A list of recently updated articles regarding medical device regulatory updates from the CDSCO and other governing bodies in India.
India’s Pollution Control Board (CPCB) has issued an update on plastic packaging and Plastic Waste Management (PWM) requiring importers quantify the type of plastics being imported through a brief registration process.
In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
India’s CDSCO has issued important guidance on the process for medical device Import License renewal. This process is newly coming into effect, as the first round of Import Licenses issued under the new Rules will start to expire this year.
As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”
As of April 27th, India’s CDSCO will allow COVID test kits with the following approvals to bypass in-country validation testing. Previously only tests approved by the USFDA (including Emergency Use Authorization) were exempt
After the voluntary period ends on October 2021, all class A and B non-regulatory medical devices will have 12 months (i.e., by October 1st, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1st, 2023) to meet the same requirement.
On March 25, 2021, a notification was released specifying 19 more devices belonging to categories such as gloves, syringes, orthopedic products, x-ray machines, etc. that only local manufacturers could bid on.
With the release of a new order on Nov 3, 2021, CDSCO has postponed the Import Licensing requirement for 8 categories of medical devices.
The updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.
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