Tag Archive for: post-approval changes

MDD Issues Guidance on Making Changes to Medical Device Licenses in Hong Kong

On November 30th, the Hong Kong Medical Device Division (MDD) issued formal guidance on the requirements to make changes to medical device licenses registered in the Medical Device Administrative Control System (MDACS).

INDIA COMPLIANCE MAINTENANCE: NOTIFIED BODY CHANGE

Given recent conditions of Brexit, many companies are impacted with changes regarding their notified body. This change ultimately changes the CE Mark on labeling, thus requiring amendments to any existing Import Licenses in India.