Medic Consulting Solutions
UTS Danışma has been providing licensing and consultancy services for medical devices, cosmetics, and chemical products since 2016. They specialize in product registration, certification, and compliance with Turkish and international regulations, supporting manufacturers, importers, and distributors in navigating complex regulatory processes. Their services include product registration, certification, compliance consulting, and import consultancy, with a focus on medical devices, cosmetics, and chemicals. They aim to save clients time and money, protect against product risks, and ensure regulatory compliance for smooth market entry and product management.
Industries
Nr. of Employees
small (1-50)
Medic Consulting Solutions
Services
Regulatory consulting and dossier preparation for market authorization and ÜTS registration of medical devices, including label and manual drafting and submission support.
Management of product registrations, document uploads, and system transactions within the national ÜTS portal for medical devices and cosmetics.
Guidance on conformity assessment selection and documentation needed to support CE marking activities for applicable product categories.
Support for registering diagnostic kits and arranging required sample delivery to public health evaluation centers for conformity and performance evaluation.
Formulation evaluation, Product Information File compilation, Turkish labeling and ÜTS registration services for cosmetic products.
Strategic planning for chemical registrations, determination of scope/exemptions, preparation of registration dossiers, Chemical Safety Reports, Safety Data Sheets (SDS/e-SDS), and support for representative, third-party representation, SIEF and consortium management.
Regulatory consulting and dossier preparation for market authorization and ÜTS registration of medical devices, including label and manual drafting and submission support.
Management of product registrations, document uploads, and system transactions within the national ÜTS portal for medical devices and cosmetics.
Guidance on conformity assessment selection and documentation needed to support CE marking activities for applicable product categories.
Support for registering diagnostic kits and arranging required sample delivery to public health evaluation centers for conformity and performance evaluation.
Formulation evaluation, Product Information File compilation, Turkish labeling and ÜTS registration services for cosmetic products.
Strategic planning for chemical registrations, determination of scope/exemptions, preparation of registration dossiers, Chemical Safety Reports, Safety Data Sheets (SDS/e-SDS), and support for representative, third-party representation, SIEF and consortium management.
Expertise Areas
- Medical device regulatory submissions and national market authorization (Turkey)
- National product tracking system operations and compliance (ÜTS)
- Cosmetic regulatory compliance and Product Information File (PIF) management
- Chemical registration and compliance under KKDIK (Turkish REACH) including SDS and Chemical Safety Reports
Key Technologies
- National electronic submission portals (ÜTS, EBS, customs e-systems)
- GS1/GTIN barcode assignment systems
- Regulatory dossier and technical file compilation processes
- Product Information File (PIF) compilation for cosmetics
News & Updates
Participation in MDR transition process training organized by SADER Academy.
Information session on the new Medical Device Regulation (MDR).
Participation in the general information seminar on MDR.
Participation in the Product Tracking System briefing meeting.
Participation in MDR transition process training organized by SADER Academy.
Information session on the new Medical Device Regulation (MDR).
Participation in the general information seminar on MDR.
Participation in the Product Tracking System briefing meeting.