What is CDSCO Class C Medical Device Registration? If you manufacture, import, or plan to sell CDSCO Registration For Class C medical devices in India, you already know the stakes. Class C sits in the third tier of India’s four-tier medical device risk classification — above the low-risk Class A [...]
Introduction The BIS FMCS Portal Online is Manakonline.in, the official digital platform of the Bureau of Indian Standards (BIS) for the Foreign Manufacturers Certification Scheme (FMCS). Starting 1 June 2026, BIS made online submission compulsory for every FMCS application, ending the earlier paper-based system that required physical document dispatch to [...]
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 [...]
To legally manufacture or import soap and body wash products in India, you need a cosmetic license under the Drugs & Cosmetics Act, 1940. What Is a Cosmetic License for Soap and Body Wash Products? In India, soap and body wash products are classified as cosmetics under the Drugs & [...]
What is CDSCO License for Dermatology and Plastic Surgery? CDSCO (Central Drugs Standard Control Organization) registration is the mandatory government approval process for all medical devices sold in India. For dermatology and plastic surgery devices, every manufacturer or importer must register their product under the Medical Devices Rules, 2017. Devices [...]
CDSCO registration for SaMD in India is mandatory for all Software as a Medical Device products under the Medical Devices Rules (IMDR) 2017. SaMD is classified into Class A (low risk), B (low-moderate), C (moderate-high), and D (high risk). The registration process requires filing with the Central Drugs Standard Control [...]
CDSCO registration for dental medical devices is mandatory under India’s Medical Device Rules (MDR), 2017. All dental devices — from basic instruments to complex implants — must be licensed before manufacture, import, or sale in India. CDSCO classifies dental devices into Class A (low risk), Class B (low-moderate risk), Class [...]
To legally manufacture or import sunscreen in India in 2026, you need a cosmetic license under the Drugs and Cosmetics Act, 1940. Importers must apply using Form COS-1 and receive Form COS-2 (import license) from CDSCO. Manufacturers must apply using Form COS-5 and receive Form COS-8 (manufacturing license) from the [...]
