The Asia Pacific (APAC) medical device market is proving to be very promising for clients amidst prevalent market conditions and in comparison, to existing traditional markets. APAC has a few stringent Regulatory agencies, which include the Pharmaceuticals and Medical Devices Agency (PMDA) Japan, the Ministry Of Food And Drug Safety (MFDS), South Korea, the Therapeutic Goods Administration (TGA), Australia and the Singapore Health Sciences Authority (HAS), Singapore. Though the region offers an enticingly low-cost manufacturing destiny, the wide spectrum of complex and evolving medical device Regulatory requirements may simultaneously pose a great challenge for market entrants, when they attempt to gain market approvals and authorizations.
With an exclusive delivery center in India and a robust existence in the APAC region in coordination with our local affiliates, Freyr brings to you the entire spectrum of Regulatory support services for medical device. Freyr simplifies your task of obtaining market authorizations and approvals as well as market devices in this emerging market.
- Device classification and registration services
- Quality Management System (QMS) compliance strategy
- Local representation services
- Health Agency liaising & support
- Gap analysis of the technical documents & quality systems
- Regulatory support for product development documents such as design history files
- Regulatory support for technical file compilation
- Regulatory and market intelligence support
- Document and labeling translation support
- Successful submissions for varied class of devices ranging from software to sutures
- Local affiliate access to meet challenges of authority and language specific requirements
- Dedicated personnel to cater Medical Device and IVD Regulatory support
- In-country or legal representation support with cost effective model
- Exclusive delivery center in India