As mentioned in our September newsletter, starting this year India’s CDSCO has issued new draft rules for its device classification catalog. Medical devices are classified at both the State and National level depending on their risk profile. Higher-risk devices (Class C and D) are classified at the National level while lower-risk devices (Class A and B) are classified at the State level. In the past, this often led to misclassification and delays in registration. Also, classifications from one State could vary from the classification in a different State. The goal of the new classification catalog, once implemented, will be to reduce uncertainties and expedite device registration.
In addition to the above, on January 6 the CDSCO added new medical device categories to existing classifications – including interventional radiology (186 new categories), Radiotherapy (114 new categories), Oncology (75 new categories), and Class A (non-sterile and non-measuring medical devices (803 new categories). Feedback to the Indian CDSCO on these draft lists can be done through the google form within 30 days.
In an effort to expedite drug registrations, India has also stated that new drugs already approved in the US, Japan, Australia, Canada, the UK, and the EU will not need to perform clinical trials in India. New drugs refer to orphan drugs, drugs with significant advantages over already approved drugs, drugs needed for defense purposes, etc. However, it is not clear how the definition of – significant advantages – over already approved drugs is defined. Also, on April 1, India will implement mandatory registration requirements for CROs. Besides stricter rules on the qualifications of CROs, on-site audits may occur.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.