Dear colleagues and group members,
Traditionally, summertime is not a very hot season for regulatory updates, so I am glad to share these three important highlights for medical devices in Russia and the Eurasian Economic Union (EEU):
- Update on Eurasian Medical Device Regulatory Model
On 2 June 2016 the Eurasian Commission published final versions of two second-level pieces of legislation for the harmonized Eurasian medical device regulatory system:
- Rules for Biocompatibility Testing of Medical Devices (link in Russian)
- List of Medical Devices with Measuring Function (link in Russian)
As at the end of June 2016, ten out of thirteen final versions of the Eurasian medical device regulations have been published. The final versions of two of the most crucial documents – “Eurasian Medical Device Registration Rules” and “Guidance for a Quality Management System for Medical Device Manufacturers” are still under discussion between member states and are expected within the near future.
Recall that although the Agreement on Common Principles and Rules of Circulation of Medical Devices formally came into force at the beginning of 2016, the new system is still not working.
- Discussions around price registration for medical devices
Some implantable medical devices (i.e. intended for fixation, delivery or extraction of implants or preparation for implantation procedure) may be removed from the “List of Implantable Medical Devices for Medical Aid Provided to Citizens under the Programme of State Guarantees of Free Medical Care” and exempted from the mandatory requirement of price registration. In June the draft law (link in Russian) was prepared and sent to the Russian parliament for discussion and approval.
In this context it should be recalled that 15 July 2016 is the deadline set by the Russian medical device regulator Roszdravnadzor for manufacturers of implantable devices to provide the regulator with information about the prices of their products.
- Clear identification of the medical device is critical for proper registration
In June, the Russian press loudly reported a story illustrating an example from current Russian medical device regulatory practice. Because of revealed discrepancies in the Russian registration certificate, Roszdravnadzor deemed the medical devices as non-[properly]-registered, and after that banned products of the UK manufacturer and one of the market leaders in its segment (read more in English).
Over the last few years Roszdravnadzor has increased controls on medical devices and requires notifying about any changes in product name or technical parameters of a registered device to ensure consistency between the registration certificate and the previously submitted registration file. Moreover, in contrast to previous registration rules, which allowed common “family” or “umbrella” registrations, clear identification of the brand name and model of the medical device is mandatory for proper medical device registration.
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