REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA
Journal Title: International Journal of Drug Regulatory Affairs - Year 2018, Vol 6, Issue 1
Abstract
India is a huge market for medical devices and is increasing constantly for the last few years. The registration certificate and import license is mandatory for a manufacturer of India who wishes to import any medical device in India. If a company which wants to imports its medical devices in India does not have a registered office in India it needs Indian agent authorized by CDSCO, to do so. Duly filled form-10 is required to be submitted for import license, while form-44 duly filled is required to be submitted for marketing authorization of a new medical device or its reregistration. The review focuses on regulation concerned to the registration procedures import of a new medical device in India with latest amendments in the regulation concerned. Keywords
Authors and Affiliations
Vikaas Budhwaar, Yogesh 1Rohilla, Manjusha Choudhary, Prateek kumar
DMF FILING IN US, EUROPE AND CANADA
A Drug Master File or DMF is a reference source that provides drug evaluator’s confidential information not available to drug product manufacturer about the specific process and components used in the manufacturing, proc...
COMPLEX GENERICS: OPPORTUNITIES & CHALLENGES
Now a day, big pharmaceutical companies with sustainable revenues are more interested in complex products to minimize competitions. In line with the originator companies, many generic companies are also focusing on compl...
LIPOSOME AS A DRUG DELIVERY CARRIER-A REVIEW
The evolution of the science and technology of liposomes as a drug carrier has passed through a number of distinct phases. Because they exhibit peculiar properties due to their structure, chemical composition amphiphilic...
PROBIOTIC FUNCTIONAL FOOD VS DRUGS: IMPACT OF INDIAN REGULATORY STATUS ON DESIGN OF QUALITY CONTROL GUIDLINES FOR PROBIOTICS
Probiotic now a day's generally utilized all around the globe because of headway as a part of the relationship in the middle of nourishment and wellbeing other than their promising helpful advantages and irrelevant react...
Integrating PLCM strategy in Pharmaceutical Emerging Market
All products and services must denote definite life cycles. The life cycle talks about the period from the product‘s first launch till it wind-up onto the market. Throughout this age noteworthy modifications are made in...