Dear: General Department of Customs
On May 15, 2016, the Prime Minister signed and issued Decree No. 36/2016/ND-CP on medical equipment management (hereinafter referred to as Decree No. 36/2016/ND-CP), effective from July 1, 2016. Accordingly, the management of medical equipment has important changes, specifically as follows:
Firstly, all medical devices must be classified as a basis for publishing applicable standards or granting registration numbers.
According to Article 4 of Decree No. 36/2016/ND-CP, medical equipment includes 2 groups divided into 4 types as follows:
– Group 1: includes medical equipment of type A
– Group 2: includes medical equipment of types B, C, D
The classification of medical equipment must be performed by a qualified organization and must comply with the classification instructions as prescribed in Circular No. 39/2016/TT-BYT dated October 28, 2016 detailing the classification of medical equipment, except in cases where the classification results are recognized according to Circular No. 42/2016/TT-BYT dated November 15, 2016 regulating the recognition of medical equipment classification results.
Second, medical equipment management is based on circulation numbers.
According to Article 20 of Decree No. 36/2016/ND-CP, the circulation number of medical equipment includes:
– Number of receipt of dossier for declaration of applicable standards for type A medical equipment according to form No. 03 specified in Appendix IV issued with Decree No. 36/2016/ND-CP. .
– Registration certificate number for medical equipment of type B, C, D according to form No. 09 specified in Appendix IV issued with Decree No. 36/2016/ND-CP. .
Medical equipment with circulation numbers in Vietnam can be exported and imported according to demand, without quantity restrictions and without having to be approved by the Ministry of Health.
To facilitate and support importing units in identifying and clearing imported medical equipment in the initial phase of implementing Decree No. 36/2016/ND-CP, the Ministry of Health (Department of Medical Equipment and Construction) respectfully requests the General Department of Customs to coordinate, direct and notify the Customs Departments of provinces and centrally run cities of the following contents:
Regarding import of medical equipment:
1. From 0:00 on July 1, 2017 to 24:00 on December 31, 2017:
a) For medical equipment classified as type A: Can only be imported after receiving a receipt of the application for declaration of applicable standards issued by the Department of Health of the province or city. In addition to customs documents, the importing unit when importing medical equipment must provide the following additional documents:
– Classification of medical equipment according to the form prescribed in Appendix V issued with Decree No. 36/2016/ND-CP or documents proving the results of classification of medical equipment according to the provisions of Circular No. 42/2016/TT-BYT dated November 15, 2016 regulating the recognition of medical equipment classification results.
– Authorization letter from the circulation number owner (in case the importer is not the circulation number owner).
b) For medical equipment classified as type B, C, D and included in the list of medical equipment issued with Circular No. 30/2015/TT-BYT dated October 12, 2015 of the Ministry of Health, the import of medical equipment can only be imported when meeting the following conditions:
– Has an Import License from the Ministry of Health according to Circular No. 30/2015/TT-BYT; ;
– Classification of medical equipment according to the form prescribed in Appendix V issued with Decree No. 36/2016/ND-CP or documents proving the results of classification of medical equipment according to the provisions of Circular No. 42/2016/TT-BYT dated November 15, 2016 regulating the recognition of medical equipment classification results.
c) For medical equipment classified as type B, C, D and not included in the list of medical equipment issued with Circular No. 30/2015/TT-BYT, the importing unit when importing medical equipment must provide an additional Medical Equipment Classification Form according to the form prescribed in Appendix V issued with Decree No. 36/2016/ND-CP or documents proving the results of medical equipment classification according to the provisions of Circular No. 42/2016/TT-BYT dated November 15, 2016 regulating the recognition of medical equipment classification results.
2. From 0:00 on January 1, 2018:
a) For medical equipment classified as type A: please follow the content stated in section I.1.a of this dispatch.
b) For medical equipment classified as type B, C, D: Can only be imported after having a certificate of registration issued by the Ministry of Health. In case the importer is not the owner of the circulation number, it must also provide a Power of Attorney from the owner of the circulation number.
3. For Invitro diagnostic medical devices that have been granted a circulation number before December 31, 2017: they can continue to be imported within the time limit stated in the license.
4. Guide and direct the Customs Departments of provinces and centrally run cities to look up the contents of the notification on the circulation number of medical equipment and import licenses on the National Single Window Portal to carry out customs clearance procedures for importing units, avoiding cases requiring re-confirmation in writing from the Ministry of Health to avoid congestion, reduce the time to release medical equipment goods and generate administrative procedures and sub-licenses.
Above are some related contents in the management of medical equipment to implement Decree No. 36/2016/ND-CP. We respectfully request the General Department of Customs to coordinate and direct to facilitate and support importing units in the process of customs clearance of goods. During the implementation process, if there are any difficulties or problems, please contact the Ministry of Health (Department of Medical Equipment and Construction) at phone number: 04.62732272, email: vuttbctyt@gmail.com for coordination.
Thank you very much for your cooperation with the General Department of Customs.