List of Newly Notified Medical Devices That Requires Registration

1. List of Newly Notified Medical Devices That Requires Registration With the advancement of technology and enhanced scientific development, the involvement of research in medical devices has increased ten folds resulting in an increase in device production and usage. This requires new and improved regulations to maintain the right quality and avoid the inflow of duplicate products into the market. As per CDSCO, a medical device is a device that is intended for getting used in diagnosis, mitigation, prevention and treatment of disease in human beings. CDSCO is responsible for the registration of medical devices as well as regulations of new drugs and clinical trials in the country. Medical devices have been classified into four categories in a list based upon the level of risk associated with their use. Namely Class A, Class B, Class C and Class D. Class A devices are associated with the least risk and Class D devices with the highest. Recently some newly notified medical devices have been added to this list under class B and C as per the latest amendment in May 2019. These devices include: Newly Notified Class C Devices: ● CT Scan Equipment ● MRI Equipment ● Defibrillators ● Dialysis Machine ● PET Equipment ● X-Ray Machine ● Nebulizer ● Glucometer Contact No: +91 7672005050 Email: contact@cliniexperts.com

2. ● Newly Notified Class B Devices: ● Bone Marrow Cell Separator ● B.P Monitoring Devices ● Digital Thermometer Medical device registration In India involves six steps out of which the first step is to determine whether the device requires registration or not. Only some notified devices fall under the regulations that are specified in the Drugs & Cosmetics Act 1940. The registration process starts with the applicant submitting the details and supporting documents with a properly filled form. The product information is then properly examined by CDSCO, and a written statement is issued about the regulatory status of the products. The whole process takes about 4-12 weeks. If the product is not registered in countries like USA, Europe, Australia, Japan or Canada, the applicant is required to prove the efficacy of the medical device by the conductance of clinical trials for further investigation. At present, there are about 22 types of medical devices that require a registration under this act. These include: ● Disposable Hypodermic Syringes ● Disposable Perfusion Sets ● In-vitro Diagnostic Devices for HIV ● HbsAg, Cardiac Stents ● Drug-Eluting Stents ● Catheters ● Intraocular Lenses ● I.V. Cannulae ● Bone Cement ● Heart Valves Scalp Vein Set Organ Preservative Solution Contact No: +91 7672005050 Email: contact@cliniexperts.com

3. ● ● ● ● The Medical Device Regulation India process can be somewhat tedious and hectic. Therefore, it is recommended for all manufacturers who are not sure about the status of the regulations for their product to take the help of a licensed medical device consultant. Orthopaedic Implants Internal Prosthetic Replacements Spinal needles Orthopaedic Implants Contact No: +91 7672005050 Email: contact@cliniexperts.com