On January 1, 2020, the Government issued Decree No. 03/2020 / ND-CP to amend and supplement Clauses 5, 6 and 11, Article 68 (Transitional provisions) of Decree No. 36/2016 / ND-CP amended and supplemented in Decree No. 169/2018 / ND-CP on management of medical equipment. As follows:
For medical equipment of types B, C and D:
– If it is on the list of import licensing and has been granted in 2018, 2019, 2020, 2021: The license will continue to be valid until the end of December 31, 2021, and will be imported with The amount is not limited and not controlled by the Customs.
– If not on the list of those subject to issuance of an import license: Will continue to import until the end of December 31, 2021 on demand, no quantity limit, no need to certify that the medical equipment of Ministry of Health when carrying out customs clearance procedures.
For medical equipment of type A:
– If there is already a receipt of the application for approval of the applicable standard issued by the Department of Health: it will continue to be imported on demand, without quantity restrictions, without the need for a classification and a confirmation document that is necessary. medical equipment of the Ministry of Health when performing customs clearance procedures;
For medical equipment being in vitro diagnostic bio-products:
– If the import license was granted in 2018, 2019, 2020, 2021: The license will continue to be valid until the end of December 31, 2021, to be imported in unlimited quantities and without being Customs control.
– If the circulation registration certificate has been issued in accordance with the 2005 Pharmacy Law and the documents guiding the implementation of this Law, the circulated number will be valid until the end of the time stated in the registration certificate onions. Unless the circulation number is recorded to expire after January 1, 2019 and before December 31, 2021, the issued circulation will be valid until the end of December 31, 2021;
For ASEAN common technical dossier (CSDT):
– Will be applied from December 31, 2021. Accordingly, starting from December 31, 2021, establishments requesting for circulation no longer need to provide documents specified at Points g, i, m, Clause 1, Article 26 of Decree No. 36/2016 / ND. -CP.
Decree 03/2020 / ND-CP takes effect along with the signing date for issuance, which is intended for January 1, 2020.
Decree 03/2020 / ND-CP revises the previous Decrees on the transitional provision, which is very important for a legal document, helping us determine the specific time limit of import licenses, circulation registration papers previously issued for each type of medical equipment, which serve as a basis for organizations and individuals involved in production, trading, and import activities. import and provide medical equipment services to perform necessary tasks to maintain the relevant conditions, ensure compliance with the provisions of the law on management of medical equipment.