A list of recently updated articles regarding medical device regulatory updates from the CDSCO and other governing bodies in India.

India Moves to Online Application Submission System for Medical Device Registration

/in , /by

The Drugs Controller General of India (DCGI) announced on May 1, 2016 that the SUGAM online application submission system, in use since November 2015 for pharmaceutical registration, would be extended to medical device and IVD device submissions (e.g., registration and import license applications).

Read more

Increase in Independent License Holder Option in India

/in , /by

More companies are setting up a subsidiary or using an independent license holder in order navigate the highly rationalized Indian market.

Read more

Ablation Devices Now Require Registration in India

/in , /by

The India Ministry of Health and Family Welfare added ablation devices to the list of notified medical device that require registration.

Read more

New Office Space for Asia Actual India

/in , /by

Asia Actual is excited to announce the dedication of our new office space in the Delhi area.  

Read more

INDIAN GOVERNMENT REMINDS MEDICAL DEVICE INDUSTRY OF PENDING REGULATORY CHANGES

/in , /by

Exactly 6 months before the new Medical Device Rules, 2017 are to take effect the Drugs Controller General (India), Dr. G.N. Singh, published a notice that serves as a reminder to industry to prepare for the coming changes.

Read more

INDIA APPLIES PRICE CONTROLS TO KNEE PROSTHESES

/in , /by

Yesterday, India’s National Pharmaceutical Pricing Authority (NPPA) implemented price controls for knee prostheses resulting with an average reduction of 65% from prevailing market prices. The announcement was published on August 16, 2017, with immediate effect (full document available on the India page of Asia Actual’s website).

Read more