Marketing Authorization of Medical Devices: Acceleration is Possible
The issue on acceleration of procedure of marketing authorization of medical devices was discussed at a joint meeting of the Committee of the Chamber of Industry and Commerce on Entrepreneurship in Healthcare and Medical Industry, RUIE Commission on pharmaceutical and medical industry and RUIE commission on health industry. That subject was particularly important as from this year permanent MA certificates for medical devices and medical equipment ceased to be in force, unless MA holders managed to renew the marketing authorization.
The participants discussed the issue on introduction of amendments into the Resolution of the Government of the Russian Federation of 27.12.2012 No 1416 and introduction of accelerated marketing authorization procedure of high-tech medical devices, to be applied to products manufactured at the sites certified according to all standards. Besides, an issue on the need for accelerated approval of Federal Laws “On Making Amendments into the Federal Law “On Fundamental Principles of Healthcare of Citizens of the Russian Federation” and “On Drug Circulation” was also raised.
It was remarked that the most offers made by representatives of the Union of Associations and Enterprises of Medical Industry, were considered by the Ministry of Health in the draft of amendments to the Federal Law “On Fundamental Principles of Healthcare of Citizens of the Russian Federation” and in Resolution of the Government of the Russian Federation No 1416 “On Approval of Rules of State Registration of Medical Devices”. Besides, it was mentioned that the deadlines for renewal of marketing authorization certificates, issued before coming into effect of the Decree No 1416 will be prolonged to December 31, 2021.
It is also suggested that Roszdravnadzor will provide consultations for the procedure of marketing authorization of medical devices. Roszdravnadzor is preparing suggestions on introduction of an accelerated procedure of locally produced high-tech medical devices. An issue on changing terms “medical devices and medical equipment” to “medical devices” was also discussed, and it was recommended that Roszdravnadzor considers this prospect.