This is the first of the series of posts regarding the ISO 17025 and accreditation. ISO 17025 specifies the management and technical requirement to be met by testing and calibration laboratories. Accreditation of the laboratories is usually performed by national accreditation bodies which usually has Mutual Recognition Agreements between other national bodies. The accreditation will …
Category Archives: medical device
Clinical Performance Evaluation for new In Vitro Diagnostic Medical Device
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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Clinical Study of Medical Devices
The procedure to obtain permission to conduct clinical investigation of investigational medical device and the conditions to be complied with.
Medical Devices (Amendment) Rules, 2020
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 …
Medical Device – Modified Definition
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 …
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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