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CDSCO - Public Notices
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CDSCO - Public Notices
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CDSCO - Public Notices
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CDSCO - Public Notices
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CDSCO - Public Notices
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CDSCO - Public Notices
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CDSCO - Public Notices
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CDSCO - Public Notices
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CDSCO - Public Notices
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Separate provision for subsequent Importer in Online system for Medical Devices
▶ Summary
This document is a circular issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO) regarding a separate provision for 'Subsequent Importer' in the online system for medical devices. It details regulatory changes to simplify import application procedures for already approved medical devices and in-vitro diagnostics. The circular is directed towards stakeholders and state licensing authorities, aiming to improve transparency and efficiency in regulatory approvals.
|
order |
CDSCO - Public Notices
Unknown
|
Sep 15, 2025
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Regulatory requirements for outsourcing sterilization activity of medical device...
▶ Summary
This document contains the minutes from the 92nd meeting of the Drugs Technical Advisory Board (DTAB) that was held on April 24, 2025, in a hybrid format. The minutes, approved by the Chairman, include the discussion on a proposal related to the no requirement of loan license application for sterilization purposes under specific conditions is included. It was issued by the Central Drugs Standard Control Organisation, part of the Ministry of Health & Family Welfare, India.
|
document |
CDSCO - Public Notices
Unknown
|
Jun 24, 2025
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Provision for auto-generated Market Standing Certificate and Non-Conviction Cert...
▶ Summary
This is a public notice issued by the Central Drugs Standard Control Organization (CDSCO) outlining the new provisions for obtaining Market Standing Certificates and Non-Conviction Certificates for licensed medical devices. The notice explains an update in the online application system that will require stakeholders to re-submit applications under the new workflow due to an upgrade to auto-generate these certificates. The notice is meant to inform stakeholders of these procedural changes to simplify regulatory processes.
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public notice |
CDSCO - Public Notices
Unknown
|
Apr 09, 2025
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Provision for system auto-generated Neutral Code by the manufacturer for the exp...
▶ Summary
This is a public notice issued by the Central Drugs Standard Control Organization (CDSCO) under the Government of India concerning the implementation of a new system for auto-generated Neutral Codes under the Medical Devices Rules, 2017. The notice informs manufacturers about the transition to a new online provision for obtaining Neutral Codes for export purposes, which replaces the previous system managed by the Central Licensing Authority. Stakeholders are instructed to use the new procedure through the Medical Devices portal.
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public notice |
CDSCO - Public Notices
Unknown
|
Apr 09, 2025
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Provision for system auto-generated Neutral code by the manufacturer for the exp...
▶ Summary
This public notice from the Directorate General of Health Services, CDSCO, informs stakeholders about a new provision for system auto-generated Neutral Codes under the Medical Devices Rules, 2017. This change aims to facilitate the export process and ease of doing business by replacing the current manual issuance by the Central Licensing Authority. Stakeholders are advised to use the online portal for obtaining these codes.
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public notice |
CDSCO - Public Notices
Unknown
|
Apr 09, 2025
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Seminar on Strengthening Medical Device Licence Holders on Post-Market Safety Su...
▶ Summary
This document is a public notice regarding a seminar organized by the Indian Pharmacopoeia Commission under the Materiovigilance Programme of India (MvPI). The seminar, scheduled for September 3, 2024, in Chandigarh, aims to educate medical device stakeholders on post-market safety surveillance practices and the relevant regulatory landscape in India. It invites manufacturers, importers, distributors, and healthcare professionals to enhance their understanding and compliance with safety and quality management systems.
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public notice |
CDSCO - Public Notices
Unknown
|
Jul 26, 2024
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
02.06. 2023 G.S.R 409(E) Medical Devices
▶ Summary
This document is an official notification from the Ministry of Health and Family Welfare of India, detailing amendments to the Medical Devices Rules, 2017. It announces the establishment of State Medical Devices Testing Laboratories and clarifies the roles of both Central and State Governments concerning medical device regulation. The notification invites public objections and suggestions, underpinning the government's consultative process in regulatory amendments.
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public notice |
CDSCO - Public Notices
Unknown
|
Jun 02, 2023
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Medical Device Alert dated 08 May 2023
▶ Summary
This is a medical device alert issued by the Central Drugs Standard Control Organization (CDSCO) regarding the recall of HOYA Vivinex iSert Toric Intraocular Lenses. The recall is due to reported damage such as scratches and fragments adhering to the IOL surface. This alert, classified as a Class II recall, provides detailed reasons for the recall and further contact information.
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advisory |
CDSCO - Public Notices
Unknown
|
May 08, 2023
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Medical Device Alert dated 29 Dec 2022
▶ Summary
This document is a medical device alert from the Central Drugs Standard Control Organization (CDSCO) regarding the MitraClip™ G4 and MitraClip™ NTR/XTR Clip Delivery Systems used for mitral valve repair. It addresses observed malfunctions such as 'Establish Final Arm Angle' failures and 'Clip Opening While Locked' events, providing guidance for healthcare providers on managing these issues. The alert includes contact information, and it mentions that no complaints have been received by CDSCO despite a safety notice from the manufacturer, St. Jude Medical India Pvt. Ltd.
