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complete procedure to meet

Complete Procedure to Meet the CDSCO License Mandate of Class C & D Non-Notified Medical Devices

Overview of the CDSCO License Mandate The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body that manages medical device registration in India under the Ministry of Health & Family Welfare. The main aim of CDSCO is to ensure that medical devices are...

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GCT, CDSCO, RCGM, DCGI, GCP, India, CliniExperts, Form 44, Form 12, CTRI, Ethics committee

India has been an attractive destination for clinical trials because of its large population and varied demographics. Despite having tremendous potential, only 1–2% of global clinical trials are being conducted in India....

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Medical Device, Coronary Stents, Heart valves, NLEM, CDSCO, CliniExperts

  National List of Essential Medicines The National List of Essential Medicines (NLEM), 2011, has been reviewed and revised by the Core-Committee constituted by the Ministry of Health & Family Welfare (MOHFW),...

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Human Biological Samples, Saliva, Blood, DNA fingerprint, tissue samples, blood samples, urine samples

  As per the Director General of Foreign Trade (DGFT) via. the notification on August 4, 2016, (Notification No. 19 /2015-2020), an amendment in the policy of the import and export of...

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The Central Drugs Standard Control Organization (CDSCO) plays an important role in safeguarding and enhancing public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. It is...

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stethoscope in two years, preferring to examine his patients with a handheld ultrasound unit to view a patient’s heart in real-time. In 2012 alone, physicians in the U.S. are expected to increase...

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In order to strengthen the scientific review and approval of new drugs/devices, the ministry has appointed 12 New Drug Advisory Committee’s (NDAC), Subject Expert Committees (SEC) and 7 Medical Device Advisory Committee’s...

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It is acknowledged within the pharmaceutical industry that clinical trials represent the single most expensive aspect of a drug, or treatment, development process. Specifically, clinical trials are enormously resource-intensive and involve repetitive,...

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What is a New Drug as per Drug and Cosmetic Rules (D&C)? As per Rule 122 E of the Drug and Cosmetic Rules 1945, a New Drug can be – [1] A...

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