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In India, all Medical Devices are regulated under the Drugs & Cosmetics Act, 1940 and Medical Devices Rules, 2017 made thereunder. control of conception. The National Coordination Centre (NCC)-Materiovigilance Programme of India (MvPI) has released Draft Guidance Document for Medical Devices.
- InVitro Diagnostics
Registration of medical device testing laboratory: The...
- Circulars
Circular-Retention of license or certificates under Medical...
- Medical Devices Rules, 2017
MDR_G.S.R.224(E) dt_18.03.2019_Amendment in Environmental...
- Zonal Offices
Office of the Deputy Drugs Controller (India) Central Drug...
- Cosmetics
Cosmetic is defined under section 3(aaa) of the Drugs and...
- SEC
75th SEC (Analgesic & Rheumatology) Meeting scheduled to be...
- Alerts
he Central Drugs Standard Control Organisation(CDSCO)under...
- Committees
Recommendations of the SEC (Analgesic & Rheumatology) made...
- InVitro Diagnostics
To register Class C and Class D Software as Medical Device (SaMD) in India, you must obtain the MD 9 License from the Central Drugs Standard Control Organization (CDSCO). To import Software as Medical Device (SaMD) into India, you must obtain the MD 15 Import Registration from the 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.
Central medical devices testing laboratory (CMDTL) means a medical devices testing laboratory established or designated by the Central Government under rule 19 of MDR-2017.
mit online applications for Medical Devices regulatory process to CDSCO. It will also enable upload of supporting documents, re.
Registration of medical device testing laboratory: The applicant shall make an application in MD-39 in sugam online portal for grant of registration in MD-40 to medical device (IVDMD) testing laboratory for test or evaluation on behalf of manufacturer.
The New Medical Devices portal provides flexibility for submission and processing of applications online. The process involves the development of the online licensing system for multiple stakeholders like Industry applicants, CDSCO officials from HQ, Zones , Subzones, Port offices, Investigators, medical practitioners.