Dear Colleagues and Group Members,
This is a monthly update with my selection of highlights for June 2017 on medical device regulation changes across Russia and CIS:
1. Ukraine Completely Switched to New Medical Device Approval System
1 July 2017 is the end of the transition period from the system of state registration of medical devices to the assessment of conformity with Ukrainian Technical Regulations No.753, No. 754 and No.755.
After this date, medical devices approved under the “old” procedure that were put onto the Ukrainian market before this date will be allowed for distribution without passing the conformity assessment procedure and without a conformity mark. According to new regulations, these products will be allowed to be on the market before the end of their shelf lives, but not for more than five years from the date of their introduction into circulation.
The new Ukrainian medical device approval system is currently very similar to the European medical device and In-Vitro Diagnostics (IVDs) approval process, however the CE mark itself does not entitle a product to be placed on the Ukrainian market without meeting the requirements of local technical regulations.
The new Ukrainian medical device conformity assessment procedure is defined depending on safety class. The most common ways of assessment today include audits of manufacturing sites or batch conformity assessments. Low-class medical devices are mostly self-declared.
Other important requirements of the new approval system include the mandatory appointment of authorised representatives of manufacturers in Ukraine and mandatory use of Ukrainian language on the product labelling.
At the end of June 2017, the Ukrainian state register of medical devices contained 3764 approved devices, while the website of the Ukrainian Ministry of Health listed 13 accredited notification bodies for medical devices and eight notification bodies for IVDs.
2. Deadline for Price Registration for Implantable Devices in Russia
Another important date on the Russian regulatory landscape is 15 July 2017 – this deadline was set by Resolution 1517 (link in Russian) for manufacturers of implantable medical devices and their authorised representatives to submit documents to Roszdravnadzor, the Russian healthcare regulator, for the registration of maximum sale prices for implantable medical devices included in the list for the programme of state guarantees for free provision of medical care (link to the last version of the list in Russian). A list of documents for price registration is defined in Clause 4 of the price registration rules (link in Russian). According to these rules, with proper preparation of the documents, a decision on the price registration should be taken by the regulator within five business days. Meanwhile, in June 2017 the Russian regulator started publishing information about “average-weighted” prices agreed with the Russian Federal Anti-Monopoly Service (FAS). Published prices were provided using a Russian nomenclature classification system.
3. Further Development of the Eurasian Medical Device Regulation Model
After the formal entry of documents at the second level of the Eurasian harmonised system for regulating the circulation of medical devices came into force in May 2017, this system continues to develop. Thus, in June 2017, the Eurasian Commission published drafts of a number of new third-level documents:
- On the classifier of the types of adverse events associated with the use of medical devices (link in Russian)
- On the classifier of kinds of documents of the registration dossier on a medical device (link in Russian)
- On the nomenclature of medical devices (link in Russian)
- On the Consultancy Committee on Medical Devices (link in Russian).
From today, documents are available as drafts, which remain under public discussion status until the end of July.
I would like to thank IMPROVE MEDICAL for providing updates on the development of Ukrainian medical device regulations. The IMPROVE MEDICAL conformity assessment body is based in Kyiv and performs conformity assessment with Ukrainian technical regulations for medical products.
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