Good Manufacturing Practice in Indian context
Pharmaceutical Regulations in India
The permission to conduct clinical performance evaluation for new in vitro diagnostic medical device can be obtained by a sponsor on submitting an application in Form MD-24 to the Central Licensing Authority, along with a fee prescribed in the Second Schedule and the required documents. If the application complies with the statutory requirements, then the …
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The procedure to obtain permission to conduct clinical investigation of investigational medical device and the conditions to be complied with.
The labeling of the medical devices are discussed from the stand point of Good Manufacturing Practices and Quality Management system. It describes about the label content development and label control.
Labeling of medical devices as mentioned in the medical devices rules 2017 for provided in a concise manner along with a little bit of descriptions and explanations.
This blog post explains the import of medical devices for test, evaluations, clinical investigations. Import of investigational medical device by Government Hospital, import of medical device for personal use etc.
This blog post explains the conditions to be followed after obtaining the import licence and the time limit for the application of change in constitution.
This blog explains the procedure to be followed for obtaining the import licence of medical device and the validity of such licence.
The application for the manufacturing of small quantities of Class A or Class B or Class C or Class D of medical devices for the purpose of clinical investigations, test, evaluation, examination, demonstration or training shall be made in Form MD-12 to the Central Licensing Authority along with a fee as specified in the Second …
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The manufacturing or testing activity should be performed only under the supervision of the competent technical staff and at least one unit of sample from each batch of invasive medical device and in vitro diagnostic medical device should be maintained for 180 days after the expiry date. If applicable the medical device should be accompanied …
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Any person who intends to manufacture Class A or Class B medical device including the in vitro diagnostic medical device must apply to the state licensing authority through the online portal of Central Government in Form MD-3 (for licence) or MD-4 (loan licence) along with the required fees as specified in the second schedule and documents as specified in Part-II of the fourth schedule. The application should also accompanied by an undertaking that it complies with the Quality Management System, as specified in the Fifth Schedule