GXP is a reliable regulatory partner for success of your company on the Ukrainian market of medical devices.
We provide consulting services concerning medical devices and service of an Authorized representative for manufacturers non-residents of Ukraine. We will make a legal path to the Ukrainian market of medical devices for your business. We will become a part of your team and act on your behalf according to requirements of current law. Our reputation works for you.
GXP’s mission is to facilitate the process of legalization of medical devices for manufacturers non-residents of Ukraine and to create a legal way for new players to enter Ukrainian market of medical devices, that leads to a major breakthrough on the market in whole, protects customers’ and manufacturers’ rights.
Medical devices classification:
Preparation of an application and a set of documents for submission to a Conformity Assessment Body to approve a medical device’s class.
Conformity assessment support:
Individual approach; Involvement of experts according to peculiarities of devices; Recommendations on choosing a conformity assessment procedure; Communication with a chosen Conformity Assessment Body; Preparation of technical documentation (technical file) according to requirements of Technical regulations; Preparation of Declaration of conformity; Recommendations concerning labeling and instructions for use; Result of our work is a conformity assessment certificate!!!
Professional assistance in the process of placing on the market class I medical devices:
Preparation of a Declaration of conformity; Preparation of a Power of attorney and of an Authorized representative Agreement; Preparation of an application and a set of documents according to the MOH Order №122 as of 10.02.2017 on maintenance of Register of persons, responsible for placing on the market of medical devices, active implantable medical devices, in vitro diagnostic medical devices, forms of notifications, list of data, herein and access to them; Result of our work is entering your company to the register!!!
Project support from development of medical devices to placing them on the market:
Individual approach; Involvement of experts according to peculiarities of devices; Project plan development including determination of check points; Risk analysis; Assistance in choosing of subcontracting organizations for realization of non-clinical investigations, clinical investigations concerning determination of an expiry date, processes’ validation, etc. Preparation of a technical documentation; Development of a labeling and instruction for use; Support in the process of product certification in a chosen Body or introduction into the Register of persons, responsible for placing on the market of class I medical devices.
Execution of technical documentation:
Preparation of a document “Principal requirements”; Preparation of a harmonized standards list; Execution of technical documentation in Ukrainian according to requirements of a Technical regulation.
Execution of a Declaration of conformity:
Preparation of bilingual Declaration in English and Ukrainian with two Annexes: a list of products and a list of harmonized standards.
Consulting services concerning labeling of medical devices:
Labeling project development following requirements of the Law of Ukraine On maintenance of Ukrainian language as governmental, DSTU EN ISO 15223-1:2018 Medical devices. Symbols to be used with medical device labels, labeling and information to be supplied. Part 1: General requirements, the Law of Ukraine On protection of consumers’ rights, requirements of relative Technical regulation and other legislative requirements that can apply individually.
DSTU EN ISO 13485:2018 (development of QMS, implementation, certification support):
Pre-certification audit of the manufacturing site by a qualified expert; Preparation of a report, recommendations and a QMS implementation plan; Composition of a quality guideline, risk analysis etc. QMS implementation on the manufacturing site, maintenance of records, training of personnel, internal audit; Support of a QMS certification procedure in a chosen Certification body; Result of our work is a Certificate of conformity to requirements of DSTU EN ISO 13485:2018!!!
Custom-made medical devices (application submission to the State Service of Ukraine on Medicines and Drugs Control support):
Preparation of an application and a set of documents for custom-made medical devices according to the Annex 9 of TR No. 753 and its submission to the State Service of Ukraine on Medicines and Drugs Control; Preparation of a technical documentation for keeping by a manufacturer or an authorized representative.
Obtaining a permit from the State Service of Ukraine on Medicines and Drugs Control for realization of clinical investigations:
Preparation of an application and a set of documents concerning medical devices intended for clinical investigations according to the Annex 9 of TR No. 753 for their submission to the State Service of Ukraine on Medicines and Drugs Control; Preparation of a technical documentation for keeping by a manufacturer or an authorized representative.
Authorized representative for manufacturers non-residents of Ukraine:
Preparation of an Agreement and a Power of attorney concerning assignment of an Authorized representative Analysis of a technical documentation for conformity to requirements of Technical regulations. Preparation of a declaration of conformity Recommendations on labeling development according to the local law requirements. Review of complaints and claims from customers Reporting to market surveillance authorities on products that pose a serious risk according to requirements of the law of Ukraine on State market surveillance and control of non-food products and the law Ukraine on General safety of non-food products; Conduct an investigation in the territory of Ukraine on behalf of a manufacturer. Customs clearance support according to the obligations of an AR. Tender operations support, according to the obligations of an AR. Informing of conformity assessment authorities on any changes in the manufacturing process, labeling, declaration etc., according to requirements of Technical regulations; Submission of a set of documents to the State Service of Ukraine on Medicines and Drugs Control for entering to the Register of persons, responsible for placing on the market of medical devices, active implantable medical devices, in vitro diagnostic medical devices.
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GXP – YOUR AUTHORIZED REPRESENTATIVE IN UKRAINE
- Medical devices classification
- Conformity assessment support
- Professional assistance in the process of placing on the market class I medical devices
- Project support from development of medical devices to placing them on the market
- Execution of technical documentation
- Execution of a Declaration of conformity
- Consulting services concerning labeling of medical devices
- DSTU EN ISO 13485:2018 (development of QMS, implementation, certification support)
- Custom-made medical devices (application submission to the State Service of Ukraine on Medicines and Drugs Control support)
- Obtaining a permit from the State Service of Ukraine on Medicines and Drugs Control for realization of clinical investigations
- Authorized representative for manufacturers non-residents of Ukraine
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