Entering new global markets with your innovative Medical Device is an arduous task which needs scaling of several Regulatory procedural challenges. One such is to ensure the Regulatory compliance of your label and promotional material as per the requirements of the targeted country. Inherent technicalities like local language, usage of symbols and e-labeling requirements bring forth additional Regulatory hurdles.
In addition to the general labels, Instructions for Use (IFU) and marketing materials and Unique Device Identification (UDI) are some of the criterions to be taken care of for end-to-end compliance. Each country implies specific Regulatory nuances for these components. Hence, it is always a best practice to establish complete labeling Regulatory compliance for successful market entry.
As part of the end-to-end Regulatory assistance for market entry, Freyr facilitates organizations to comply with labeling and promotional material regulations wherein our experts guide manufacturers in creation and review of IFU, compliant UDI implementation, comprehensive artwork check, and regional language support etc.
- Create, update and review contraindications, warnings, and precautions
- Create, update and review Instructions for Use (IFU)
- Quality check of submission and commercial artworks
- Complete UDI Compliance solutions
- Gap Analysis between distributed labels and submitted labels
- Tracking and maintaining label changes
- End-to-end labeling support covering all aspects
- Qualified team of experts with hands-on experience across all categories of Medical Devices
- Regulatory support for handling region-specific complexities
- Extensive partner network across the globe
- Dedicated compliance team tracking the status of core and company core data sheet (CDS / CCDS) implementation in regional labels
- Structured approach to ensure 100% compliance