Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union – June 2019

 

Dear colleagues,

Welcome to my usual monthly review containing the most important medical device regulation changes across Russia and the Eurasian Union over the past month:

  1. New Restrictions on State Procurements for Certain Medical Devices in Russia

On 26 June 2019, the Russian government published Resolution # №813 (link in Russian) and extended the list “of certain types of medical devices originating from foreign countries subject to restrictions for state and municipal procurements in Russian Federation”. 

The state procurement of medical devices included in the list, according to the Resolution #102 introduced in 2015, will be closed to foreign manufacturers if at least two bids on medical devices from local manufacturers (Russia, Kazakhstan or Belarus) were submitted for tender.

Above-mentioned Resolution # №813 has added 14 new types of device to the restriction list including ventilation devices, gamma-therapeutic radiation complex, ultrasound devices, certain types of endoprosthesis, external fixation devices, medical beds, intraocular lenses, intraocular tonometry, micro sources with iodine-125, certain adhesive dressings and surgical materials, medical devices for storage and transporting biological samples, air sterilisers and dry air thermostats.

According to the published document, analogs of each of these products are currently produced in Russia in sufficient volume by at least two local companies. The decision was taken with the aim of supporting the development and production of these products in Russia.

The new revision of the list is available in Russian.

  1. Russian Ministry of Health Clarified Trademark Requirements for Medical Device Registration 

The requirement to provide confirmation of the legitimate use of the Russian trademark for registration of a a medical device is a relatively new requirement, which was introduced by the Resolution 633 in June 2018 and raised a lot of questions and confusion across registration applicants over the last year.

Thus, according to the petition initiated by Russian medical device registration consulting company Medrelis and 28 medical device companies submitted to the Russian Ministry of Health in May 2019, over the past year the interpretation of trademark legitimacy by Russian health care regulator Roszdravnadzor was often controversial and led to additional difficulties in the registration procedure and an increased amount of registration rejections.

On June 2019, the Russian ministry of health, for the first time since the enforcement of the new trademark requirements, clarified (the letter kindly provided by Medrelis) that Roszdravnadzor, to prevent the circulation of counterfeit medical devices, may compare (verify) information provided <for registration of a medical device> by the manufacturer or the authorised representative of the manufacturer (s) with information received, inter alia, as “interdepartmental information interaction” (which means that missing documents confirming trademark legitimacy in the registration file may not be a reason for the registration rejection or additional requests to the applicant from the regulator).

  1. Multiple Updates of Regulations for Medical Devices and Pharmaceuticals in Kazakhstan

Kazakhstan continues to release multiple updates to local medical device and pharmaceutical regulations started earlier this year. Thus, for the past months the following regulations have been released in new revisions: 

  • On 02 May 2019 – the order KR-DCM 53 (Link In Russian) updating the rules of wholesale and retail sales of medicines and medical devices.
  • On 27 May 2019 – Order KR-DCM-88 (Link in Russian) updating pharmacovigilance requirements for pharmaceuticals and rules for safety monitoring of medical devices; 
  • On 7 June 2019 –the Order KR – DCM 82 (Link in Russian) updating requirement rules for assessing the safety and quality of medicines and medical devices registered in Kazakhstan;
  • On 9 June 2019 – the Order KR – DCM 87 (Link in Russian) updating rules of state registration, re-registration and amendments of the registration dossier for pharmaceutical products and medical devices.