- 1- Вы задавались вопросами:
- 21. «Можно ли, внести изменения в РУ 2006 г.?»
- 22. «Требуется ли, переоформление РУ при смене организационной формы?»
- 23. «Как присвоить вид медицинского изделия в соответствии с Приказом № 4н от 06.06.2012 г.?
The number of innovative discoveries in medicine and biology increases every year. These vitally important inventions provide constant enhancement of properties and specifications of medical equipment. Modern innovations are being developed and produced using high technologies and require uniform international differentiation of labour, which is promoted by governmental and international organisations.
Not so long ago, the Eurasian Economic Commission (EEC) has ratified new requirements for QMS of medical products, which had been developed for formation of the unified market of medical products for member countries of EEU. Nowadays, this Union comprises 5 countries: Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan. Moreover, another 6 countries wish to join this union and are holding negotiations, 11 countries have expressed their interest, and 50 countries want to cooperate with EEU. In other words, this union has good prospects of development.
An it's not surprising as transfer to international standards grants a lot of advantages for development of not just particular enterprises manufacturing medical products but also for development of the area in the whole country.
The manufacturers which have registered medical equipment within the period from March 15, 2018 to march 15, 2019 have to prove availability of QMS fully compliant with requirements of EEU on their production site within 2 years since the date of registration of the medical product.
It's less than a year left for mandatory introduction of this system. As far as it's known, on March 6, 2018, decision of the Council of EEC No. 106 dated 11/10/2017 and specifying requirements for QMS of medical products was officially published. Than it became known that scheduled and off-schedule audits of production sites will start being conducted since March 15, 2019. That's why it's mandatory to introduce the quality management system on production site. Because after the above mentioned date, all medical products will have to comply with requirements approved by the Eurasian Economic Commission.
The decision was based on the ISO 13485 international standard but it has its own particularities and some differences. After the middle of March, 2019, audits will be conducted for compliance with requirements of Decision of the Council of EEC No. 106.
Therefore, introduction of quality management systems is mandatory for manufacturing and sales of medical equipment in Russia and in other countries of EEU.