Overview

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:

• Medical Devices
• Pharmaceuticals
• OTC
• Food and Food Supplements
• Cosmetics - Cosmetics Product Registration Procedure
• Biosimilar