What Is CE Marking for IVD Devices? CE marking on an in vitro diagnostic device is the manufacturer’s declaration that the product meets all applicable European Union health, safety, and performance requirements. The ‘CE’ stands for Conformité Européenne — French for European Conformity. If your device tests samples taken from [...]
What is CDSCO Class B Medical Device Registration? If you manufacture, import, or plan to sell Class B medical devices in India, you already know the stakes. Class B sits in the middle of India’s four-tier medical device risk classification — above the low-risk Class A and below the high-risk [...]
BIS CRS (Compulsory Registration Scheme) registration is mandatory under the QCO for all LED luminaires sold or imported into India under IS 10322. Manufacturers and importers (including Chinese OEMs) must test products at a BIS-recognized lab, apply via the BIS SATHI portal, and obtain a CRS license before sale. As [...]
