The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices and serves a parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.[The government has announced its plan to bring all medical devices, including implants and contraceptives, under the view of the Central Drugs and Standard Control Organisation (CDSCO) But Some instruments, Equipment with IVD will not cover in Medical Device rule Such as hemoglobinometer based micro cuvette technology which is reagent free because Micro cuvette is under the category of plastic disposable which is only used for sample collection and this category is not regulated under the provision of Class II of IVD Medical device rules.
Yes, for test examination and analysis at other firm premises a notarized agreement between them and manufacturing Licence or DSIR approval of other firm premises has to submit .
Only 10 drugs can be imported under single Form11 licence.
As per Rule 33 of Drugs and Cosmetics Acts and Rules Form 11 is granted for the import of small quantities of drugs for the purposes of examination testing or analysis.
There is no provision for the renewal of Form 11 licence once it is expired the firm has to apply for fresh form11 licence with challan all other relevant documents.