The Medical Device Authority (MDA) has announced the release of the Sixth Edition Guidance Document " Requirement for Labelling of Medical Device” (MDA/GD/0026), which has been made available since November 21, 2022. There are two added requirements in the general content of labelling in the new edition in the clause 4.8.1:
- 1. Name, address and contact details [email and/or phone number and/or website address] of the manufacturer and AR (in the case of a foreign manufacturer, contact details [email and/or phone number and/or website address], is optional) to obtain technical assistance.
- 2. The details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device.
Harmonized worldwide labelling requirements would provide major benefits to manufacturers, users, and/or patients, as well as regulatory authorities. Eliminating or reducing differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments. For more details can refer MDA/GD/0026.
References:
Requirement for Labelling of Medical Devices