CDSCO Issues Reminder For Payment Of Medical Device License Renewal Fees
The circular states that licenses for manufacturing or importing medical devices, and registration certificates for quality management system (QMS) audits and medical device testing labs, are issued indefinitely however, all stakeholders should ensure timely payment of the necessary fees to the designated government account before the deadline to maintain product market continuity.
Revision In Ceiling Prices Of Coronary Stents
The new ceiling prices are Rs. 10,509.79 per unit for Bare Metal Stents and Rs. 38,267.18 per unit for Drug Eluting Stents (DES). These prices are exclusive of Goods and Services Tax (GST). Manufacturers can revise their existing MRP (Maximum Retail Price) based on the new ceiling price and WPI increase.
India Strengthens International Cooperation in Medical Product Regulation
The Union Cabinet has been apprised of Memorandums of Intent (MoIs) and Understanding (MoUs) signed between the Central Drugs Standard Control Organization (CDSCO) and regulatory bodies from the Netherlands, the Dominican Republic and the Republic of Ecuador. These agreements focus on cooperation in the field of Medical Products Regulation.
CDSCO Launches National Single Window System Portal
This portal has been designed to build a system that functions as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business. The NSWS Portal for CDSCO will be independent of the SUGAM Portal or the cdscomdonline portal.
Drug Alert List for November 2023
A total of 1197 samples were tested by the CDSCO. Based on the samples tested, CDSCO has found a total of 64 drugs, medical devices and cosmetics that are identified as being deficient.
CDSCO classifies In-Vitro Diagnostic Medical Devices under Medical Device Rules, 2017
This classification has been undertaken on the basis of intended use, risk associated with the device and other parameters. CDSCO has updated its List of In-Vitro Diagnostic Medical Devices (IVD Analyzers) and List of In-Vitro Diagnostic Medical Devices (IVD Instruments). It has also added List of In-Vitro Diagnostic Medical Devices (IVD- Specimen receptacle) and List of In-Vitro Diagnostic Medical Devices under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017.
CDSCO permits applicants of Class C & D Medical Device Licences to continue Operations
The Central Drugs Standard Control Organisation (CDSCO) has issued a circular clarifying that an existing manufacturer or importer of Class C or Class D medical devices can continue to import/ manufacture these devices till 12th April, 2024. This circular has been issued with the view to limit the disruption to business continuity.
CDSCO publishes List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious for May 2023
This list includes a total of 28 drugs, medical devices and cosmetics that are identified as being deficient. Out of these 28 samples, 27 were declared as not of standard quality and 1 was declared spurious.
Medical Devices (Amendment) Rules, 2023
These Rules aim to enhance the regulatory framework governing medical devices in the country. They provide for the establishment and designation of State Medical Devices Testing Laboratories, further empowering the testing and evaluation of medical devices.
