Decree No.36/2016/ND-CP provides for the management of medical equipment, with detailed regulations in some contents such as classification of medical equipment; investment incentives for projects on production of medical equipment; requirements for production, sale, import/export of medical equipment; publication of applicable standards, labeling, inspection and calibration of medical equipment.

According to this Decree, the following entities must carry procedures for declaration of eligibility before they come into operation: organizations conducting classification of medical equipment; facilities manufacturing and trading medical equipment; organizations providing consultancy services on medical equipment technology; and organizations conducting inspection and calibration of medical equipment

Regarding the publication of applicable standards and registration for sale of medical equipment, there are three cases being exempted from declaring applicable standards or registering: (i) Medical equipment that is used solely for researching, testing or repairing medical equipment or guiding the use thereof; (ii) Medical equipment imported into Vietnam for assisting purpose or for displaying at a fair, exhibition or for product introduction or as a gift; (iii) Medical equipment produced in Vietnam solely for export or for displaying at an overseas fair or exhibition (Article 19).

With regard to the export/import of medical equipment, the Decree states that medical equipment which has been granted the registration number in Vietnam may be exported/imported on demand without limit on quantity and without approval by the Ministry of Health. Other activities, such as temporary import, temporary export or transit of medical equipment, and import of used medical equipment shall be carried out according to applicable laws. The Decree also provides for the cases in which import licence of medical equipment is required, as well as procedures to obtain that licence. Regulations regarding Certificate of Free Sale are also detailed in this Decree.

This Decree becomes effective since July 1, 2016 and annuls Clause 10 Article 12 of Decree No. 89/2006/ND-CP dated August 30, 2006.