CDSCO announces the list of Notified Bodies who can audit the manufacturing premises under Medical Device Rules, 2017
The Central Drugs Standard Control Organization (“CDSCO”) has released a list of registered Notified Auditing Bodies on August 6th, 2018 who can audit manufacturing sites...
Continue ReadingCDSCO clarifies on various aspects regarding grant of additional products and certificates under the Medical Devices Rules, 2017
Central Drugs Standard Control Organization (“CDSCO”) has clarified several queries with respect to grant of additional products and certificates like, Market standing certificate, Non-conviction certificate...
Continue ReadingCDSCO issues Performance Evaluation Guidelines of In-vitro Diagnostic Medical Devices for complying with the Medical Devices (Amendment) Rules, 2018
As you are already aware, the Medical Devices (Amendment) Rules, 2018 [MDR 2017], are effective from August 1, 2018. Further to the Rules the Central...
Continue ReadingRetail Pharmacies will no longer sell Oxytocin, hospitals / clinics to contact Karnataka Antibiotics & Pharmaceuticals Ltd. for procuring
In furtherance to the ban on manufacture for sale or distribution of Oxytocin by private manufacturers, the Ministry of Health & Family Welfare (“Ministry”) has,...
Continue Reading“Patient Safety is Everyone’s Responsibility”, says the Ministry of Health and Family Welfare
The Ministry of Health and Family Welfare, Government of India (“Ministry”) came up with a document, which provides a formal institutional framework with respect to...
Continue ReadingCabinet gives a nod to DNA Technology (Use and Application) Regulation Bill, 2018
The DNA Technology (Use and Application) Regulation Bill 2018 (“Bill”) has been approved by the Cabinet. The Bill makes it mandatory for DNA laboratories to...
Continue ReadingDelhi Govt. invites views for finalizing its Advisory addressing excessive charges/refusal/delay in providing medical treatment to victims of crimes / road accidents etc. by private hospitals
The Ministry of Health and Family Welfare of NCT of Delhi, has been receiving a numbers of complaints / allegations against excessive charges and the...
Continue ReadingMinistry of Health and Welfare prescribes minimum standards of facilities and services for Medical Diagnostic Laboratories or Pathological Laboratories
In a pathbreaking move to prescribe minimum standards for Medical Diagnostic Laboratories (or Pathological Laboratories), the Ministry of Health and Welfare has notified the Clinical Establishments (Central...
Continue ReadingGovernment invites stakeholder views on its recently rolled out Consultation Paper on rationalizing Trade Margins in Medical Devices
The National Institution for Transforming India (“NITI”), Government of India has released a Consultation Paper on 8th June, 2018 inviting stakeholder views on rationalizing trade margins...
Continue ReadingMedical Health and Family Welfare Services issues Guidelines for the registration of importers, manufacturers, retailers, distributors, dealers of ultrasonography and imaging machines
The Directorate of Medical Health and Family Welfare Services, Jaipur (“Directorate”) has, by a notification dated 20th March, 2018, issued Guidelines for the registration of...
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