How to Register Medical Device in Vietnam The Simple Way?

Q: My company is planning to distribute products in Vietnam, what are the regulations that we need to consider?

Prior to distributing your product in Vietnam, you will have to register them at an adequate authority based on the kind of imported products. As only a Vietnamese legal entity can register products, you will need to find either a reliable local distributor or set up a foreign-owned company.

Q: Is it safe to register the product under a local distributor?

Yes and no. It is very important to choose a reliable distributor because he/she will register the product under their company and become the product licence holder as well as the import licence holder. We offer undername import services and thus registering your product under Cekindo. In this case, you do not need to worry about the trustworthiness of this deal. Furthermore, Cekindo does not request the right of exclusivity, so you are allowed to have more sub-distributors.

Q: What are the commonly imported products in Vietnam?

Cekindo’s clients usually request registration of products from the following categories: Cosmetics, Medical devices, Food and beverages such as wine, and Health supplements.

Why Invest in Medical Industry in Vietnam

With a population of more than 95 million and continuous economic growth, standards of Vietnamese people are continually improving, and the demand for health care and medical products is getting higher and higher.

Medical supplies in Vietnam are in a shortage condition, and many hospitals are in need to upgrade their existing instruments. However, local companies are not able to manufacture advanced medical equipment, and the country relies heavily on foreign investors.

In Vietnam, where medical devices and their related products have a profit margin of between 35 and 40 percent, it became a big gold mine to register and distribute medical equipment.

How to Register Medical Devices 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 Department of Medical Equipment and Health Works (DMEHW) under the Ministry of Health (MOH).

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).

The process of medical device registration differs based on the classification they belong to. While Class A medical devices require a declaration of an applicable standard dossier, the Class B-D 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 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 Devices Registration 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 devices registration in Vietnam.

Contact Our Consultant

Please send your question(s) by filling in this form. Our consulting team will quickly answer you via E-mail. Feel free to visit our office to get more details about our services.

Selected Testimonials

Besides being understanding, patient and kind; Cekindo was extremely efficient and practical as well and guided me every step along the way. I would highly, highly recommend anyone who is either in urgent or not-so-urgent need of obtaining a visa for Vietnam to work with Cekindo. It has been a privilege doing business with them and I know who will be my agents in the future!

Gauthier D'haenens

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

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.

Cekindo handled business visa for our new colleague promptly and made the start of our company in Vietnam easier and faster. I particularly enjoyed communication with the consultant, who advised the best solution for us and was all the time available to answer any questions. She made sure that all the documents were collected and prepared on time and we got great support during the whole process. Thank you Cekindo and I hope to cooperate again in the near future!

Ivana Bartonkova
Marketing and HR director of Port Cities Vietnam

Frequently Asked Questions