Monthly Archives: September 2017

Three Things You Should Know about Medical Device Regulations in Russia, September 2017

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Dear Colleagues and Group Members,

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

 

  1. Development of Eurasian Medical Device Regulations

 

On 4 September 2017, the Eurasian Economic Commission published Recommendation No. 17, (link in Russian) ‘On the list of voluntary national standards that […] ensure conformity of a medical device with the Eurasian Essential Requirements for the Safety and Efficiency of Medical Devices’. The document harmonises existing national standards (155 voluntary standards for different types of medical devices and 43 standards for in-vitro devices) of the member states of the Eurasian Union and correlates them with the relevant requirements of the Essential Checklist.

In addition, earlier in September a number of drafts concerning medical device classifiers were published by the Eurasian Commission:

  • classifier of changes in the registration dossier of a medical device (link in Russian)
  • classifier of documents in the registration dossier of a medical device (link in Russian)
  • classifier of medical device area of usage (link in Russian).
    Usage of codes of the above classifiers are expected to be mandatory across several steps of medical device turnover in the Eurasian Union

At the same time, Roszdravnadzor (the Russian medical device regulator) created on its website the section ‘Registration of medical devices within the framework of the Eurasian Economic Union’, in which all Eurasian medical device regulations that came into force at that time were summarised.

Despite all published regulations, as of the end of September 2017, applications on Eurasian medical device registration process are still not working.

 

  1. Russian Ministry of Finance Clarified Rules for Medical Device Tax Exemptions

On 11 September 2017, the Ministry of Finance of the Russian Federation published a letter # СД-4-3/1794 (link in Russian) in which it recalled the rules for exemption from value added tax (VAT) when selling medical devices in Russia.

The regulator also confirmed the same VAT exemption for both ‘new’ and ‘old’ registration documents for the period 1 January 2017 to 30 June 2017 (i.e. the period before the amendment of the Russian tax code).

In this context it should be recalled that in February 2017, the Russian government published Resolution #160 (link in Russian) and extended to 1 January 2021 the deadline for the administrative replacement of the ‘old’ Russian medical device registration certificates.

 

  1. Medical Devices Incorporating a Medicinal Substance – Difficulties in Registration in Russia*

The registration of borderline products and medical devices with ancillary medicinal (pharmaceutical) substances is now one of the most pressing regulatory problems in Russia.

Resolution (Order) #11 N of the Russian Ministry of Health (link in Russian), which came into force in March 2017, requires the mandatory registration of all such chemical or pharmaceutical components as pharmaceutical substances in the Russian Federation.

On 25 September 2017, 38 manufacturers and distributors of medical devices in Russia submitted a collective letter to Russian medical device regulator Roszdravnadzor, the Ministry of Health, and the Ministry of Industry and Trade, in which they drew attention to serious difficulties with, and in some cases the impossibility of, state registration of whole groups of medical devices (for example, dental cements and adhesives, drug-eluting stents, cosmetic fillers…) under new requirements.

The petition contains an analysis of the current regulations of borderline products and medical devices with ancillary medicinal (pharmaceutical) substances, as well as a request to regulators to clarify their position on this issue and correct contradictions in legislation. The issue has received wide coverage in the Russian media.

 

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* I would like to express my thanks to Medrelic – a Russian consulting company for the registration and certification of medical devices – for kindly providing material and sharing expertise on issues regarding the registration of medical devices incorporating pharmaceutical substances.

Some Practical Questions on Ukrainian Medical Device Declaration of Conformity

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Improve Medical – the conformity assessment body based in Kyev kindly agreed to clarify some practical aspects and peculiarities of passing of medical device conformity assessment in  Ukraine:

 

  1. Can an authorized representative (AR) of a non-resident manufacturer draft and sign a declaration on conformity of medical device on its behalf?

 

According to Art. 28 of the Law of Ukraine “On Technical Regulations and Conformity Assessment” (hereinafter, the Law), the AR can draft and sign a declaration on conformity of a medical device with technical regulations (TR), but only on behalf of and under  responsibility of the manufacturer. For this purpose, the AR must have the properly authorized powers in the territory of Ukraine. As a rule, such powers are specified in the contract between the manufacturer and the AR.

If the conformity assessment procedures are applied by auditing the quality management system in accordance with Appendices III, VI and VII, then the declaration is drawn up and signed only by the manufacturer. In some cases and in the presence of a power of attorney, a representative office in Ukraine of a non-resident producer may also sign the declaration.

  1. Can the AR formalize the declaration in two languages ​​simultaneously with a single document?

According to Art. 28 of the Law, the declaration must be drawn up in the Ukrainian language, or necessarily translated into Ukrainian. From time to time, non-residents refuse to sign a declaration drafted only in Ukrainian, therefore, we recommend to draft and sign a single declaration in two languages (e.g. English and Ukrainian).

  1. Sometimes the regulatory authorities demand the seal of the conformity assessment body CAB to be affixed on the declaration. Is it necessary to certify the declaration of conformity in the CAB?

