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Dipak Bhargava
Jun 22, 20242 min read
MEDICAL DEVICE ADVERSE EVENT REPORTING FORM
The Materiovigilance Programme of India (MvPI) was approved and initiated by the Ministry of Health & Family Welfare, Government of India...
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Dipak Bhargava
Jun 22, 20241 min read
Guidance Document on Risk Based Approach for Monitoring Quality at the Ports of Import
The Drugs Controller General (India) oversees all port offices of the Central Drugs Standard Control Organization (CDSCO). CDSCO, through...
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Dipak Bhargava
Jun 22, 20241 min read
Pharmacovigilance requirements for biological products
Guidance Documents pharmacovigilance requirements for biological products India has emerged as a prominent center for vaccine...
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Dipak Bhargava
Jun 22, 20242 min read
Guidance on Stability Studies of In-vitro DiagnosticMedical Device(IVDMD)
The CDSCO has issued a draft guidance document on stability studies for In-vitro Diagnostic Medical Devices (IVDMD) to assist...
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Dipak Bhargava
Jun 16, 20244 min read
Regulators in India
The Central Drugs Standard Control Organization (CDSCO) is a regulatory agency that establishes strict criteria that any drug, medical...
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