Dear Fellow Colleagues and Group Members,
Let me deliver my selection of highlights on the status of the regulation of medical devices in Russia in October.
- Draft of Multiple Amendments to Russian Medical Device Regulations
In October 2016, the Russian Ministry of Health published several draft documents (link in Russian) that are intended to implement significant changes into current key medical device regulations (i.e., Federal Law 323 and Resolution #1416). In general, the trend of proposed changes is in line with Eurasian medical device harmonization. The key suggested changes are:
- extended validity of the “old” forms (issued before 2013) of medical device registration certificates until December 31, 2021;
- allowance of official consultancy from Russian medical device regulator and expert organizations for applications to register medical devices;
- simplified procedure of registration expertise of in-vitro diagnostic (IVD) products (single stage examination rather than the current two stage process);
- implementation of mandatory annual reporting to Russian authorities of information regarding efficiency and safety data for class IIb and III medical devices within three years of registration approval;
- implementation of mandatory regular reporting to Russian authorities of information on lot/batch numbers of class IIB and III sterile single-use medical devices and class IIB and III IVD products;
- implementation of “180 day rule” after submission or notification of changes in the registration dossier. Medical devices that are manufactured within 180 days of date of approval of changes in the registration by the Russian regulator can be legally imported and circulated in Russia according “old” registration dossier (before changes are approved) .
Published documents are currently undergoing public and expert evaluation and they are expected to come into force by the end of the year.
- List of Implantable Medical Devices: New Version
On 22 October 2016, the Russian Government extended the list of medical devices that can be implanted into the human body, subject of state healthcare programmes (link in Russian). Compared to the previous version of the list, 160 new medical devices have been added and some old devices have been removed (devices that were not implantable, as classified according to current nomenclature).
Recall that, in accordance with Russian Federal Law №323-FZ, prices for implantable medical devices that are included in state programs and that are included in the list are subject to the state regulation.
The first version of the list, which included 202 medical devices, was published in 2014.
Guidelines (link in Russian) for determining the maximum wholesale mark-up that could be made to the actual selling price of medical devices implanted into the human body were approved and published in 2015.
In August 2016, the deadlines for implementation of price regulation were postponed for one year.
- New Fees for Amendments to the Registration Dossier
Another draft regulation regarding state fees for amendments to the registration dossier was published (link in Russian) by the Russian Ministry of Health in October 2016. Currently, amendments to the registration dossier (according to Clause 55 of Russian medical device registration rules) are free for applicants and mandatory when technical or quality characteristics of the approved medical device are changed. The new document implements the following fees:
– amendments to the registration dossier for a medical device – 3,500 rubles (55 USD)
– procedure of expertise of amendments to the registration dossier 30,000 rubles (460 USD) – 55,000 rubles (850 USD), depending on the safety class of the device.
The objective of this blog is to make Russian and Eurasian regulations more clear. Please post your comments and questions here or on the Russian medical device regulations LinkedIn group. You can also follow me on Twitter @MedDevRus.