According to Art. 28 of the Law, the manufacturer, by drawing up the declaration, assumes responsibility for conformity of the products with the requirements of the TR. In this case, the TR does not set forth the structure or form of the declaration. According to Art. 41 of the Law, the responsibilities of the CAB do not include the need to approve the declaration. Thus, the declaration is signed only by the manufacturer and is not registered by the CAB. The requirement of the competent authorities for the seal of the CAB on the declaration is groundless.

  1. Who should approve translations of sample instructions for use, external labeling and other technical documents, if the manufacturer is a non-resident of Ukraine?

Ukrainian medical device technical regulations (TR) specify that information for users or consumers of medical devices should be stated in the Ukrainian language. However, the Law and the TR do not specify the responsibilities of the CAB for determining the quality of the translation, including the label and instruction. It means that the manufacturer submits such information in Ukrainian on its own responsibility.

The requirement to present information in Ukrainian language also applies to records and correspondence that accompany the conformity assessment procedure. However, there is no requirement in the TR to approve the translation of such information, and there are no restrictions as to who makes the translation.

Records mean documents drawn up by the auditor during the assessment process. Correspondence, as the application for conformity assessment, must also be executed in Ukranian. Documents of the quality management system may be provided to the CAB in a foreign language. However, note that the market surveillance authorities may require translation of the documents.

 

 

The answers were provided by Tatyana Pazerskaya, Director and Chief Auditor of IMPROVE MEDICAL – Conformity assessment Body which performs  conformity assessment with the Ukrainian technical regulations(regulations #753, 754, 755) for medical devices, active implantable medical devicesand in vitro diagnostics.

Russia Opens Pre-submission Consultancy for Medical Device Manufacturers

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On 10 September 2017, the order #6478 (link in Russian) came into force.
This order introduces pre-submission consultations from Russian regulatory expert centers involved in the registration process to medical device manufacturers for requesting feedback prior to start registration, local testing or submitting a medical device application to Roszdravnadzor (Russian medical device regulator) as far as discussing specific aspects of the Russian regulatory process and requirements (e.g. medical device classifications and designation of a product to medical device regulations).

Until now, Russian law did not allow such forms of consultancy, and direct communication between manufacturers and authorities on any specific question was formally prohibited.

Consultations will be paid for medical device manufacturers but not mandatory for obtaining approval.

Three Things You Should Know about Medical Device Regulations in Russia, August 2017

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Dear Colleagues and Group Members,

Here is my monthly newsletter with the most important regulatory updates on medical devices in Russia for August 2017.

 

  1. Restrictions for Plastic Consumables

In August 2017, the Russian government introduced two important regulations affecting public procurements of a broad range of medical devices made from polyvinyl chloride (PVC) plastics.
According to Resolution # 967 (link in Russian), which came into force on 25 August 2017, suppliers to the Russian market of medical devices manufactured with PVC will from now on be determined from the list of organizations implementing projects to localize the production of medical products in Russia in 2017–2024. The Resolution also sets rules for selecting such suppliers. In particular, organizations must have the right to technical documentation for the respective devices for a period of not less than ten years, and use technologies and raw materials developed within the framework of the Russian “Development of the pharmaceutical and medical industry” programme for 2013–2020.
At the same time, another adopted Resolution # 968 (link in Russian) includes six groups of disposables made of PVC plastics in the list of medical products for which state procurement from foreign manufacturers will be limited  (according to the Resolution #102 dated from February 2015).

 

 

  1. Draft Resolution on Changes to Russian Medical Device Registration Rules

The draft Resolution on Amendments to State Registration of Medical Devices is another important document which was published (link to the draft in Russian) at the beginning of August 2017. The main change proposed in the draft is a simplification of registration of in-vitro diagnostics (IVD): by analogy with the simplification of procedures for I class devices introduced in 2015, the document proposes one-step expert assessment (so called expertise) for registration instead of the current two-step pathway. Another possible innovation proposed in the draft is a significant change of procedure in the amendment of registration certificates and registration dossiers (product re-registration): it proposes a list of changes which do not require expert assessment for re-registration, and establishes a timeline for such re-registration as 15 working days.
As of the end of August 2017, a draft of the document is undergoing regulatory impact assessment by Russian authorities.
 

  1. Adopted Changes in Alcohol Regulations will affect some Medical Devices

On 29 July 2017, Russian authorities adopted Federal Law № 278-FZ (link in Russian), which changes measures to control the turnover/distribution of pharmaceutical substances of ethyl alcohol, including in the production of alcohol-containing medical devices. The regulation defines “alcohol-containing medical device” as a medical device in a liquid form, containing a pharmaceutical substance of ethyl alcohol (ethanol). The published law requires, in particular, additional registration and declaration procedures for legal entities that carry out the manufacturing and turnover/distribution of alcohol-containing medical devices in Russia. According to the regulation, lists of exceptions are established, i.e. “alcohol-containing medical devices” not covered by this regulation. These changes will become operative from 1 January 2018.

 

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