Dear colleagues and group members,
Welcome to my usual update on medical device regulations in Russia and countries of the Eurasian Economic Union (EAEU). Here are my three highlights for April 2017:
- Lifting Political Barriers for the Launch of Eurasian Economic Union Medical Device Regulations
On 5 April 2017, the Kyrgyz Republic endorsed a law “On Ratification of the Protocol on Accession of the Republic of Armenia to the Agreement on Common Principles and Rules for the circulation of medical products within the EAEU”. According to the provisions of the Protocol, Armenia officially joins the above Agreement. Until this date, ratification of this Protocol was one of the main political factors hampering the full launch of the unified medical device market and regulatory model for EAEU countries. The law entered into force ten days after the day of its official publication.
In this way all the obstacles to beginning the work of a unified pharmaceutical and medical device market have been lifted and all the second-level EAEU medical device regulations (except the quality management system requirements which are not released by the Eurasian Commission yet) are de jure coming into force for all EAEU member states.
It will be recalled that in recent months official fees for the registration of medical devices according to the new Eurasian procedure were published in Russia, Belarus and Armenia.
- Statistics on Medical Device Registration in Russia
At the end of March 2017, Russian medical device regulator Roszdravnadzor published statistics on registration of medical devices for the year 2016. It was reported that 1,465 new medical devices had been approved (which is around 40% higher than the year before) – among them 559 (38%) products manufactured in Russia and 906 (62%) by foreign manufacturers.
According to the report, the number of registration refusals decreased by around 9% compared to the year before: the regulator reports 477 refusals with a similar ratio: 163 (34%) for local and 314 (66%) for foreign manufacturers. Roszdravnadzor evaluates the total number of registration refusals for the year as 15.2%.
- Quality Management System Inspections in Kazakhstan
On 3 April 2017 the Kazakh medical device regulator (the National Center for Expertise) published a memo (link in Russian) for medical device and pharmaceutical manufacturers clarifying the rules for organising quality management system (QMS) inspection for registration of medical devices and pharmaceutical products. According to the document, for medical device manufacturers QMS inspection is mandatory if a legal manufacturer has never been registered in Kazakhstan before or manufacturing facilities have not been registered in Kazakhstan before, or in cases when conducting an analytical examination is impossible due to the lack or high cost of product samples. The regulator reminds us that the decision about inspection can be taken at any time during the examination. The inspection is carried out within 2-5 working days on one manufacturing site. Valid ISO standard certification of the manufacturer is a necessary condition for the inspection. The Kazak regulator highlights that the manufacturer should: organise the inspection within 30 days after receiving official notification; pay all costs associated with the procedure; and provide translation of necessary information into Russian.
Thank you for following this blog! My objective here is to make Russian and Eurasian medical device regulations clearer. You can also follow my updates on Twitter @MedDevRus
After the entry into force of new medical device regulations in the Ukraine, foreign manufacturers were faced with a number of procedural questions. One of these questions is about the authorized representatives (AR) functions, powers and duties.
Improve Medical – the conformity assessment body based in Ukraine kindly agreed to clarify most actual aspects about AR. Let’s have most frequent questions answered in this post:
- Who may be the authorized representative for foreign medical device manufacturers in Ukraine?
According to of the Technical Regulations (cl. 2.13) the AR in Ukraine may be:
- legal person – a resident of Ukraine;
- natural person with status of an entrepreneur, a citizen of Ukraine;
- representational office of foreign manufacturer of medical devices in Ukraine;
- distributor of foreign manufacturer of medical devices in Ukraine.
- What documents are needed for the AR to undertake these obligations?
AR is appointed on the basis of an agreement (contract) or an arrangement in which it is necessary to specify duties and functions to be undertaken by the AR. As a rule these functions are as follows:
- to initiate on behalf of the manufacturer the assessment of the conformity to the Ukrainian technical regulation and to the QMS;
- to perform all related payment;
- to provide translation of technical documentation;
- to prepare package of documents for assessment procedures;
- to obtain certificates of conformity assessment from the certified bodies;
- to store the technical documentation and all certificates;
- to report to the manufacturer about adverse events/side-effects, found out as the result of the use of his products;
- to inform potential customers about technical and consumer properties of the manufacturer’s products;
- to inform the manufacturer about the amendments in Ukrainian regulations.
The right of the AR to reassign to the third parties the powers given to him by the manufacturer shall be also stipulated – but along with this, the AR bears the responsibility for actions of the third parties as for his own.The validity period of this contract is usually determined as not less than five years.
- What functions shall perform the Authorized representative?
The main function of the AR is the representation of interests of foreign representative in the territory of Ukraine and communication between the foreign manufacturer of medical products and Ukrainian market. It shall be understood however, that the term «Ukrainian market» means not so much marketing outlet itself, as bodies of assessment of the conformity, monitoring bodies, fiscal bodies etc. All functions, which the manufacturer assigns to his AR in Ukraine, should be stipulated in the contract.
- Is it necessary to sign a contract if the manufacturer assigns functions of the AR to his representational office or to the distributor?
If the Ukrainian party, according to the acting contract, has not powers of the AR, it is necessary to either issue the power of attorney, or conclude a separate contract or additional agreement to the acting contract.
- What risks are the most typical for manufacturer and AR?
Basic risks, as a matter of fact, are equal both for the manufacturer, and for his AR: Most commonly It is delays or failed procedure of the conformity assessment procedure which may postpone introduction of the medical product into the market, but also to cause penal sanctions on the manufacturer and his AR by the controlling bodies. Therefore the AR should make the choice of the body of assessment of the conformity of medical products to the Technical regulations extremely prudently.
- What about termination of the contract with AR?
Reasons for the termination of the contract should be stipulated in the contract. It should be, as a rule, non-fulfillment or improper fulfillment of the contractual obligations by the parties or the force-majeure circumstances. Usually the termination of the contract with AR shall not oblige the manufacturer to withdraw from the market the products put into the circulation (its lot), change its packing and undergo the procedure of the assessment of the conformity to the Technical regulations once more.
- May one authorized representative render services to several manufacturers of medical products?
Yes, it is possible and not prohibited by Ukrainian law. In this case the AR should, as a rule, notify all manufacturers, whose products he represents in Ukraine.
The answers were provided by IMPROVE MEDICAL – Conformity assessment Body which performs conformity assessment with the Ukrainian technical regulations (regulations #753, 754, 755) for medical devices, active implantable medical devices and in vitro diagnostics.