30 May 2019
The development of the medical industry in the Russian Federation and the regulatory framework of the EAEU today are considered to be incompatible. None of the countries participating in the EAEU separately has no such tough regulations (in terms of finances, bureaucratic procedures, documents and requirements), as the ones established for the Union.
Yuri Matvienko, CEO of Medrelis Company, told PROVED-MEDIA why the local medical device manufacturers are faced with the toughest problems.
The EAEU regulations require separate registration procedures and certificates for all the medical devices launching on the market. This means that, for example, surgical instrument manufacturers should receive more than fifty registration certificates under the EAEU regulations — one for each type of product.
At the same time, according to the local rules of the participating countries, manufacturers receive one registration certificate for all types of instruments. The cost of the state duties within the EAEU only for the manufacturers of surgical instruments will amount up to RUR 11.6 million. For comparison, the state duty for registration of the same range of instruments according to the Russian national rules is RUR 52 000.
In accordance with EAEU regulations, when registering medical devices of 2b risk class and above, clinical trials on humans in two different clinics are mandatory. According to the national rules of the countries participating in the EAEU, clinical trials involving people are not required for the medical devices of this risk class.
The cost of conducting clinical trials in humans, for example, for a surgical laser (risk class 2b) is at least RUR 2.5−3 million in one clinic, but there have to be two such clinics. That is RUR 5−6 million. At the same time, manufacturers of similar products from other countries can be tested with human participation only in one clinic, the second one can be covered with the manufacturer’s clinical evaluation report.