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How soon should we wait for the release of the Russian version of ISO 13485?

Traditionally, several months pass between the release of the main international version developed with the participation of representatives of many countries and the publication of a fully adapted for Russian realities version of the GOST ISO standard.

In theory, we should wait for this release in the nearest future.

However, the fact remains - GOST ISO 13485: 2016 in Russia is almost not expected.

In general, the previous versions of this standard were not welcomed in our country with special respect.

However, one should not think that the matter is in some kind of neglect of our compatriots to the safety of medical equipment. The fact is that the basic control over such things in Russia is entrusted to Roszdravnadzor, which is entitled to issue its Registration Certificates for proven products.

And these documents are just mandatory in Russian. They are extremely difficult to obtain and highly appreciated by manufacturers.

That’s why manufacturers of medical equipment can strive to obtain an additional ISO 13485 only for the sake of the opportunity to trumpet this fact before customers.
However, it should be noted that such a trump card often comes winning, as it allows to reach more favorable terms of contracts.

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