The Asia Pacific (APAC) Medical Device market is proving to be very promising for device manufacturers amidst prevalent market conditions in comparison to existing traditional markets. APAC has some of the stringent Regulatory agencies, such as, the National Medical Products Administration (NMPA), China; 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 (HSA), Singapore. Though the region stands as 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 for Medical Devices. Freyr simplifies your task of obtaining market authorizations and approvals as well as market devices in this emerging market.
- Product Classification and Registration services
- QMS Compliance strategy
- Local representation services
- Health Agency liaising & support
- Gap Analysis of 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
Strategic and well-versed local Regulatory knowledgebase – with MFDS
Team with 25+ years of strong foothold in the region
Proven track record for device registrations and submissions
End-to-end Regulatory consultation
Structured and cost-effective approach to ensure speed to market