Central Drugs Standard Control Organisation (CDSCO)
The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. It’ s vision is “To Protect and Promote public health in India”. Mission is “To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices”.
CDSCO has initiated a program for regulating quality of Medical Devices in a phased manner.
Besides test report from registered / recognised labs, Manufactures are also required to have quality system certified as per IS 13485
Conformity Testing Labs is the first Lab in India registered with CDSCO for testing the electro medical devices to notified standards. Whereas we can test a wider range of Medical Devices, current Scope of registration under CDSCO include….
|S. No||Products||IS/IEC Standards|
|6.||CT Scan Equipment||Class C|
|7.||MRI Equipment||Class C|
|9.||PET Equipment||Class C|
|10.||X-Ray Machine||Class C|
|11.||Dialysis Machine||Class C|
|12.||Bone marrow cell separator||Class C|
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