Resources
100 results
Public notice on draft Recruitment rules for the post of LDC Central Drugs Laboratory Kolkata
India · Pharmaceuticals
Regulation of CT scan equipment_All Implantable Devices_MRI equipment etc. as Drugs with effect from April 1st 2021
India · Medical Devices
Notice regarding Review of regulatory regime for drug approval
India · Pharmaceuticals
Module for online processing of applications for registration of BA BE study centres (CT-08)
India · Medical Devices
Organization of Voluntary Blood Donation Day Camp in Nirman Bhawan Premises on 01.10.2021 from 09.00 AM onwards
India · Medical Devices
Submission of Post Approval Changes Applications through SUGAM Portal
India · Medical Devices
Classification of Medical Device pertaining to Neurological under the provisions of Medical Devices Rules, 2017
India · Medical Devices
Registration and Labelling requirements of Medical Devices
India · Medical Devices
Classification of Medical Device pertaining to Gastroenterology under the provisions of Medical Devices Rules, 2017
India · Medical Devices
Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of Medical Devices
India · Medical Devices
Classification of Medical Device pertaining to Pain Management under the provisions of Medical Devices Rules 2017
India · Medical Devices
Classification of Medical Device pertaining to Operation Theatre under the provisions of Medical Devices Rules 2017
India · Medical Devices
Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of Medical Devices Rules 2017
India · Medical Devices
Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of Medical Devices Rules 2017
India · Medical Devices
Classification of Medical Device pertaining to Software under the provisions of Medical Devices Rules 2017
India · Medical Devices
Timelines for activities requiring minor and major procedures for cargo clearances at port offices of CDSCO
India · Medical Devices
Online Application for issuance of Written Confirmation Certificate WCC regarding
India · Medical Devices
The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded by BIS for ready reference
India · Medical Devices
Manufacturing and marketing of FDC of Tolperisone HCL 150mg + Paracetamol IP 500mg tablet
India · Pharmaceuticals
Procedure to be followed for regularisation of FDCs declared as rational in respect of 249 FDCs by the DTAB which were licensed to manufacture and market by SLA without prior approval from DCG(I)
India · Medical Devices
List of Medical devices testing Laboratory for carry out test or evaluation of Medical device on behalf of Manufacturer registered with CDSCO under MDR
India · Medical Devices
Procedure to be follow for reqularisation of 19 FDCs out of 294 FDCs which required further generation of data which were licensed to manufacture and market by SLA withoout prior approval from DCG(I)
India · Medical Devices
Manufacturing and marketing of certain FDCs as per directions of Hon'ble High Court Maharashtra Nagpur Bench
India · Medical Devices
Classification of Medical Device Pertaining to Pediatrics and Neonatology Under the provision of Medical Devices Rules 2017
India · Medical Devices
PCR Kits approved for testing of Covid-19 as on 23.08.2021
India · Medical Devices
Classification of Medical Device Pertaining to Urology Under the provision of Medical Devices Rules 2017
India · Medical Devices
Evaluation of Certain Pre-1988 Permitted Fixed Dose Combinations (FDCs) De novo for manufacture for sale in the country without due approval from Central Licensing Authority
India · Pharmaceuticals
Classification of Medical Devices Pertaining to Ophthalmology under the Provisions of Medical Devices Rules 2017
India · Medical Devices
Classification of Medical Device Pertaining to Radiotherapy under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021
India · Medical Devices
Classification of Medical Devices Pertaining to ENT under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021
India · Medical Devices
Classification of Medical Device Pertaining to Respiratory Under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021
India · Medical Devices
Notice and additional set of FAQ Cosmetics division dated 06.08.2021
India · Cosmetics
Inviting Public comments, as steps are being taken by CDSCO to regulate the products like skin patches which are being used as cosmetic
India · Cosmetics
Notice Evaluation of Certain pre 1988 permitted FDC de novo for manufacture of Sale in the Country without due approval from Central Licensing Authority
India · Medical Devices
Classification of Medical Device Pertaining to Physical Support under the Provisions of Medical Devcies Rules 2017
India · Medical Devices
Classification of medical device pertaining to Cardiovascular under the provisions of Medical Devices Rules 2017
India · Medical Devices
Classification of Medical Device Pertaining to Interventional Radiology under the Provisions of Medical Devcies Rules 2017
India · Medical Devices
Classification of Medical Device Pertaining to Dermatological and Plastic Surgery under the Provisions of Medical Devcies Rules 2017
India · Medical Devices
Classification in IVD medical devices under the provision of MD Rules 2017
India · Medical Devices
Classification of medical devices pertaining of Anesthesiology under the provision of Medical Devices Rules 2017
India · Medical Devices
List of medical devices testing laboratory for carry out test or evaluation of medical device on behalf of manufacturer with CDSCO under MDR 2017
India · Medical Devices
Notice Module for online processing of applications for issuance of Written Confirmation Certificate
India · Medical Devices
Public notice on draft Recruitment rules for the post of Stenographer Grade-II in CDL, Kolkata
India · Medical Devices
Guidance for approval COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for rrestriced use by US FDA
United States of America · Biologics
Update on Information on Convalescent Plasma in COVID-19
India · Medical Devices
Advisory regarding Oxygen Concentrators suitable for COVID-19 case management in Home settings
India · Medical Devices
SOP Guidance for import of vaccine by private sector or any person
India · Biologics
Supply of essential In-Vitro Diagnostic testing reagents / kits for inflammatory markers such as IL-6 (Interleukin 6), D-Dimer and C-reactive protein (CRP)
India · Medical Devices
Regulation of CT Scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st 2021
India · Medical Devices
Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are
United States of America · Biologics
Public notice hearing on irrational FDCs which meeting to be held from 19.04.2021 to 07.05.2021 by DTAB Subcommittee
India · Medical Devices
Enforcement activities to stop hoarding/back marketing/overcharging of COVID Managment drug Remdesivir
India · Pharmaceuticals
Monitoring to ensure availability of Remdesivir and prevent its hoarding and black marketing
India · Medical Devices
NDLS portal Public notice-31-03-2021
India · Medical Devices
Meeting of DTAB Sub Committee through WebEx (Video Conference) w.e.f. 19.04.2021 to 07.05.2021 for examining the Fixed Dose Combinations (FDCs) considered as irrational by Prof. Kokate Committee and t
India · Pharmaceuticals
Mentioning of analytical sensitivity of HIV p24 antigen in 4th generation HIV kits
India · Medical Devices
Reconstituting of Internal Complaint Committee on sexual Harassment cases regarding
India · Medical Devices
Meeting of DTAB Sub Committee for examining the Fixed Dose Combinations (FDCs) considered as irrational by Prof. Kokate Committee and to provide hearing to the stakeholders-regarding.
