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Registration

In India, medical devices and drugs are required to be registered with the CDSCO (Central Drugs Standards Control Organization, headquartered at New Delhi) prior launch. Though products with US FDA approval and CE compliance are easier to register, the whole process typically takes between seven to ten months. In case of certain new drugs and products (eg special utility disposables) which do not have the US FDA or CE endorsement, CDSCO may make it mandatory to undertake Clinical Trials prior launch of the product or drug in India.

Our team of experts includes health care professionals, regulatory compliance consultants and doctors. We focus on guiding you through our regulatory compliance consultancy service while providing full service package “One stop shop” to you in order to speed-up the process from product development to market clearance. From the implementation of QMS, product validation, sterilization, realization of clinical trials to obtaining Registration Certificate and Import Licence process step by step.

Admirus prides itself on its strong network and liaison with Government functionaries, which coupled with our knowledge of Indian laws, enable us to negotiate hurdles in the regulatory process efficiently and reduce this downtime considerably.

Nevertheless, in view of the long lead time required to get the product registration certificate, we would encourage you to start this process as soon as you have made the go/ no-go decision. Once the registration is complete, you are ready to embark on your next step – that of appointing a distributor who will start importing your product and selling it in India.

Whether you are marketing pharmaceuticals/drugs or medical devices, equipment, instruments, supplies, count on Admirus to move you forward in the registration and approval process.