All details we received when providing our services will be kept 100% confidential
The appropriate advice on Technical Regulations and the list of required documents
Representation at notified bodies, i.e. we hold negotiations, submit the set of documents, collect the comments, have the inspection procedure approved, make payments, etc.
Package labeling design
Drafting the Declaration of Conformity to requirements set forth by the Technical Regulations
WE OFFER THE FOLLOWING SERVICES:
The assessment of conformity of medical devices in Ukraine
July 1, 2015 witnessed some modifications in the statutory requirements that apply to approvals which must come together with the documents that support medical devices in order to ensure their commercialization in Ukraine, i.e. the system where marketing authorizations for medical devices were issued by the government has been replaced with the assessment of conformity to Technical Regulations approved via resolutions issued by the Cabinet of Ministers of Ukraine.
The service of the manufacturer’s authorized representative in Ukraine
Technical Regulations on Medical Devices obligate foreign manufacturers of medical devices to appoint an Authorized Representative in Ukraine before commercializing their medical devices:
“An authorized representative is either a corporate entity or an individual entrepreneur that/who is a Ukrainian resident or has been registered in accordance with Ukrainian laws, a representative of a foreign corporate entity that/who has duly approved powers to exercise legal arrangements related to the manufacturer’s obligations on behalf of the manufacturer” – Resolution No. 753 issued by the Cabinet of Ministers on October 02, 2013.
Self-declaration of medical devices
Self-declaring the conformity to technical regulations applies to:
– class I, non-sterile medical devices with no measuring function
– medical devices for in vitro diagnostics that are not mentioned in lists A and B of Technical Regulation No. 754 and are not self-monitoring devices.
Services for assessment of conformity at an authorized body
The assessment of conformity that involves an authorized body includes:
- certification of the quality management system utilized at manufacturing sites
which yields a conformity assessment certificate for medical devices (effective for 5 years) and a quality management system certificate (effective for 3 years)
- assessment of conformity of a shipment of products which yields a certificate applicable to a specific shipment (delivery) of medical devices. In this case the documents obtained from the manufacturer will be reviewed by experts, a standard sample of the medical device will be checked for conformity to technical documents, testing will be held which is obligatory to see whether the relevant standards preferred by the manufacturer have been observed. The shipment-wise conformity assessment does not apply to sterile products.