Due to the rapid growth of the COVID-19 pandemic, in view of the safety and well-being of the population, governments in the most countries of the world have introduced restrictive measures, including the introduction of a ban on passenger transportation, including air travel. Many countries have closed borders for foreign nationals.
Certification organizations around the world have faced a new challenge – the inability to assess quality management systems at manufacturers’ locations, ie the inability to conduct on-site audits. In turn, this has increased the threat of uninterrupted supplies of medical devices, including those needed to counter COVID-19.
In response to the circumstances, Uni-Cert, LLC introduced and agreed with the National Agency for Accreditation of Ukraine a mechanism for conducting remote audit (audit by telecommunication).
Carrying out remote audits is a temporary measure to provide our country with quality medical products during the COVID-19 pandemic and is limited by the period of force majeure in Ukraine and the world.
You can find out more about remote audit at our staff and at this link.
We would like to remind you that carrying out conformity assessment without conducting an on-site audit is also possible by applying the procedure of partial recognition of the results of conformity assessment work carried out by foreign accredited bodies. The procedure for the partial recognition of the results of works involves carrying out some of the work on conformity assessment with national CABs and recognizing the other part (protocols and reports) carried out by a notified body of the EU. The procedure is regulated by Article 45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment” and is a transparent and cost-effective way of authorizing medical devices from world manufacturers in Ukraine.
We recommend that you use a partial recognition procedure if possible. You can see the list of bodies with which the Uni-Cert, LLC has concluded recognition agreements here.
In addition, we inform that Uni-Cert, LLC and all our employees work in the regular mode, mostly remotely. All training events previously planned and published on our site will be held in webinar format. You can find the schedule of our webinars here.