Sliders – LAR VN

Appointing a LAR gives foreign companies a local presence and in-depth knowledge of the Vietnamese regulatory landscape without the need to set up their own subsidiary. This provides practical business advantages and simplifies operations.

The LAR ensures ongoing compliance with Vietnamese regulations by:

• Obtaining all necessary permits and licences.
• Meeting reporting and documentation requirements.
• Adhering to local laws and medical device regulations, including post-market surveillance and trade eligibility for devices.

To handle the registration of medical devices, the LAR must:

• Create accounts on the DMEC and VSNW websites for medical device and in-vitro diagnostic registration with the Ministry of Health.
• Apply for eligibility to trade Classes B, C, and D medical devices and obtain the Certificate of Medical Device Trading for those classes.

The LAR is responsible for filing applications and managing business registrations with Vietnamese authorities. This includes:

• Obtaining necessary licences such as the Establishment License and Investment License.
• Setting up representative offices or branches as needed.

The LAR acts as the primary point of contact between the foreign company and Vietnamese regulatory bodies, including the Ministry of Health (MOH). They handle all official communications, submissions, and negotiations on behalf of the foreign entity.

Foreign companies without a registered office in Vietnam are legally required to appoint a Local Authorised Representative (LAR). This is mandated by Vietnamese law to ensure compliance and the ability to conduct business activities within the country.