Medical Device Regulatory Alert
Under the Medical Device Rules (MDR) 2017, all medical devices and In-Vitro Diagnostic (IVD) kits marketed in India are categorized risk-wise into Class A, B, C, and D. With the culmination of transition windows, Class C and D devices (moderate-high and high risk) mandate an active MD-14 Import License issued by the Central Licensing Authority (CLA).
Key Requirements for MD-14 Import License
Foreign manufacturers cannot directly file an application; they must legally designate an Authorized Indian Agent (AIA) who holds a valid wholesale drug license (Form 20B/21B).
- Plant Master File (PMF) & Device Master File (DMF): Comprehensive dossier adhering to ASEAN Common Submission Dossier Template (CSDT).
- Free Sale Certificate (FSC): From national regulatory authority (US FDA 510k/PMA, CE Mark under EU MDR, Japan PMDA).
- ISO 13485:2016 Certification: For manufacturing site quality management.
