Central Drugs Standard Control Organization, commonly known as CDSCO is a regulatory body for the Indian medical devices industry, under regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian medical devices and pharmaceuticals. It is a licensing authority which approves any new chemical entity (drug) to import to India.
To launch a medical device, the manufacturer has to adhere to numerous norms set by way of the countrywide regulatory bodies of India. The number one regulatory frame for medical devices in India is the central drugs trendy control organization (CDSCO). The applications for all elegance of scientific gadgets are made to the important licensing Authority (CLA) in which the Drug Controller General of India (DCGI) takes obligation for the approval of manufacturing, registration, import, and sale of medical devices in India. The medical devices might also or won’t want to be registered before the sale. While there may be no want for registration, the producer must gain a no-objection certificate (NOC) from the DCGI before releasing the product inside the marketplace. Whilst the medical device to be launched is imported, it has a fixed of issued steps to be observed like filling of a registration form at the side of the fees. The form will include the applicant’s and manufacturer’s details, product facts, the regulatory fame of the product, info of good manufacturing practices included, and publish-marketing surveillance at the side of an assignment shape. The retailers, stockiest, and importers shall also gain the respective sale licenses from the nation Licensing government (SLA). The nation Licensing Authority is responsible for the control and enforcement of regulations related to the sale, stock, providing on the market of medical devices in India.
Total time for CDSCO Certification Service will be approx. 90 to 120 working days.
Absolute Veritas (AV) will provide end to end solution, documentation, test report, coordination and application process for CDSCO Certification Services.
|Sr. No.||Notified Category||Intended Use||Risk Class|
|1||CT scan Equipment||Use of x-ray source and digitally scanned computer technology to create cross-sectional images of the body.||Class C|
|2||MRI Equipment||It is a medical imaging procedure using radio waves, magnetic fields, and magnetic field gradients to generate images of organs in the body.||Class C|
|3||Defibrillators||It is a device that automatically analyzes the rhythm of heart of cardiac arrest patients and delivers an electrical shock to the heart for restoring the normal rhythm of heart.||Class C|
|4||Dialysis Machine||It is used for acute or chronic kidney failure that filters blood to remove excess water and waste products.||Class C|
|5||PET Equipment||Intended to detect the gamma radiation and positron emitting radionuclides in the body and produce cross-sectional images which reflect the distribution in the body or individual organs.||Class C|
|6||X-Ray Machine||Use of X-rays to diagnose or treat patients by imaging the internal structure of the body to assess the abnormalities in the body.||Class C|
|7||Bone marrow cell separator||It is a general lab equipment to be used to isolate target cells and cells concentrate from bone and blood.||Class B|
|8||Nebulizer||It is device used to administer medications in the form of mist to inhale for respiratory disorders.||Class C|
|9||Blood Pressure Monitoring Devices||It is device used to measure the diastolic and systolic blood pressures.||Class B|
|10||Digital Thermometer||It is device used to record the body temperature.||Class B|
|11||Glucometer||It is a device used to measure the concentration of glucose in blood||Class C|
|12||Organ Preservative Solution||Solution for hypothermic flushing, storage and transport of organs and to maintain the organ vitality during transplant into human recipients.||Class C|