Requirements for Organizations Applying for Medical Equipment Registration in Vietnam

Requirements for Organizations Declaring Applicable Standards or Applying for Free Sale Registration of Medical Equipment in Vietnam.

Article 21, Decree 36/2016/NĐ-CP on Medical Equipment Management states:

** The following organizations are allowed to declare applicable standards or to apply for free sale registration of a medical equipment:

- Vietnamese enterprises, cooperatives or business households that are in possession of a medical equipment;

- Vietnamese enterprises, cooperatives or business households trading medical equipment that are authorized by medical equipment's owners and follows the registration procedures;

- Representative offices in Vietnam of foreign traders who are the owners of the medical equipment, or who are authorized by the owners of the medical equipment.

**Any organization declaring the applicable standard or carrying out registration of free sale of medical equipment must have warranty service providers in Vietnam, or sign a contract with an organization capable of providing warranty services on medical equipment, as registered under the owner's name.  Exception to this are disposable medical equipment.

If the organization declaring the applicable standard or conducting the registration for free sale of medical equipment is included in Clause 1-C of this Article (Representative Offices of Foreign Traders in Vietnam), the owners of the medical equipment must sign a contract with an establishment in Vietnam capable of providing warranty services on medical equipment as registered under the owner's name. Exception to this are disposable medical equipment.

**The establishment providing warranty services shall be certified by the owner of the medical equipment on products which are registered by the owner.




Edited by Jean Ngo