Medical Device
October 25, 2023
Overview of the CDSCO License Mandate The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body that manages medical device registration in India under the Ministry of Health & Family Welfare. The main aim of CDSCO is to ensure that medical devices are...
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July 28, 2016
We are fully experienced, and have specialized skills in providing assistance to international pharma companies who want to register their products in the USA and the European Union. We are also...
Blog
July 28, 2016
Regulatory Affairs at US-FDA Drug & Medical Device Regulatory Consulting CliniExperts have aligned themselves with the internationally renowned regulatory consulting companies. These companies have a proven track record in drug, medical device, and regulatory consulting...
Blog
July 28, 2016
The items which are not restricted can be easily imported but, the ones which are restricted need to get approval from DGFT (Directorate General of Foreign Trade). We at CliniExperts provide...
Blog
July 28, 2016
Zonal Licences (East, West, North and South Zone) We employ a network of specialists who are able to assist in obtaining any of the licenses or NOC's issued by the four zonal authorities in India....
Blog
July 28, 2016
Presently, the Indian market for medical devices is largely unregulated. Medical devices are freely imported into India. Only certain products require medical device registration in India. Over the years, there have...
Blog
July 28, 2016
The clinical trial of Medical Device is different in nature as compared to that of Drugs or vaccines. In case of Medical Device, they do not conduct Phase I clinical trial to...
Blog
July 28, 2016
The Expert Committee constituted by the Ministry of Health & Family Welfare decided that if India participates in global clinical trial for NCEs to be used for diseases prevalent in our population,...
Blog
July 28, 2016
The Expert Committee constituted by the Ministry of Health & Family Welfare decided that if India participates in global clinical trial for NCEs to be used for diseases prevalent in our population,...
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