CDSCO Releases Updated List of Accredited Labs for In-Vitro Diagnostic Device Testing in India
The Central Drugs Standard Control Organization (CDSCO) has released an updated list of accredited laboratories authorized to conduct performance evaluations of In-Vitro Diagnostic (IVD) medical devices across the country. This update, dated June 4, 2025, identifies a network of laboratories specializing in a wide range of diagnostic categories—from infectious diseases like HIV, Hepatitis B and C, Tuberculosis, and Malaria to non-communicable and genetic conditions such as cancer, congenital disorders, and Methicillin-Resistant Staphylococcus aureus (MRSA).
Dr. Rakesh Kumar Rishi Authorized to Sign Medical Device Test Certificates for Courts
The Central Government, under the Ministry of Health and Family Welfare, has authorized Dr. Rakesh Kumar Rishi, the Director In-charge of the Central Drugs Laboratory (CDL) in Kolkata, to sign statutory certificates of test or evaluation for medical device samples sent by Courts of Law. This notification was issued on May 16, 2025.
Government Seeks Input on Revision of Risk Classification of Cardiovascular & Neurological Medical Devices
The government has revisited the existing classification lists for Cardiovascular and Neurological medical devices and added new entries based on their classification as outlined in the First Schedule (Part I) of the MDR, 2017. To ensure a comprehensive and transparent process, the government is seeking input from all concerned associations and stakeholders by May 1, 2025.
ICMR & CDSCO Seek Input On HMPV Real-Time PCR Evaluation Protocol
The current draft focuses specifically on laboratory performance evaluation of HMPV real-time PCR kits, with all clinical samples tested according to the candidate test’s instructions for use. The primary purpose is to evaluate the performance characteristics of these kits in diagnosing HMPV infection/disease.
ICMR and CDSCO Seek Public Input on Draft Protocols For Standardizing IVD Testing
ICMR and CDSCO have developed a series of draft standard evaluation protocols for specific IVDs. These protocols outline the methodologies and criteria for testing the quality and performance of these diagnostic tools. ICMR and CDSCO are now inviting comments from all interested stakeholders on these draft protocols. This window for public input closes on February 15, 2025.
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.
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.