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advisory |
CDSCO - Public Notices
Unknown
|
Jan 04, 2023
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Applicant User Manual For Form MD-41
▶ Summary
This document is an Applicant User Manual for Form MD-41, which is used in the online system for selling, stocking, and distributing medical devices. It is issued by the CDSCO and provides detailed instructions on how users can register, fill in necessary details, submit applications, and complete other necessary steps within the online system. The manual facilitates new users to navigate through the system starting from registration to final submission.
|
document |
CDSCO - Public Notices
Unknown
|
Nov 18, 2022
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Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
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G.S.R. 777(E) 14 Oct 2022 Final notification for exemption of non sterile and no...
▶ Summary
This document is an extraordinary notification published by the Government of India, detailing amendments to the Medical Devices Rules, 2017. It announces changes to the registration and categorization of certain non-steroidal and non-measuring medical devices, with guidelines and procedural requirements for manufacturers and importers. The notification requests public feedback on these amendments by a specified date.
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public notice |
CDSCO - Public Notices
Unknown
|
Oct 14, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
MDR_G.S.R. 777(E) dt_14.10.2022_exemption of non sterile and non measuring Class...
▶ Summary
This document is an extraordinary public notice from the Ministry of Health and Family Welfare, Government of India, stating an amendment to the 2017 Medical Device Rules under the Drugs and Cosmetics Act, 1940. It outlines the regulations concerning registration and compliance for certain classes of medical devices, focusing on non-sterile and non-measuring devices, and invites affected parties to submit feedback and suggestions. The document specifies procedural details for manufacturers and importers involved in medical device registration and compliance.
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public notice |
CDSCO - Public Notices
Unknown
|
Oct 14, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
GSR 754 (E) 30-09-2022 sale of medical device retail and wholesale
▶ Summary
This document is an extraordinary gazette notification published by the Ministry of Health and Family Welfare of the Government of India, detailing amendments to the Medical Devices Rules, 2017. It includes amendments related to the registration of medical devices, specifying procedures and requirements for obtaining registration certificates. The notice invites public comments and suggestions on the proposed rules and outlines the necessary steps for compliance by individuals or organizations involved in the sale, stock, or distribution of medical devices.
|
public notice |
CDSCO - Public Notices
Unknown
|
Sep 30, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
2022.09.28_S.O._4573(E)_Notification for designation of RDTL Chandigarh also as ...
▶ Summary
This document is a public notice from the Ministry of Health and Family Welfare, published in the Gazette of India. It announces an amendment to a previous notification related to medical devices under the Medical Devices Rules, 2017. The amendment specifies the listing of a new laboratory, the Regional Drugs Testing Laboratory in Chandigarh, for certain disposable medical devices.
|
public notice |
CDSCO - Public Notices
Unknown
|
Sep 28, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
2022.09.20_Draft_GSR 710(E)_Exemption of certain Class A medical device from lic...
▶ Summary
This is a public notice issued by the Ministry of Health and Family Welfare of the Government of India, published on September 20, 2022. The notice includes draft amendments to the Medical Device Rules, 2017, concerning the registration of Category A non-sterile and/or non-temperature controlled medical devices. It invites objections and suggestions within a specified period, demonstrating regulatory changes that affect stakeholders in the medical device industry.
|
public notice |
CDSCO - Public Notices
Unknown
|
Sep 20, 2022
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
2022.08.02_S.O. 3739(E)_Notification of Medical Devices Testing Officer for CMDT...
▶ Summary
This document is a public notice issued by the Ministry of Health and Family Welfare in India, designating specific government analysts as Medical Device Testing Officers for various medical devices including condoms, surgical dressings, and diagnostic kits. The notice, published on August 2, 2022, in the Gazette of India, outlines the relevant officials and their associated testing responsibilities for the specified medical devices across different laboratories.
|
public notice |
CDSCO - Public Notices
Unknown
|
Aug 02, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Medical Device Alert date 21 July 2022
▶ Summary
This document is a medical device alert issued by the Central Drugs Standard Control Organization (CDSCO) regarding the Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C. The alert highlights a recall by Baxter Healthcare Corporation due to the presence of particulate matter within the cartridges, which could pose serious health risks if undetected. It serves as an advisory for healthcare providers and users of the affected devices, providing contact information for further details.
|
advisory |
CDSCO - Public Notices
Unknown
|
Jul 21, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Medical Device Alert date 21 June 2022
▶ Summary
This document is a medical device alert issued by the Central Drugs Standard Control Organization (CDSCO) regarding the Palmaz Genesis Peripheral Stent on Opta Pro Delivery System, which has shown an increased complaint rate for stent dislodgement. The alert details the potential risks associated with this issue, such as intra-procedural delays and possible complications like surgical intervention or trauma. The alert emphasizes that the recall is due to these issues found predominantly in products manufactured between October 2019 and April 2021, with no reports of deaths or long-term health effects to date.
|
advisory |
CDSCO - Public Notices
Unknown
|
Jun 21, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
2022.06.15_Final GSR 450(E)_To amend Fourth Schedule wrt TSE or BSE certificate ...
