The Regulatory requirements vary at a global level, with every region, every Health Authority (HA) and every product category. Be it data requirements and integration, clinical trial phases and methodology, device classifications and UDI requirements, ingredient assessment and formulation reviews, data publishing and submission formats (either electronic or paper), every single procedure is unique and aligned with region-specific requirements. Given the intricacies of regional/local requirements, it is indeed a complex situation for manufacturers to ensure that they adopt the right path.
To access the market, manufacturers must obtain market approvals from their respective Department of Health Authorities. Apart from handling wide variety of complex manufacturing and clinical functions, navigating through critical Regulatory processes and Health Authorities requirements for various medicines and medical device categories might pose a great challenge for manufacturers while approaching for market authorizations.
The challenges for foreign manufacturers who are willing to enter Other Countries is to track and sustain the changes to register and obtain approvals for their medical devices or cosmetics in a cost-effective way
Freyr, as a specialist global Regulatory partner, assists foreign manufacturers in decoding the local regulatory requirements and comprehensive product classification based on relevant Health Authority Regulations. In addition, Freyr assists foreign manufacturers with mandatory Regulatory submissions for streamlined registrations and approvals. Freyr is capable to provide Regulatory services in 120+ Countries in various areas like:
- Medical Devices (neurosurgical devices, implantable, imaging products, and cardiovascular devices as well as wearables and electronic health products)
- Natural Health products
- Biologics/Bio Similar