1. Pursuant to Point b, Clause 1, Article 1 of Decree 03/2020/NĐ-CP dated January 1, 2020 of the Government amending and supplementing Article 68 of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on management of medical devices, as amended and supplemented by Decree No. 169/2018/NĐ-CP dated December 31, 2018 of the Government, it is provided that: “Class-A medical devices for which a receipt of the dossier announcing applicable standards has been issued by the Department of Health may be imported according to demand, without quantity restrictions, and without requiring a classification sheet or a Ministry of Health confirmation that the goods are medical devices when carrying out customs-clearance procedures.”

Accordingly, this provision concerns only customs-clearance procedures and does not address the conditions for applying the 5% value-added tax rate to specialized medical equipment imported by the company.

2. Pursuant to Clause 8, Article 1 of Circular No. 26/2015/TT-BTC dated February 27, 2015 of the Ministry of Finance, effective from January 1, 2015: “Medical equipment and instruments include machinery and instruments specialized for medical use such as scanning, projection and imaging machines used for medical examination and treatment; equipment and instruments specialized for surgery and wound treatment; ambulances; blood-pressure, cardiac and vascular measuring instruments; blood-transfusion instruments; syringes and needles; contraceptive instruments; and other instruments and equipment specialized for medical use as certified by the Ministry of Health.

Medical cotton, bandages and gauze and sanitary pads; preventive and curative medicines including finished drugs and pharmaceutical ingredients, excluding functional foods; vaccines; medical biological products; distilled water for preparation of injections and infusions; caps, clothing, masks, surgical drapes, hand covers, lower-limb covers, shoe covers, towels and gloves specialized for medical use; breast implants and dermal fillers (excluding cosmetics); testing chemicals and disinfectants used in healthcare as certified by the Ministry of Health” are subject to the 5% VAT rate.