TECHNICAL REGULATION ON MEDICAL DEVICES

Assessment of compliance of medical devices and equipment
– assessment process of medical equipment to the requirements of the technical regulation on medical devices according to the decree of the Cabinet of the Ministers of Ukraine dated 02.10.2013 №753 (medical devices, medical equipment), or 02.10.2013 №754 (medical devices in vitro), or 02.10.2013 №755 (implantable medical devices).
Compliance certificate for medical devices and equipment may be executed on:
— commercially available product (certificate validity term in the case is 5 years);
— product batch (under an invoice).
The assessment process of medical devices and machines (medical equipment) consists of several major stages (full cycle or, in other words, execution of a batch compliance certificate):
— development of quality system (creation of quality guideline);
— conduct of preclinical studies (see more details in section Preclinical studies);
— enterprise audit for compliance of a complex quality management system in product manufacture;
— clinical evaluation or clinical studies (see more details in section Preclinical studies);
— issue of a certificate of compliance with the technical regulation.
Every enterprise should undergo all abovementioned stages in commercial assessment of medical devices and machines (or medical devices).
Specialists of our company will help you to get a minimum set of documents which is necessary for the launch of working activity on assessment of compliance of medical devices and equipment (or a medical device) to the technical regulation.
Execution term of a batch compliance certificate of medical devices and equipment: 1-2 months.
Execution term of a lot compliance certificate of medical devices and equipment: 1-2 weeks
Other registration services:
• Registration of cosmetic products
• Drug registration
• Registration of disinfectants
• Registration of biologically active additives
We work in all regions of Ukraine, call right now and get the European quality of service in available prices — ‎0994700483

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