Medical Device

On the 20th of November 2023, the Central Pollution Control Board (CPCB) issued a directive alert, extending the deadline for filing the Annual Report for FY 2022-23 on the Centralised Extended Producers Responsibility (EPR) Portal for Plastic Packaging. The new deadline for compliance is set on or before the 30th of November 2023. Understanding Plastic […]

Introduction Obstetrics and Gynaecology, often referred to as OB-GYN, encompass medical care related to pregnancy, childbirth, and female reproductive health. The regulatory framework in India for medical devices in this field is overseen by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act of 1940. This article outlines the CDSCO registration

Unraveling the Medical Device Classification Let’s dive into the intricacies of CDSCO medical device classification in India. The Central Government set the stage in 2017 with a set of rules outlining different classes for these devices. However, the clarity on which device fits where was as clear as mud. The term ‘Class’ became a crucial

Guidelines for Non-Notified Medical Device Manufacturing License / New Medical Device Registration in India Including classification, licensing authority, required documents, regulatory compliance, and timeline.

CDSCO is the Authority regulating the grant of permission to manufacture / import license for new medical devices in India.
The manufacturing/import license is the mandatory requirement for selling and distributing new medical devices that do not have a predicate medical device in India.
Form MD 26 is the application form to be submitted to Central Licensing Authority (CLA)for approval, and CDSCO will issue the permission license in Form MD 27.
The timeline for obtaining new medical devices is between 2 to 3 months.
The Government charges a prerequisite fee of 50000 INR for obtaining this license.