Medical Devices Registration in Vietnam

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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 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 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

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
Vietnam-import-export-company-logo

It was our pleasure to deal with Cekindo. Indeed, the company with its specialised team was at the highest level of professionalism in dealing with customers and was serious in providing assistance and advice. Many thanks to Cekindo and all the team members. I wish you lasting success in the years to come.

Amer
CEO, Vietnam Family Import Export Company Limited
Shewutrade logo

Cekindo has assisted our company with company registration and nominee director services. Everything has gone smoothly and we wish to have further support in the future. Thank you Cekindo.

Sophie
Founder, Shewutrade Group
Adgorithmics logo

Cekindo Vietnam’s team has always been very responsive and helped us with sense of urgency. We have never been disappointed with Cekindo’s services.

Yasuhiro
Founder, Adgorithmics
cekindo-testimonials

I have successfully received the TRC permit for me and my family, thanks to Cekindo team’s dedication and perseverance. We had some bumps along the way but we got it done, good job. I worked with different consulting companies in the past, outside of Vietnam, Cekindo is one of the most responsive and agile.

Nadav Sarel
Founder & CEO, Telestar Limited Liability Company

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?

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 medical devices of each category?

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

Is local testing required for medical device registration in Vietnam?

What about clinical trials? Are they necessary?

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