India’s CDSCO Expected to Begin Enforcing Local BIS Standards

On 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.

Indian Industry Association Drafting a Uniform Code for Medical Device Marketing Practices

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.

India’s CDSCO Updates Classification of Several Product Categories

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.

India Launches Scheme for Promotion of Medical Device Parks

The scheme for “Promotion of Medical Device Parks” is a key initiative to support the medical devices industry with with a financial outlay of Rs. 400 crore (~US$51 million).

India Establishes Committees to Streamline Regulatory Framework and Address Denovo Products

The Indian government has established 2 committees to help streamline the regulatory framework and establish denovo guidance.

India’s CDSCO Adds United Kingdom to List of Accepted Reference Countries

On 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.

India’s MOH Releases Draft Amendment to the Medical Device Rules 2017

On 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.

India Announces New Notified Medical Devices Now Requiring Import Licenses

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.

India’s CDSCO Releases Draft Notice for Suspending or Cancelling Import Licenses

Prior to this draft notification, there was no explicit rule providing clarity about the cancellation or suspension regarding the import License in case of any violation of the conditions by the license holder while such provisions were included for a manufacturing license in the MDR 2017.

India’s Public Hospitals Advised to Purchase Local Products

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.