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.

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

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 Registration in Vietnam with Cekindo

Cekindo provides one-stop market entry services in South East Asia. Our experienced team of lawyers and business consultants is not only able to register your medical devices products in Vietnam, but also establish a Representative Office (RO) needed for foreign traders.
Contact us today and get a free quotation on medical device registration in Vietnam.

Contact Our Consultants

Please send your question(s) by filling in this form. Our consulting team will quickly answer you via Email for a free consultation. Due to the current situation we are able to provide our services 100% online for everyone safety

Selected Testimonials

ryker-logo Cekindo has been a great help in the incorporation of our company in Vietnam by providing useful information and clear explanation on complicated regulatory procedures. The team went the extra mile by helping us to clarify on other matters pertaining to Vietnam, and proactively helped us to liaise with the respective internal functions on our queries and responded promptly.
Louis Koh Kay Boon
CEO, Ryker Company Limited
finchef-testimonial Cekindo helped us to cover important quarterly reporting when our Chief Accountant suddenly resigned. They did all the necessary paperwork. Fast and reliable.
Jozef M.
CEO of Finchef Co., Ltd.
Herewith we want to express our appreciation to PT. Cekindo Bisnis Grup and their team for all the support on medical devices services so far. We would like to take this opportunity to thank Cekindo for taking the time to listen to our needs. Whenever a need has arisen, we have always received their consistent, timely and quality support. We would not hesitate to recommend Cekindo team for any related activity or services.
My Linh Hoangova
Executive, ELC Group
CFLD_Max-Yang After comparing several consultants, I found Cekindo is a international and professional organization with good understanding of local market. Cekindo helped our company to set up our first Indonesian entity, and also helps with day-to-day operation.  Cekindo showed high level of professionalism. Jump start the business in Indonesia, take care of routine process, therefore we can focus more on our core business.
Max Yang
President, Indonesian Region, China Fortune Land Development Co., Ltd.

Selected Clients

Frequently Asked Questions

Do all medical devices need to be registered before they are permitted to be distributed and sold in the territory of Vietnam?

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.

What is the general registration process of Class A medical devices?

How about the registration process for Class B to D medical devices?

How long will the license last for Vietnam medical device registration of each category?

Do I have to submit approval from my country of origin for Vietnam medical device registration?

Is local testing required for Vietnam medical device registration?

What about clinical trials? Are they necessary?

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