval, and announce the details of the registered medical device online within 3 working days as well.

For Class A devices, their licenses are valid indefinitely; as for Class B, Class C and Class D devices, their licenses are valid for five years.

Yes, all approval in the country of origin, including CE Mark certificate and U.S. FDA approval, must all be submitted.

No, it is not.

If you have never imported your medical devices into Vietnam, then clinical trials may be requested. Foreign clinical trials may suffice, but each case may differ from another.