What is the difference between US FDA 510(k) and PMA? A Guide
All medical devices entering the US market must comply with the regulatory requirements formulated by US FDA. These regulatory requirements are in place to ensure safe, effective, and high-quality medical devices reach the patients. The regulatory pathway required...
10 Tips for Outsourcing Regulatory Affairs Team
Outsourcing is becoming increasingly common in pharmaceutical, medical device, and biotechnology, industries, especially in regulatory affairs and pharmacovigilance domains. Large and small companies alike are now turning to outsourcing vendors to manage...
Get CDSCO License for Surgical Instruments for General Use
As general use surgical instruments are intended for general surgical procedures, they have to be strictly regulated. The Central Drugs Standard Control Organization (CDSCO) is at the helm of medical device regulation in India. It aims to protect public health,...