What Is CDSCO Registration for Intraocular Lens? CDSCO registration for Intraocular Lens is the regulatory clearance issued by the Central Drugs Standard Control Organization (CDSCO), India’s national medical device regulator under the Ministry of Health and Family Welfare, before an IOL can legally be imported, distributed, or manufactured in India. [...]
What is BIS CRS Registration for Tablets? BIS CRS Registration for Tablets is mandatory certification under the Electronics and Information Technology Goods (Requirement of Compulsory Registration) Order, 2021. Every tablet sold or imported in India must carry a valid BIS Registration Certificate issued under Scheme II. The applicable safety standard [...]
Introduction CDSCO registration for surgical mask in India follows three role-based pathways, since surgical masks are classified as Class A (low-risk) devices under the Medical Devices Rules, 2017. Manufacturers apply on Form MD-3 and are granted a manufacturing license on Form MD-5 by the State Licensing Authority. Importers apply on [...]
Introduction RF testing for GPS trackers and IoT sensors is the mandatory radio-frequency evaluation that checks a device’s operating frequency, output power, bandwidth, and spurious emissions against India’s wireless regulations. Any GPS tracker or IoT sensor with a transmitting module — GSM, LTE, Wi-Fi, Bluetooth, Zigbee, LoRa, or NB-IoT — [...]
Introduction BIS CRS (Compulsory Registration Scheme) registration is mandatory for all LED Televisions sold in India under the Electronics and Information Technology Goods (Requirement of Compulsory Registration) Order, 2021. The applicable standard is now IS/IEC 62368-1:2023 (migrating from IS 616:2017), with concurrent running until 1 November 2028. As of 25 [...]
Introduction Any business that manufactures or imports shampoo in India must obtain a CDSCO cosmetic license under the Drugs & Cosmetics Act, 1940 and Cosmetics Rules, 2020. Manufacturers apply via Form COS-1 (new license) or COS-5 (adding variants) and receive their license on Form COS-8. Importers apply via Form COS-2 [...]
Introduction CDSCO Registration for BP Monitor is mandatory under India’s Medical Device Rules, 2017, before any blood pressure monitor — manual, digital, or ambulatory — can be manufactured, imported, sold, or distributed in the country. CDSCO classifies the BP monitor as a Class B (low-to-moderate risk) medical device, so it [...]
Introduction CDSCO X-Ray Machine Registration in India is mandatory under the Medical Devices Rules (MDR) 2017. X-ray machines are classified as Class A, B, C, or D medical devices depending on risk level. Importers must obtain MD-14 (application) and MD-15 (import license). Manufacturers need MD-3/MD-5 for Class A/B or MD-7/MD-9 [...]
Introduction CDSCO Korean face serum registration in India follows two paths. For importing Korean-made serums, you submit a COS-1 application and receive COS-2 Grant of Import License. For manufacturing Korean-formulated serums in India, you apply via COS-5 and receive COS-8 Grant of Manufacture License. Both processes require product safety data, [...]
Introduction CDSCO medical device registration for surgical instruments is the mandatory approval process under the Medical Devices Rules, 2017, that lets a business manufacture, import or sell surgical instruments in India. Instruments are classified as Class A (low risk), B (low-moderate), C (moderate-high) or D (high risk) based on intended [...]
