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.
Monthly Archives: March 2020
Labeling of medical devices – Medical Devices Rules 2017
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.
Import of Medical Devices for Test or Clinical Investigations
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.
Conditions for Import of Medical Devices
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.
Import Licence – Medical Devices
This blog explains the procedure to be followed for obtaining the import licence of medical device and the validity of such licence.
Test Licence for Manufacturing Medical Devices
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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Conditions for manufacturing or loan licence
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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