Get Manufacturing And Product Development Support for Medical Devices / IVDs for Class C and Class D by CliniExperts’ professionals including product development, facility designing, documentation, quality management, manufacturing license, and audit and inspection support.
The medical device industry of India is a crucial and integral part of the Indian healthcare industry. It provides preventative, diagnostic, therapeutic, and managerial services for the treatment and management of chronic diseases, various medical conditions, illnesses, and disabilities.
A medical device is one of the major pillars of healthcare delivery systems together with healthcare providers, pharmaceutical companies, and insurance industries. So that all citizens will be able to get affordable, high-quality, and comprehensive healthcare by National Health Policy (NHP) 2017.
To accelerate the growth of the medical device sector, an approach paper has been drafted to facilitate orderly growth and get a clear direction aimed at facilitating objectives of safety standards, quality, affordability, and accessibility, while maintaining the emphasis on innovation, and sustainability.
Class C classifications have moderate to high-risk medical devices / IVDs while Class D classifications have high-risk medical devices / IVDs. Class C and Class D medical devices / IVDs are regulated by Central Licensing Authority (CLA) or Central Drugs Standard Control Organisation (CDSCO). If you want to manufacture or import class C or class D medical devices, you need to get a license from the regulated authority.
sr. No | Medical Device Name | Intended Use | Risk Class |
1 | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals | This device is an application with a graphical user interface. It is designed to calculate insulin requirements (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) depending on data from external devices such as continuous glucose monitors. | C |
2 | Dental Abutment Design Software For Dental Laboratory | This medical device is used to help in the remodeling of chewing function by permitting a dental laboratory to create a patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM. | C |
3 | Thoracic electrical impedance tomography system | A group of medical devices is created to take continuous bio-impedance measurements throughout a cross-section of the thorax, to give real-time feedback on the lung function of a ventilated patient. | C |
4 | Therapeutic positive pressure breathing ventilator | A medical device utilized for therapeutic rehabilitation of patients with chronic respiratory diseases, and circulation of aerosolized pharmacological agents to the patient’s airways and lungs. | C |
5 | Eye valve | An implantable device regulates the flow of fluid between the anterior chamber and space around the conjunctiva of an eye by permitting flow when the pressure in the chamber is above pre-set value. | C |
6 | Aqueous/vitreous humour replacement medium kit | A group of sterile devices, consisting of fluid or semifluid substances, is utilized in combination to supplant the fluid of the eye. | D |
7 | Behind-the-ear bone- conduction tinnitus masker | Provide ultrasonic broadband noise and/or sweep-frequency stimuli noise of sufficient intensity and bandwidth to mask tinnitus. | C |
8 | Ear prosthesis | Used to reconstruct external ear by replacing damaged or missing tissue. | C |
9 | Spinal needle bioimpedance navigation unit | Transmit and receive electrical signals to/from a dedicated spinal needle to analyse bioimpedance data in real-time, to foresee needle tip location. | D |
10 | Epidural anaesthesia kit | A group of medical devices is used to deliver an analgesic or anaesthetic agent to the epidural space for pain management. | C |
11 | Tracheostomy kit | A group of surgical instruments, dilators, tracheostomy tubes and other items are used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve the upper airway obstruction and facilitate ventilation. | C |
12 | Cardiopulmonary bypass pulsatile flow generator | An electrically and pneumatically operated device is intended to create pulsatile blood flow. This medical device is placed in a cardiopulmonary bypass circuit downstream from the oxygenator. | D |
13 | Hemodialysis Catheter (Long Term) | This medical device is used for exchanging blood to and from the haemodialysis machine the patient. The dialysis catheter consists of two lumens: Venous and Arterial | C |
14 | Haemodialysis Concentrate | Used to remove metabolic waste from the blood to help in maintaining physiological blood electrolyte and pH levels while haemodialysis is performed | C |
CDSCO which is administrated by the Ministry of Health and Family Welfare (MOHFW) is in the process of regulating class C and D Non-notified medical devices / IVD under Medical Device Rule (….Amendment) 2019 for manufacturers and importers. Class C and D medical devices / IVDs manufacturers will need to obtain a valid manufacturing license from the regulated authority (CDSCO) on or before 1 October 2023.
CliniExperts’ team has phenomenal expertise in providing support for manufacturing medical devices and IVDs. We are willing to join together with medical device and IVD manufacturers across India to offer end-to-end regulatory support for Medical Devices and In-Vitro Diagnostic Kit according to the manufacturer’s need.
CliniExperts is making sure that all measures are taken to support MD/IVD manufacturers and help them to achieve their objectives so that India becomes self-sufficient in terms of manufacturing Medical Devices and IVDs.
CliniExperts’ professionals are proficient and have years of experience in offering regulatory support for manufacturing licenses for class c and d MD / IVD. We closely work with regulatory bodies to evaluate what is expected when they visit.
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