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*.
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.
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:
- registering your product
- importing your product as Andaman Medical is also an Import License Holder
- submitting change notifications
- ensuring post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Events.
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.