Tag Archives: inspections

Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Economic Union, July 2018

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Dear colleagues,

This is a monthly update with my selection of highlights on medical device regulation changes and trends across Russia and the Eurasian Union.

1. The Eurasian Union: New Third-level Regulations Adopted

On 24 July 2018, the Eurasian Commission adopted and released two new third-level documents entailing Eurasian medical device regulations:

  • Regulation #116 (link in Russian) provides definitions, algorithms, and criteria for the registration of the spare parts, elements, modifications, components, and consumable materials of medical devices in the Eurasian Union;
  • Regulation #123 (link in Russian) provides criteria for inclusion (grouping) for registration for several modifications to a medical device in one certificate. The suggested criteria (e.g. dimension types, group specifications, or same analytes for in-vitro diagnostics) are applicable on the condition that the modifications to the medical device have the same safety/risk and Eurasian nomenclature classifications.

In addition to the documents released in May 2018 and September 2017, so far, six third-level Eurasian medical device regulations have been adopted overall.

2. Russia: Extension of the Restriction List (Draft)

On 24 July 2018, the Russian Ministry of Industry and Trade published a draft regulation (link in Russian) proposing a further expansion of the list that imposes restrictions on state purchases of medical devices from foreign manufacturers in favour of domestic manufacturers, according to Resolution #102. The published document proposed including six new types of medical devices in the restriction list: medical functional beds, concentrates for haemodialysis, tonometers for intraocular pressure, air sterilizers, dry air thermostats, and otorinoscopes.
Resolution #102 was introduced in February 2015 as a measure to support the “import replacement” programme and to promote the development of the domestic manufacturing of medical devices; since this time, the restriction list has been extended several times, in 2016 and 2017.

3. Russia: Updating Medical Device Inspection Checklists (Draft)

On 6 July 2018, the Russian medical device regulator Roszdavnadzor published a draft document (link in Russian) with amendments to the content of the check-lists used for routine inspections of medical devices manufacturers by the regulatory agency. The published draft document proposed removing from the checklist several questions concerning the use of the Russian language on external labelling and instructions for the use of the medical devices. Amendments to this document are due, given that Decree No. 1037 regulating the language requirements for non-food products in Russia was repealed in March 2018.
However, the removal of the questions about the Russian language from the check-list does not mean the repeal of the requirement for the use of Russian on external labelling and instructions for use for medical devices in Russia, which is currently regulated by other Russian and Eurasian documents.

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Three Things You Should Know about Medical Device Regulations in Russia, January 2018

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Dear Fellow Colleagues,

 

Welcome to my monthly newsletter with my selection of highlights in medical device regulations in Russia. Here are the most important updates for January.

 

 

  1. Road map to Development of Competition in Public Health Sector

 

On the 12th January 2018, the Russian Government published resolution #№9-р (link in Russian) with a roadmap to “developing competition in healthcare” for 2018–2019.
The published document contains a list of suggested strategic measures to develop competition in the public market for medicines, medical devices, healthcare services, and biologically active supplements in Russia, in the coming years.

A significant part of this document is devoted to changes in the regulation of medical devices expected in the next two years. Thus, among others, the following measures were suggested:

 

  • Development of the concept of medical devices of the “open” and “closed” types in terms of the possibility of using consumables or reagents from other manufacturers and the duty of the state and municipal customers to purchase medical products of an “open” type.
  • Development of the concept of the interchangeability of medical devices.
  • Introduction of a ban for manufacturers to set restrictions on the possibility of using consumables/reagents from other manufacturers.
  • Inclusion in the technical documentation for medical device information on the period of operation costs of technical maintenance and repair, costs of training medical personnel for the rules of application, and operation of the medical device.

 

The document also mentions a number of measures to improve and develop the regulation on the procedure of state and municipal procurement of medical products. The full text of the road map is available on the website of the Government of the Russian Federation.

 

 

  1. Checklists and Year Plan for Inspections

 

On the 26th January 2018, the Russian medical device regulator, Roszdravnadzor, published the approved forms of checklists (lists of control questions) that are used by the regulator during routine control inspections/audits of medical device manufacturers and other organisations involved in the turnover of medical devices in Russia.

In total, seven checklists have been published for the monitoring at each stage of the medical device lifecycle (control of pre-registration testing, clinical trials, usage and application in clinics, control of medical device manufacturers and its authorised representatives, technical maintenance, transportation, and storage). The checklists clarify whether organisations are complying with the mandatory requirements set by Russian medical device regulations and standards; they could also be a useful tool for audit preparation.

The list of organisations planned for inspection by Roszdravnadzor in 2018 has been published by the regulator in the beginning of January.
 

  1. Amendments to Regulation of Medical Products Containing Alcohol

 

On the 1st January 2018, article #14 of the Russian federal law #171 (link in Russian), the “regulation of turnover of ethyl alcohol, alcoholic, and alcohol-containing products” came into force. According to the updated regulations, Russian companies carrying out the production, manufacturing, and/or turnover of medical products containing alcohol exceeding 200 decilitres per year are obliged to register and declare this volume of alcohol-containing medical devices in accordance with the established procedure. The regulation defines an alcohol-containing medical device as “medical products in a liquid form of release containing a pharmaceutical substance of ethyl alcohol.”
Another amendment to this federal law was enforced in late December 2017 and establishes that until the 1st July 2018, non-declaring of this information by a company is not considered a violation.

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This is my non-commercial project whose objective is to make Russian and Eurasian medical device regulations clearer.
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