THE BACKGROUND
The Republic of Kazakhstan is one of the world’s largest countries with a population of over 16 million people. The quickly growing economy in Kazakhstan has seen increased government spending in the health care sector since 2005, though regulations are undergoing changes as the Ministry of Health aims to improve the quality of health care.
Despite economic recession, the economy of Kazakhstan now ranks as the largest in Central Asia mainly due to its wealth of natural resources. Currently, more than 90% of the medical device market in Kazakhstan consists of products produced by foreign manufacturers.
“Recently, we have observed a readiness in the Kazakhstan authorities to invest in top quality devices and this has resulted in incentives to attract investment into the country,” commented Anna Gantman, Arazy Group’s expert on medical device registration in Kazakhstan and other countries in the Slavic world.
In 2013, Arazy Group initiated registration for over twenty medical devices in Kazakhstan from manufacturers in Germany, the Netherlands, Sweden, the United Kingdom, and the United States.
THE CHALLENGE
The registration process in Kazakhstan offers two main challenges. Firstly, Kazakhstan requires that user manuals be submitted in the official languages of Russian and Kazakh. The task of translating all documents and labelling for medical devices into Kazakh threatens complex and time-consuming work with additional cost, particularly as Kazakh is far from a commonly spoken tongue.
Secondly, documents must be submitted to the regulatory authority for an involved review process requiring extensive conversation and explanation of each aspect of the medical device. The review of the documents includes two stages: first, a review conducted by local experts; second, a review by a panel of doctors. With many other authorities, questions posed to manufacturers require a yes or no answer pertaining to this or that document. Not so in Kazakhstan, where reviewers want to glean an in-depth understanding of the device’s design and function before approving any documents.
Consequently, the regulatory professional communicating with the competent authority must have an exceptional level of knowledge of the device under review in order to provide the correct information to the reviewers. Regulators may ask for additional information or clarification from simple questions to complex mathematical inquiries. The regulatory professional is therefore required to provide a higher than usual level of attention and care to each license submitted in Kazakhstan.
Because of these factors, the timeframe for approval can be lengthened or shortened according to the preparation, quick response time, and attention of the regulatory professional in liaison with the regulatory authority.
THE PROCESS
The registration process requires that all documents (including CE Mark, QMC approvals (13485 and also 9001:2008), Declaration of Conformity, CFS, all technical files, etc.) be prepared for the Ministry of Health. Each device class requires the same documents with the exception of Class I devices, which do not undergo clinical review. While Kazakhstan does not offer expedited registration for devices that are already CE Marked, a CE Mark is required for approval along with a certificate of free sale (CFS) from the country of origin.
“We found that one of the greatest obstacles to smooth registration is the translation of documents into Kazakh and Russian, which is very time consuming. With the help of our local agent, we are able to help the manufacturer with the validation of terminology and label translation into Kazakh. This relieves a large part of the burden from our clients,” commented Gantman.
Once documents are submitted, local experts review the documents for approval. The documents are then sent to a panel of Kazakh doctors. The process usually involves substantial communication between each committee and the regulatory professional representing the manufacturer.
“Communication with the regulatory staff in Kazakhstan is always positive and they are always willing to help in the registration process,” said Gantman.
Most of this discussion usually takes place online, during which the reviewers begin a conversation with the manufacturer and/or representatives to understand the production and use of the device step-by-step.
“It is crucial to be engaged in the discussion with the competent authority,” continued Gantman. “In once instance, a client was asked to provide a sample of the device. Since the device was extremely large and heavy, I asked if there was anything missing from the documents to make such a complex request necessary. I realized from their explanation that they misunderstood an aspect of the device and I was able to provide the addition information in the form of photographs and further details. The sample was no longer required and they reviewed the documents again.
All in all, this delayed the registration process by one month, but it could have been much longer had we not addressed their concerns directly and with proactive action. I appreciated their flexibility in the requirements which allowed this matter to be resolved relatively quickly.”
The review process is divided mainly based on electric and non-electric devices. Time-to-market is approximately four months for electric devices and six months for non-electric devices.
However, after the license is issued, there are more steps to come. All documents must be submitted again to the Metrological Committee (KAZMEMST) to determine environmental impact when relevant. KAZMEMST establishes technical committees to develop standards in different fields of industry, including environmental standards. The aim of this committee is to approve measurement and technical standards of foreign devices and find that they conform to standards in Kazakhstan.
This additional step is usually complete in five months, before which the device can be legally shipped and sold as usual so long as the process has been initiated in parallel.
“This is a relatively new process and it is quite difficult to navigate,” said Gantman. “We have found that, on the whole, the most important part of registration is Kazakhstan is a solid and substantial relationship with local agents involved in the registration process.
With good connections and a detailed understanding of the process, manufacturers can avoid new requirements and lengthy delays. This can create challenges, but, if handled correctly, can offer an array of advantages over the more rigid requirements of other authorities.”
THE RESULT
In the past year, Arazy Group has obtained approval for twenty devices in Kazakhstan with six more pending approval.
“Most of the devices we have registered in Kazakhstan recently have been Class IIb and Class III devices, so we have developed an excellent connection with our local agents there in order to expedite registration for complex devices,” concluded Gantman.
Licenses in Kazakhstan expire after seven years. An authorized representative is not required in Kazakhstan, but the resource of a local agent is invaluable to a smooth and quick approval.
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