Unlocking Excellence: Laboratory Accreditation and ISO 17025 Compliance for Reliable Testing and Calibration

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 …

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 …

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 …

Labeling of Medical Devices from the standpoint of GMP / QMS

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.

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.

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