DECREE No.07/2023/ND-CP, Amendments and Supplements to Some Articles of Decree No. 98/2021/ND-CP December 08th, 2021 Of The Government On Management Of Medical Devices March 30, 2023 Decree of the Government of the Republic of Armenia N 429-N “On approval of the procedure for importing medical devices into the territory of the Republic of Armenia and the list of documents reIMPORTANT CHANGES IN DECREE NO.07/2023/ND-CP
1. Timeline of class C, and D registration change to 90 days after submission.
2. Fast-track submission: The number of times of amending and supplementing the dossier changed from 5 to 3 times. The dossier is canceled after 03 times to amend and supplement the dossier.
3. Import License issued from 2018 to 2021 under the old regime will remain valid for 02 additional years, until December 31st, 2024.
4. Medical device that is not on the list, which must be granted an import license and has a classification as a medical device of class C, D and is published on the website of the Ministry of Health, is allowed to continue to import until the end of December 31st, 2024.
5. CSDT is not a requirement until January 1st, 2024.
6. Only declare prices for medical equipment when an abnormal fluctuation in price affects the supply of medical equipment, the buyer's ability to pay, and the solvency of the Health Insurance Fund.
7. The Ministry of Health does not issue permits to import used medical devices.
8. Promulgating regulations to solve problems in handling medical equipment when the registration number is revoked.quired for examination carried out to import medical devices” was adopted and published, which will enter into force on July 1, 2023.