Tiếng Việt
The amended Decree is issued to amend and supplement a number of articles of Decree No. 98/2021/ND-CP, which has been regulated by Decree No. 07/2023/ND-CP. The goal is to remove difficulties, ensure openness in the management, import and circulation of medical equipment, and improve the efficiency of state management in this field.
Goal
The Decree aims to ensure effective, flexible and transparent management of medical equipment, contributing to meeting the increasing health care needs of the people.
Amendments and supplements
- Import licenses issued from 2018-2021 (except for in vitro diagnostic biologicals) are extended to 30/06/2025.
- In vitro diagnostic biologicals are extended until June 30, 2025, with no limit on the number of imports.
- Importing organizations must ensure compliance with the law, take responsibility for quality and purpose of use.
- Class C and D medical devices do not need an import license and can continue to be imported until June 30, 2025, with no restrictions on quantity.
- The registration number issued from 2014-2019 for in vitro diagnostic biologicals is extended until 30/06/2025.
Download the draft details here:
https://medgate.vn/wp-content/uploads/2024/12/Du-thao-thong-tu-98.pdf
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