Global market access is crucial for medical device companies looking to reach new customers, enhance brand recognition worldwide and ultimately increase revenue opportunities. However, expanding operations and reaching new countries can be highly challenging for these...
The article provides a general overview of the existing legal framework for advertising healthcare products allowed for marketing and use in Singapore.
The new article describes in detail the key aspects related to the advertising activities in the context of medical devices intended to be marketed in Singapore.
The new article provides additional details regarding the subsequent steps of the recall process, including the development of an action strategy, drafting a communication strategy to be followed when conducting a recall, and also the matters related to interactions with the authority, such as the noes associated with the submission of the relevant notification and an assessment to be conducted by the TGA
The article provides a comprehensive overview of the requirements to be followed by a party responsible for a recall when preparing and issuing a sponsor’s customer letter to ensure all the critical safety-related information is appropriately communicated to the addresses.