On 01 January 2020, the Government issued Decree 03/2020/ND-CP amending and supplementing Article 68 of Decree No. 36/2016/ND-CP dated 15 May 2016 on management of medical equipment amended and supplemented by the Governmental Decree No. 169/2018/ND-CP dated 31 December 2018 amending and supplementing a number of articles of Decree No. 36/2016/ND -CP dated 15 May 2016 of the Government on management of medical equipment.
Accordingly, Decree 03/2020/ND-CP amends and supplements Clauses 5, 6 and 11 of Article 68 of Decree No. 36/2016/ND-CP amended and supplemented by Decree No. 169/2018/ND-CP as follows:
Article 68.5 is amended as follows:
- The licenses to import medical equipment of classes B, C and D and licenses to import in vitro diagnostic reagents issued in 2018, 2019, 2020 and 2021 will expire after 31 December 2021 and be exempt from any import quantity limit imposed by customs authorities. (old regulations will expire on 01 January 2020)
- The import of medical equipment that do not require the import license and have been classified as B, C or D may be imported until the end of 31 December 2021 without limits and certification documents from the Ministry of Health. (old regulations will expire on 01 January 2020).
- The issued registration numbers of in vitro diagnostic reagents that expire after 10 January 2019 and before 31 December 2021 will be effective until the end of 31 December 2021. (old regulations will expire on 01 January 2020).
- Applications for the license to import in vitro diagnostic reagents that are submitted during the period from 01 January 2019 to 31 December 2021 inclusive will be approved in accordance with the 2005 Law on Pharmacy; such import licenses will be effective until the end of 31 December 2021. (old regulations will expire on 01 January 2020).
- Certificates of registration of insecticides and germicides of which sole purpose is to sterilize medical equipment which expire after 01 July 2016 and before 31 December 2020 will be effective until the end of 31 December 2020. (old regulations will expire on 01 January 2020).
- The certificates of registration that expire after 01 July 2016 and before 31 December 2020 will be effective until the end of 31 December 2020. (old regulations will expire on 01 January 2020).
Article 68.6 is amended as follows: applications for registration of medical equipment of classes B, C and D may be submitted from 01 July 2017; and registration numbers of medical equipment will come into effect from 01 January 2022. (old regulations from 01 January 2020)
Article 68.11 is amended as follows: The ASEAN Common Submission Dossier Template (CSDT) is applied from 01/01/2022, from which applicants for circulation numbers are not required to provide the documents stated Articles 26.1.g, 26.1.i and 26.1.m of this Decree. (old regulations falling on 01/07/2020)
Decree 03/2020/ND-CP takes effect from 01/01/2020 and partially invalidates Decree 169/2018/ND-CP.
