The three matters for which enterprises requested confirmation from the Ministry of Health are: Class A medical equipment for which a receipt acknowledging the declaration of applicable Class A standards has been issued by a Department of Health; medical equipment classified as Class B, C or D and not included in the list in Appendix I of Circular 30/2015/TT-BYT of the Ministry of Health; and, third, cases where enterprises import components and raw materials to manufacture medical equipment.

Regarding this issue, Mr. Nguyen Minh Tuan, Director of the Department of Medical Equipment and Construction under the Ministry of Health, stated that pursuant to Clause 39 of Decree 169/2018/ND-CP amending Point b, Clause 5, Article 68 of Decree 36/2016/ND-CP dated May 15, 2016 on medical equipment management, Class A medical equipment for which a Department of Health has issued a receipt acknowledging the declaration dossier of applicable standards may be imported according to demand without quantity restrictions and without a written confirmation from the Ministry of Health that the goods are medical equipment when carrying out customs clearance procedures.

Medical equipment that is not on the list requiring an import license and has been classified as Class B, C or D by a classification organization whose information has been published by the Ministry of Health on its electronic information portal may continue to be imported through 31/12/2019 according to demand, without quantity restrictions and without a written confirmation from the Ministry of Health that the goods are medical equipment when carrying out customs clearance procedures.

Mr. Tuan stated that, pursuant to Clause 39 of Decree 169/2018/ND-CP supplementing Clause 13, Article 68 of Decree 36/2016/ND-CP dated May 15, 2016 on medical equipment management, materials, software, accessories and medical gases are not required to undergo circulation registration or import licensing.

“Thus, the matters raised by enterprises have been stipulated very clearly by the Prime Minister in Decree 169/2018/ND-CP. Therefore, the Ministry of Health will not provide confirmation for the medical-equipment import matters mentioned above,” the Director of the Department of Medical Equipment and Construction affirmed.