India · Pharmaceuticals
Notice-Online Application for the issuance of Form 41 (Registration certificate) and Form 10 (Import License) for Veterinary Vaccines
India · Veterinary Products
Notice issued by DCG(I) regarding implementation of SUGAM Online system for reporting of SAE's
India · Medical Devices
Notice regarding FAQ/Guidance Document for grant/retention of registration certificate/license for import or manufacture of cosmetics in India under the Cosmetics Rules 2020
India · Cosmetics
Month wise Tentative schedule of SEC (Vaccine) meetings of the year 2021
United States of America · Biologics
Regulation of Blood Glucose monitors Blood pressure monitors Nebulizers and Thermometers as drugs with effect from Jan 1st 2021
India · Pharmaceuticals
Submission of notarized/apostilled documents for Import and Registration of cosmetics in view of COVID-19
India · Cosmetics
Oreventive measure to contain spread of COVID-19 in CDSCO HQ attendance of Central Government officicals regarding
India · Medical Devices
Notice regarding List of medical devices testing Laboratory
India · Medical Devices
Notice for Vaccine Guidelines dated 21 Sept 2020
India · Biologics
Regulatory guidelines for development of Vaccine 21.09.2020
India · Biologics
Notice regarding documents required for the Import
India · Medical Devices
Procedure to be followed for regularisation of FDCs declared as rational in respect to 294 FDCs by the DTAB which were licensed to manufacture and market by SLA without prior approval from DCG(I)
India · Medical Devices
Online Application for Free Sale certificate Market standing certificate and Non-conviction certificate of Notified Medical Devices
India · Medical Devices
Requirement of fees for change in address of authorized agent without change in constitution as post approval Change under MDR 2017
India · Medical Devices
Submission of notarized/apostilled documents for import of medical device and in-vitro diagnostic kits in view of Covid-19
India · Medical Devices
Notice regarding Approved panel of experts for the Subject Expert Committees
India · Medical Devices
Submission of notarized/ apostilled documents for import and Registration of cosmetics in view of COVID-19
India · Cosmetics
Information on convalescent plasma in Covid 19
India · Medical Devices
Clarification regarding import of diagnostic kits reagents for Research use only ROU for academic research purpose
India · Medical Devices
Clarification regarding import of diagnostic kits/ reagents for Research use only ROU for academic research purpose
India · Medical Devices
Conduct of BA-BE Study for Export purpose in present situation due to outbreak of COVID-19
India · Medical Devices
GUIDELINES FOR VALIDATION AND BATCH TESTING OF COVID-19 DIAGNOSTIC KITS
India · Medical Devices
Radpid Response Regulatory Framework for COVID-19 vaccine development
India · Biologics
Advisory Notice regarding voluntary registration of personal protection equipment coveralls at CDSCO and ites testing at Labs recognised by Ministry of Textiles
India · Medical Devices
ICMR Convalescent plasma _protocol_v1.5.pdf
India · Medical Devices
Extension of validity of WHO GMP/Certificate of Pharmaceutical Product (COPP)
India · Pharmaceuticals
Notice inviting quotation Chemicals for Central Drugs Laboratory, Kolkata 27 April
India · Pharmaceuticals
Submission of notarized/apostilled document for import and registration of medical devices in view of covid-19
India · Medical Devices
amended Clinical Trial protocol version 1.4 by ICMR dated 2020-04-22_on convalescent plasma_protocol_v1.4
India · Pharmaceuticals
Submission of notarized/ appoostiled documents for import and registration of cosmetics in view of COVID 19
India · Cosmetics
Clinical trial of convalescent plasma in COVID-19 Patients
India · Pharmaceuticals
Advisory issued by Ministry of Health and Family Welfare, Govt. of India to spread awareness to general public for the use of COVID-19 medicines
India · Pharmaceuticals
Office Memorandum on COVID-19
India · Medical Devices
Submmission of notarized/apostilled documents for import and Registration of drugs in view of COVID 19
India · Pharmaceuticals
Granting permission to manufacturers of industrial oxygen to manufacture oxygen for medical use in the light of Covid-19
India · Medical Devices
Public notice alerting about unlicensed kit of Bione for corona testing displayed on their website for sale
India · Medical Devices
Notice regarding conduct on clinicl trial in present situation due to outbrea of COVID-19
India · Medical Devices
Release of consignments of Vaccine and critical IVDs-certain instructions issued
India · Biologics
Examples of hand sanitisers/surgical hand disinfectant approved by CDSCO including the WHO formula for reference purposes
India · Medical Devices
Notice regarding COVID-19 outbreak
India · Medical Devices
OM on Rapid Response Regulatory Framework for COVID-19
India · Medical Devices
Notice regarding Regulatory pathway for R&D of Drug or vaccine for COVID-19
India · Biologics