Welcome to my monthly update on medical device regulations in Russia and countries of the Eurasian Economic Union (EAEU). Here are my three highlights for February 2017:
- Prolongation of old forms for registration certificates
On 14 February 2017, the Russian government released the Resolution 160 (link in Russian).
The key update on this resolution is prolongation of the deadline for the procedure of administrative replacement of “old” forms of Russian medical device licences issued before 2013.
Recall that, according to the Resolution 1416 of the Russian government issued at the end of 2012, registration certificates for medical products and medical equipment issued before the date of entry into force of the new registration rules (2013) were to be replaced under a special administrative procedure. Initially, entry into force of the measures was planned for 1 January 2014 and then was postponed until 1 January 2017.
The Resolution 160 extends these deadlines again for another four years – until 2021, in line with the end of the transition period for Eurasian medical device regulations.
Russian medical device regulator Roszdravnadzor says more than 10,000 registration certificates were replaced using this procedure from 2013 till 2016. Meanwhile from the other side industry experts assess that up to 10% of licences for medical devices on the Russian market were not updated on time.
The formal timelines for the administrative replacement procedure according to the Russian regulations is 30 business days; the process for application is described here.
- Official consulting from Russian medical device regulatory authorities
Another innovation introduced by the Resolution 160 is the possibility for official consultations on the medical device registration process on behalf of Russian regulatory expert centres involved in the registration process. The resolution addresses Russian medical device registration rules with relevant amendments (see clause 58.1), allowing medical device manufacturers to discuss with authorities specific aspects of the regulatory process and requirements.
Recall that previously, Russian law did not allow such forms of consultancy, and direct communication between manufacturers and authorities on any specific question was prohibited.
Considering that lack of transparency still remains one of the key challenges for regulatory professionals in the Russian medical device registration process, such possibility could be especially valuable for medical device manufacturers in the near future.
- Fees for Eurasian medical device registration procedure
On 22 February 2017, the Russian Duma released a draft federal law aiming to update the Russian tax code. Among other updates and amendments, the document introduces long-awaited information about amount of fees for a harmonized Eurasian medical device registration procedure.
The total proposed registration fee for a medical device consists of three parts:
a) Constant registration fee: 7,000 roubles (approx. 120 USD)*
b) Fee for the expertise: 45,000–115,000 roubles (750–1,800 USD)* depending on safety class
c) Fee for the “acceptance” procedure: 45,000–115,000 roubles (750–1,800 USD)* depending on safety class for each member state.
Today, lack of established fees for registration is one of the reasons why a harmonized EAEU medical device regulation model is still not working in practice. One can expect that proposed amendments will come into force from the second half of 2017 after approval of both chambers of the Russian parliament.
*RUR/USD rate provided for end February 2017
The objective of this blog is to make Russian and Eurasian regulations clearer. Please post your comments and questions here or on the Russian medical device regulations LinkedIn group.