andaman medical opens a second office in vietnam

Andaman Medical opens a second office in Vietnam

We’re delighted to announce that we are opening a second office in Vietnam. The new office in Hanoi will commence operations shortly, while our Vietnam operations continue to grow from our office in Ho Chi Minh City

Vietnam is a growing market for medical devices; forecasted to be worth US$1.8 Billion by 2022, with a compound annual growth rate (CAGR) of 9.6% between 2017 and 2022F*.

In terms of domestic consumption of medical devices, Vietnam currently imports more than 90% of its needs in medical devices as there are few local manufacturers of sophisticated or specialized devices with most imports coming from Japan, Germany, the USA, China and Singapore.

Imports of medical equipment in 2017 totalled US$1.1 billion which comprised mainly diagnostic imaging equipment (X-ray, ultrasound, magnetic resonance imaging, computed tomography scanners) and equipment used for surgery, endoscopy, sterilization, testing and medical waste treatment, according to the Ho Chi Minh City Medical Equipment Association.

What’s more, Vietnam is experiencing much regulatory change as the country aims to harmonize with the ASEAN Medical Device Directive, which means that being able to rely on local, on-the-ground regulatory experts is key to accessing the Vietnamese market. 

And with a population of 97.3 million in 2020, demand will only grow for medical devices. Especially considering that people aged 65 and over in 2020 constituted around 7.9% of the population; which means that Vietnam has one of the fastest ageing populations in Asia as it expected that almost a third of the population will be 60 or over by 2050 approximately 29 million people according to Help Age International. 

Registering medical devices in Vietnam

Only companies registered locally in Vietnam and who have a valid Establishment License from the Department of Planning and Investment may register a medical device. These organizations must declare applicable standards or register the circulation of medical devices in Vietnam. 

The Ministry of Health in Vietnam requires foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorised Representative (LAR), sometimes referred to as the in-country representative or marketing authorization holder.

Andaman Medical has been a local authorized representative in Vietnam since 2017. As your marketing authorization holder or local authorized representative in Vietnam we will represent your company in all dealings with the Ministry of Health responsible for medical devices and in-vitro diagnostics including:

We will also:

  • facilitate the importation process including customs clearance
  • maintain communication with appointed distributors
  • ensure that the appropriate conformity tests have been carried out, if required
  • ensure that the medical device or IVD is correctly labelled and that information is provided in Vietnamese
  • accept all calls from the Ministry of Health regarding the foreign manufacturer and its products and liaising accordingly with the foreign manufacturer including scheduling inspection(s) of the manufacturer’s facilities, if required
  • maintain our office including a telephone and email connection in Vietnam
  • monitor regulations to alert you to any changes or new regulations applicable to your product.

Click here for more information about registering your device in Vietnam.

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