Industry update

admin

Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) as Certification Body for ICMED 9000 and ICMED 13485 Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) is awarded provisional approval from the Quality Council of India (QCI) to function… 

CDSCO mandates online safety reporting

admin

CDSCO mandates online safety reporting for Medical Devices Following pharmaceuticals, the Central Drugs Standard Control Organisation (CDSCO) has mandated that manufacturers of medical devices and in-vitro devices submit their safety reports online. The Drugs Controller General of India, has issued… 

Regulatory Guidelines for Sampling of Drugs

admin

REGULATORY GUIDELINES FOR SAMPLING OF DRUGS, COSMETICS & MEDICAL DEVICES BY DRUGS INSPECTORS OF CENTRAL & STATE DRUG AUTHORITIES Drugs Inspectors of Central & State Drug Authorities have released the guidance document for sampling of drugs, cosmetics & medical devices… 

Industry Update – Program by KIHT

admin

International Fellowship on Health technology assessment byKIHT, Visakhapatnam The 9th International Fellowship on Health technology assessment is being launched by Kalam Institute of Health Technology, Visakhapatnam, to promote the advancement of knowledge and expertise in health technology assessments. KIHT aims to equip… 

Industry Update – QMSR for Medical Devices

admin

Quality Management System Regulation (QMSR) for Medical Devices The Quality Management System Regulation (QMSR) for Medical Devices, released by the FDA on January 31, 2024, is a significant update to the existing Quality System (QS) regulation (21 CFR Part 820).…