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 Medical Devices (Amendment) Rules, 2020, was effective from 01st April 2020. Introduction of a new chapter namely, Chapter IIIA, which deals with the registration of medical devices, and the modification of Eight Schedule, were the major amendments made to the existing rules. A major modification in the definition of the Medical devices was also …
On 11th February, 2020, the Ministry of Health and Family Welfare, Govt. of India published a gazette notification namely S.O. 648(E), which puts the definition of medical devices on par with the definitions of rest of the world. This notification is effective from 01st April 2020. You can go through the earlier definition here. In …
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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