Blog

In India import, manufacturing, sale and distribution of medical devices is regulated as Indian MEDICAL DEVICES RULES 2017, under Drug & cosmetic act. Two authorities are responsible for issuing certification- CDSCO (for class C & D products) and the State licencing authority (For class A & B products). Process: 1.1 Classification of medical devices as per IMDR. 1.2 Implement QMS System. 1.3 Compliance to statutory & Regulatory requirements. 1.4 Technical files for Products. 1.5 Audit carried out by licensing authority (Notified Body). 1.6 Certification Documents required for registration of medical devices in India