Commercialisation is in sight for Glucosenz as it prepares for final submission to the Medical Device Authority (MDA), as well as the application for ISO 13485 standard and CE Marking—certifications that are needed for Glucosenz to be marketed as a medical device.
Medical Device Authority (MDA)
Under MDA regulations, all medical devices marketed in Malaysia need to be registered either by Local Manufacturers or a Local Authorized Representative for overseas manufacturer. With the excellent results obtained from its clinical testing, Glucosenz is anticipating for the authorisation to market its medical device very soon. Glucosenz is currently collaborating with the Bioengineering University Malaya Malaysia to register our product with the MDA.
As Manufacturer of Glucosenz, we are required to have ISO 13485 certification to showcase our commitment and capability in meeting requirements and maintaining a high standard.
The ISO 13485 certification also allows organisations to demonstrate their capacity to provide medical devices and related services that are consistently meeting the needs of consumers, while also abiding government and regulatory requirements.
Glucosenz has also undergone an audit to include a new scope of focus, a “Design and Development, Manufacture and Distribution of Optical Non-Intrusive Blood Glucose Detector” in the current ISO 13485:2016. This new certificate with the new scope will be received within 3 weeks.
CE Marking is the manufacturer’s claim that their products meet the essential requirements of all relevant European Medical Device Directives, and outline the safety and performance requirements for medical devices in the European Union (EU). The CE mark is also a legal requirement before a product can be placed in the EU market.
To date, we have fulfilled the first three items in the checklist for CE Marking: developing technical file; identifying and performing the required testing; and conducting clinical trials along with sharing the result and conclusion.
Glucosenz is approaching the final step to provide a better future for all who suffer from diabetes, and a brighter one for those at risk.