Congrats to Singclean on getting the MDR certificate of Viscoelastic Solution for Ophthalmic Surgery! It is supposed to be the first MDR certificate of OVD in China. Thank you, our strong regulatory affairs (RA) team for all your hard work!
Since May 26, 2021, the CE certification of medical devices has officially entered the MDR era from MDD.
The new MDR places more stringent requirements on medical device companies. For Chinese exporters of medical products, the cost increases, the certification cycles lengthen and the compliance risks increase.
The MDR is four times the size of the MDD and has an emphasis on device safety. Medical device manufacturers need to update clinical data, technical documentation, and labeling for all devices and make sure the device is designed, manufactured, and tracked in accordance with the MDR’s requirements. It is never an easy things to get the MDR. However, due to the hard working of regulatory affairs (RA) team, Singclean get the MDR of OVD successfully.
Here is brief of Singclean OVD: it is a colorless and transparent gel, composed of highly purified sodium hyaluronate dissolved in buffered saline. It works as a surgical aid in ophthalmic anterior and posterior segment surgery including: Cataract extraction, Corneal transparent, Glaucoma, Filtering and Secondary lens implantation.
