Here is my usual monthly selection of highlights about what happened in the Russian medical device regulations landscape in May 2018:
- Simplification Requirements for Substance-based Medical Devices (draft)On 30 May 2018, the Russian Ministry of Health published a draft regulation suggesting the simplification of requirements for registration and pre-registration testing of substance-based medical devices in Russia.
According to regulation #11N, enforced in March 2017, one of the requirements for registration of medical devices with ancillary pharmaceutical substances is mandatory registration of the pharmaceutical component of the product in the Russian register of medicinal products prior to registration of the device. This became one of the most pressing regulatory problems in Russia and increased the number of registration rejections in 2017.
The amendments proposed in the published draft suggest replacing the requirement above with submitting ‘…documents on quality of pharmaceutical substance <…> taking into account the intended use of a medical device <…> and issued according to the regulation of the country of origin of this pharmaceutical component’. The published draft is now passing through the procedure of public discussions by the end of June 2018.
- Mandatory Multi-Central Clinical Trials for IIB and III class devices (draft)
Another suggestion of the published draft regulation is the expansion of the list of cases when clinical trials involving human subjects are required for medical device approval in Russia.
Currently, according to resolution 2N, registration of most medical devices in Russia is mainly based on evaluation of clinical data, and clinical trials involving human subjects must be conducted in accredited clinics after the approval of the ethics council in a limited number of cases: for new types of medical device; for new complex or unique or special methods of prevention, diagnosis or treatment; and in cases where the effectiveness or safety of the medical device are not confirmed in the evaluation of clinical data.
The published draft document tightens these rules and introduces a requirement for all medical devices of IIB and III classes to undergo mandatory clinical trials involving human subjects, to be conducted in at least two medical organisations under a single clinical trials protocol.
The same draft document also suggests the innovative new possibility of conducting on-site clinical trials in limited cases.
It should be also noted that the amendments suggested in the draft document would make Russian and Eurasian clinical trial requirements more similar. Proposed amendments are now passing through the procedure of public discussions by the end of June 2018.
- Clarification on application of a reduced tax rate for medical devices in RussiaAt the end of May 2018, the Ministry of Finance of Russia published a letter On the application of the VAT rate of 10 per cent for imported and sold medical products in Russia (link in Russian). In this letter, the regulator clarifies that the list of medical devices taxed at a rate of 10% is approved by Decree of the Government of the Russian Federation N 688 (link in Russian to the latest version, updated on January 23, 2018). This should be guided by the codes of medical products, determined in accordance with the nomenclature of Eurasian customs commodity code EAEU TNVED and Russian product classification code OKPD 2.