Recently, the round of public consultations has been completed in respect of the draft Bill “On Circulation of Medical Devices” (hereinafter – the “Bill”) posted in February 2013 on the website of the Russian Ministry of Economic Development.
The Bill introduces comprehensive regulation of relations connected with circulation, state registration, and quality examination of the medical devices.
Current general requirements to the circulation of medical devices are stipulated by several norms (Art. 38, 95, 96) of the Federal Law as of 21.11.2011 No. 323-FZ “On Fundamental Healthcare Principles in the Russian Federation” (hereinafter – the “Law 323-FZ”); certain clarifications are also provided by the range of normative acts of the Russian Government and Ministry of Healthcare. Nevertheless, current Russian legislation lacks consolidated normative act regulating issues of medical devices circulation at all stages.
The Bill proposes rather extended definition of the concept “medical device”, which generally reproduces the definition given in the effective legislation (Art. 38 of the Law 323-FZ). In particular, devices and equipment for medical purposes meet the criteria stipulated in that definition, but also certain software may be regarded as “medical device”.
State Registration of Medical Devices
According to the Bill, the circulation of medical devices is permitted within the territory of the Russian Federation, when they have been registered by the authorized federal executive body - Russian Federal Service for Supervision in the Sphere of Health Care (hereinafter – the “Roszdravnadzor”). Circulation of non-registered medical devices is prohibited.
State registration is not applicable to medical devices, their components and accessories, manufactured on the basis of the patients’ individual request and intended only for their personal use.
State registration will be made on the basis of technical trials’ results, toxicological examinations, clinical trials and examination of medical devices quality, efficiency and safety as well as trials for defining the type of measuring devices (in respect of medical devices being measuring equipment in the sphere of state regulation of measurement uniformity, the list of which is to be approved by the Russian Ministry of Health).
The Bill provides for detailed and multi-step procedural regulation for examination of quality, efficiency and safety of medical devices; whereas the clinical trials should be performed between the separate stages of such examination.
The general regulatory term for all stages of state registration of medical devices proposed by the Bill is 50 days. However, this term does not include time of clinical trials. Registration certificate for medical device should be issued upon completion of state registration, the data about registered medical device should be introduced in the special State register of medical devices and medical devices’ producers.
Requirements for Producers of Medical Devices
One of conditions for access to medical devices production is membership in self-regulated organization (hereinafter – the “SRO”) of medical devices’ producers. Except the producers, the requirement about mandatory membership in the SRO pursuant to the Bill applies to the organizations and entrepreneurs engaged in assembling, setting-up, repairing and technical service of medical devices.
Furthermore, producers of medical devices will also undertake to bring the quality management structure in compliance with requirements of GOST R ISO 13485. Presently, this national standard is applies on the voluntary basis.
Control and Liability Measures
The Bill contains provisions regarding control over circulation of medical devices which will allow Roszdravnadzor to take the certain measures aimed at protection of population from non-safe medical devices, prohibition of circulation of these medical devices and cancellation of their state registration. Forms and measures of state control are also established.
The Bill specifies rules of redress of an injury inflicted as a result of the use of medical devices. The liability for the injuiry may be imposed on producers of medical devices, on SRO as well as other persons who have violated provisions of the Bill.
It should be additionally mentioned that in respect producers of medical devices (their authorized representatives), organizations engaged in sales of medical devices the Bill introduces restrictions for interaction with medical and pharmaceutical employees, similar to those established for drug producers in the Art. 74 of the Law 323-FZ.
The Bill is currently passing through the approval stages within the Russian Government, upon completion of which it will be submitted to the Sate Duma.