With a dual system (Public & Private) in healthcare and with the current profitable scenario of Pharma manufacturing, Hong Kong offers best deal of growth opportunities for foreign medicine and medical device manufacturers, to enter the region. While the Department of Health (DoH) takes control of drug registration and imports/exports, the Medical Device Control Office (MDCO) supervises the medical device’s regulatory requirements. Not only the stricter regulatory requirements but also the prolonged approval timeframes (18-24 months for drugs) might challenge the manufacturer’s plan for quicker time-to-market.

As a specialized global Regulatory partner, Freyr assists organizations with the expert knowledge of Hong Kong Regulatory system. Freyr’s expert and dedicated regulatory teams provide end-to-end support for preparing and reviewing registration documents, manage submissions and registrations within regulated time-frames and thereafter obtaining health authority approvals. To streamline the Regulatory processes in the region, Freyr provides advice on regulatory consultation and submission strategies for:

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Regulatory Process Optimization
  • New Product Registrations
  • Local Authorized Representation
  • Labeling updates
  • Amendments to registered product particulars
  • CE Marking

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with MDCO
  • Experienced and Expert Regulatory team
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market