Foreign Manufacturers Certification Scheme
ISI Mark Scheme
BIS Registration Scheme (CRS)
BEE Star Labelling
WPC Wireless
MTCTE and TEC
CCOE - PESO
Medical Devices - CDSCO Approvals
Hallmark
DGMS Approvals
EPR and E-Waste
CE Marking
Medical Devices Approvals from The 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. Its headquarters is located in New Delhi and operates through six zonal offices, four sub-zonal offices, thirteen port offices and seven laboratories spread across the country.
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, conduct of Clinical Trials, laying down standards for Drugs, control over the quality of imported Drugs and coordination of activities of State Drug Control Organizations.
CDSCO handles licensing for Manufacture / Imports of Class A, B, C and D medical devices. It also provides licenses for Clinical Investigation.
Schedule for Mandating Registration
Disposable Hypodermic
Syringes
Disposable Hypodermic
Needles
Disposable Perfusion
Sets
Blood Grouping
Sera
Cardiac Stents
Drug Eluting
Stents
Catheters
Intra Ocular
Lenses
I.V. Cannulas
Bone Cements
Heart Valves
Scalp Vein Set
Orthopaedic
Implants
Internal Prosthetic
Replacements
Ablation Devices
Ligatures, Sutures &
Staplers
Intra Uterine Devices
(Cu-T)
Condoms
Tubal Rings
Surgical
Dressings
Umbilical Tapes
Blood/Blood Component
Bags
Organ Preservative
Solution
Nebulizer
Blood Pressure
Monitoring Device
Glucometer
Digital
Thermometer
All Implantable Medical
Devices
CT Scan
Equipment
MRI Equipment
Defibrillators
PET Equipment
X-Ray Machine
Dialysis Machine
Bone Marrow Cell
Separator
Disinfectants &
Insecticides
Ultrasound
Equipment
Requirements for Approval
- legal entity details
- Details of medical device Generic Name, Model, Intended Use Class, Material, Dimension, Shelf Life, Sterile or Non-Sterile, Brand Name etc.
- Certificate of compliance with respect to ISO 13485 standard accredited by NABCB or IAF
- Undertaking duly signed by the manufacturer
- Registration number so generated, shall be mentioned on the label of the medical device
- The importer shall provide the following information for registration
- Selected Medical devices shall be registered with the Central Licensing Authority
- The registration is on voluntary basis for a period of eighteen months wef 1.4.2020 there after it shall be mandatory
- The manufacturer of a medical device shall provide the information for registration covering
- Legal entity importing with specification and standards of the device
- Details of medical device Generic Name, Model, Intended Use Class, Material, Dimension, Shelf Life, Sterile or Non-Sterile, Brand Name etc.
- Certificate of compliance with respect to ISO 13485 standard accredited by NABCB or IAF
- Free sale certificate from country of origin
- Undertaking duly signed by the importer
- Registration number so generated, shall be mentioned on the label of the medical device
