Pursuant to the Law on the Government Organization dated 19/06/2015; in consideration of the proposal of the Minister of Health, the Government promulgated the Decree on amending, supplementing Article 68, Decree No. 36/2016/ND-CP dated 15/05/2016 of the Government on the medical equipment management as amended, supplemented at the Decree No. 169/2018/ND-CP dated 31/12/2018 of the Government amending, supplementing some provisions of the Decree No. 36/2016/ND-CP dated 15/05/2016 of the Government on the medical equipment management.
Article 1: To amend, supplement clauses 5, 6, 11, Article 68 of the Decree No. 36/2016/ND-CP as amended, supplemented at the Decree No. 169/2018/ND-CP as follows:
1. Clause 5 is amended as follows:
“a) As to licenses for importing medical equipment that falls into Class B, C, D and licenses for importing in vitro diagnostic bio-products granted in 2018, 2019, 2020 and 2021, these granted licenses will be valid until the end of 31 December 2021 and the Customs Authorities will not conduct control of the imported quantity in such case, unless otherwise as specified in clause 1, Article 42 and point (d) of this clause.
Organizations, individuals trading in medical equipment are responsible for ensuring that the documents as specified in point (i), clause 2, Article 66 of this Degree are always in effect while the import licenses are still valid. In the case of failing to maintain the validity of the documents above, the organizations, individuals trading in medical equipment have the responsibility to notify the Ministry of Health to withdraw the granted licenses as provided for.
b) As to medical equipment that falls into Class A having receipts of application files to announce the applicable standards issued by the Medical Department to be imported to meet requirements, there is no limit in quantities, needing neither classification nor documents to confirm that they are medical equipment of the Ministry of Health when implementing customs clearance;
As to licenses for importing medical equipment that do not fall into the list to which an import license must be granted and having been classified as medical equipment in Class B, C, D by the classification organization announced by the Ministry of Health in the electronic information gate can continue to be imported until the end of 31 December 2021 to meet requirements, there is no limit in quantities, needing neither classification nor documents to confirm that they are medical equipment of the Ministry of Health when implementing customs clearance.
c) As to in vitro diagnostic bio-products circulation registration certificates granted under the provisions of the Pharmaceutical Law 2005 and the guiding documents of this Law, the granted circulation registration certificates will be valid until the expiry date recorded on the circulation registration certificates.
For in vitro diagnostic bio-products circulation registration certificates that expire after 1 January 2019 and before 31 December 2021, the circulation registration certificates granted will be valid until the end of 31 December 2021;
As to medical equipment as in vitro diagnostic bio-products for which circulation registration certificates have been submitted under the provisions of the Pharmaceutical Law 2005 before 1 January 2019 will be addressed in accordance with the provisions of the Pharmaceutical Law 2005;
As to medical equipment as in vitro diagnostic bio-products for which circulation registration certificates have been submitted in the period from 1 January 2019 until the end of 31 December 2021 will be granted import licenses in accordance with the provisions of the Pharmaceutical Law 2005 and be valid until the end of 31 December 2021;
Beginning to receive application files and issue circulation registration numbers for medical equipment manufactured domestically as from 1 January 2019. Circulation registration numbers are in effect from the date of issue.
d) Chemicals, insecticidal and germicidal preparations used in household and medical sectors with the sole goals of sterilizing medical equipment with circulation registration certificates granted if expiring after 1 July 2016 and before 31 December 2020 will continue to use such circulation certificates until the end of 31 December 2020;
Beginning to receive application files and issue circulation registration numbers for chemicals, insecticidal and germicidal preparations used in household and medical sectors with the sole goals of sterilizing medical equipment as from 1 January 2019. Circulation registration numbers are in effect as from the date of issue.
e) As to domestically manufactured medical equipment to which circulation registration numbers are granted, then the circulation numbers are valid to use until the expiry date as recorded on the circulation registration certificates. For circulation registration certificates that expire after 1 July 2016 and before 31 December 2020, the circulation registration certificates will continue to be used until the end of 31 December 2020”.
2. Clause 6 is amended as follows:
“6. Beginning to receive application files to announce standards applicable to medical equipment falling into Class A as from 1 January 2017 and receipts of application files to announce standards applicable in effect as from 1 July 2017; beginning to receive application for circulation registration of medical equipment falling into Class B, C, D as from 1 July 2017, and circulation numbers of medical equipment in effect as from 1 January 2022, unless otherwise as set out in points (c), (d), clause 5 of this Article.”
3. Clause 11 is amended as follows:
“11. ASEAN Common Submission Dossier Template (CSDT) will apply as of 1 January 2022. As from 1 January 2022, facilities requiring for the assurance of circulation numbers will not have to provide documents as set out in points (g), (i), (m), clause 1, Article 26 of this Decree.”
Article 2: Effectivity
1. This Decree comes into effect since the date of signing.
2. Clauses 5, 6, 11, Article 68 of the Decree 36/2016/ND-CP as amended and supplemented by the Decree No. 169/2018/ND-CP expires when this Decree comes into effect.
Article 3: Implementation Responsibility
Ministers, Heads of ministerial-equivalent bodies, heads of governmental agencies, Chairpeople of People's Committees of provinces, cities directly under the Central Government are responsible for the implementation of this Decision.
Source: Vietnam Ministry of Health (MoH).
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