Tag Archive for: hong kong

Hong Kong Refines Medical Device Post-Market Surveillance Report Form

On December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form.

HONG KONG EXTENDS PILOT PROGRAM TO RECOGNIZE CHINA AND KOREA AS REFERENCE COUNTRIES

By allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.

Voluntary Medical Device Registration in Hong Kong

Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.