Hi,
State registration of medical device is an obligatory requirement for import, sale and marketing of device in Ukraine. State registration is performed centralized in Department of regulatory policy of medicinal products and goods of healthcare area of Ministry of Health of Ukraine that is located in Kiev.
Registered medical device is included to the State registry of medical devices of Ukraine. Registration certificate of medical device is issued for 5 years and can be renewed before expiry. Application for renewal of registration should be submitted not later than 90 days before the date of the expiry of registration certificate.
Structure of the registration dossier:
Following list of documents is required for registration of the medical devices in Ukraine [download in MS Word format] :
- Application
- Annex to Application
- Power of Attorney
- Instruction, user's manual, catalogues, technical characteristics.
- Certificate of registration of the medical device in manufacturer's country.
- Certificate of origin or/and Free sales certificate.
- Manufacturing license, other manufacturer's certificates.
- CE certificate (Certificate of compliance to Directive 93/42/ ЕЕС ).
- Declaration of conformity with mentioned safety class referred to Directive 93/42/ ЕЕС .
- Certificates ISO 9001; ISO 13485. Other standard compliance certificates .
- Protocols of the preclinical and clinical studies, other studies and scientific information.
- Certificates of analysis/quality. Certificates for starting materials (frames).
- Sterility certificate is applied, validation of sterility.
- Labeling information.
more info here:
http://www.cratia.com.ua/devices/newreg_eng.html
Regards,
Yana