Medical Devices and In-vitro Diagnostics (IVD)are regulated in India through the Medical Device Rules, 2017. The authority which regulates medical device and In-Vitro Diagnostics (IVD) in India is the Central Drugs Standard Control Organisation (CDSCO), which is headed by the Drug Controller General of India (DCGI). The approval with respect to medical device is granted by the Central Licensing Authority (CDSCO) and the State Licensing Authority (SLA), depending upon the class of the medical dev...
The regulation of Drugs in India, with respect to manufacturing and importing of drugs is primarily governed by the Drugs and Cosmetic Act and Rules ,New Drug and Clinical Trials Rules 2019 and various other regulations that are issued by the Government from time to time. These regulations are implemented in India by a 3 tier system, i.e., the Central Drug Standard and Control Organisation(CDSCO), the Zonal offices of CDSCO and the State FDA. We, at CoreLEX, help the manufacturers an...
In India, the CDSCO regulates and controls the import of Beauty and Personal Care Products under the Drugs and Cosmetics Act and Cosmetics Rules 2020. We offer our clients complete assistance,planning and review of the various processes of import of cosmetics or import of new cosmetics or import of cosmetics already registered in India. Our experts have many years of experience in carrying out cosmetics import and registration,certification and manufacturing permission thereby, making us yo...
Food product is regulated in India though Food Safety and Standards Act 2006. The Food Safety and Standards Authority of India (FSSAI) has been established under Food Safety and Standards 2006 which consolidates various acts & orders that have hitherto handled food related issues in various Ministries and Departments. FSSAI has created for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability ...
CoreLEX Solutions Private Limited, comprises of experienced regulatory affairs professionals, who provide complete guidance and support to pharmaceuticals, medical devices, vaccines, foods and cosmetics companies in making and execution of blueprint of regulatory strategies. Our services include assistance to organizations in expediting their product development and registration of drugs (medicines), biological (vaccines), medical devices& IVDs, cosmetics, foods items, nutraceuticals, health supplements and other healthcare products for all phases of development.
Our services include:
Our team is highly flexible and can team up with clients in a way that suits the client’s needs, either as a lead role on the project, or simply provide complete guidance and assistance to your existing regulatory staff as required with thoughtful and well-researched strategic input.
If you need information on our services or have a query, get in touch with us.
Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. They are regulated at EU Member State level, but the E...