▶ Summary
This document is a notification issued by the Ministry of Health and Family Welfare, India, published in the Gazette of India on June 15, 2022. It details amendments to the Medical Devices Rules, 2017, highlighting changes specifically about requirements for Transmissible Spongiform Encephalopathies (TSEs) or Bovine Spongiform Encephalopathy (BSE) Certificates under certain conditions. The notification follows a public consultation process where objections and suggestions were invited and considered.
|
public notice |
CDSCO - Public Notices
Unknown
|
Jun 15, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Medical Device Alert date 14 June 2022
▶ Summary
This document is a public notice alert issued by the Central Drugs Standard Control Organization (CDSCO) about a potential safety issue with specific Medtronic staplers used in surgeries. The notice addresses the possibility of the staple guide not being securely attached, which could lead to serious complications during surgical procedures. CDSCO has included details regarding the recall and the Field Safety Corrective Action initiated by the manufacturer to address the issue.
|
public notice |
CDSCO - Public Notices
Unknown
|
Jun 14, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
2022.05.18_Final GSR 356(E)_Insert rule 43A for Suspension and cancellation of l...
▶ Summary
This document is a public notice issued by the Ministry of Health and Family Welfare, Government of India, announcing amendments to the Medical Devices Rules, 2017. It details the new rule for the suspension and cancellation of a license, allowing for objections and suggestions from affected parties prior to its implementation. The notice highlights the process and timelines for appealing decisions made by the Central Licensing Authority.
|
public notice |
CDSCO - Public Notices
Unknown
|
May 18, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
2022.02.09_Draft GSR 104(E)_Regulation of sale of medical devices via registrati...
▶ Summary
This official public notice from the Ministry of Health and Family Welfare, published on February 9, 2022, outlines proposed amendments to the Medical Device Rules, 2017. It details the procedure for objections or suggestions from individuals affected by these rules, including sending feedback to a specified government address or email. The document invites public comments within 45 days upon availability of the drafts in the Gazette of India.
|
public notice |
CDSCO - Public Notices
Unknown
|
Feb 09, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Medical Devices Alert 8 November 2021
▶ Summary
This document from the Central Drugs Standard Control Organization (CDSCO) is a medical device alert concerning Medtronic's recall of remote controllers used with MiniMed insulin pumps due to cybersecurity risks that could potentially lead to serious health issues for users. The alert specifies that unauthorized individuals could manipulate the wireless communications between the remote and the insulin pump, posing risks such as hypoglycemia or diabetic ketoacidosis. Users and healthcare providers are advised to stop using the devices and follow specific steps for returning them to Medtronic.
|
advisory |
CDSCO - Public Notices
Unknown
|
Nov 08, 2021
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Medical Devices Alert on MiniMed 620G Insulin Pump/Pump Kits & MiniMed 640G Insu...
▶ Summary
This document is a medical device alert issued by the Central Drugs Standard Control Organization (CDSCO) regarding the MiniMed 600 Series insulin pumps by Medtronic. The alert details a recall due to a potential issue with the pump's retainer ring, which can lead to incorrect insulin dosing and pose serious health risks. It includes contact information for affected users and healthcare providers for further assistance.
|
advisory |
CDSCO - Public Notices
Unknown
|
Oct 11, 2021
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Alert_FSN-Medtronic Heartware HVAD
▶ Summary
The document is a public notice from the Central Drugs Standard Control Organization (CDSCO) regarding the HeartWare HVAD System. It alerts medical professionals of Medtronic's decision to halt the distribution and sale of this device due to increased risks of neurological adverse events and potential device failure. The notice outlines immediate actions for users and mentions no complaints have been received in the market.
|
public notice |
CDSCO - Public Notices
Unknown
|
Sep 17, 2021
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Medical Devices alert for Ventilator of Philips August 2021
▶ Summary
This document is a medical device alert issued by the Central Drugs Standard Control Organization regarding certain CPAP and BiPAP devices and mechanical ventilators produced by Philips India Limited. The alert informs users of a Field Safety Notice due to potential issues with sound abatement foam in these devices, advising immediate actions for users, including consultation with physicians and discontinuation or continued use under medical advice. Philips is addressing the problem through corrective actions, including replacing problematic foam.
|
advisory |
CDSCO - Public Notices
Unknown
|
Aug 09, 2021
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Medical Devices alert july 2019
▶ Summary
This document is an advisory issued by the Central Drugs Standard Control Organization (CDSCO) regarding cybersecurity vulnerabilities in specific Medtronic insulin pumps. It provides detailed instructions for users and healthcare professionals on precautions to take to mitigate potential risks. The advisory highlights warnings about possible unauthorized wireless access to the devices that could affect insulin delivery and provides guidance on seeking secure alternatives or updates.
|
advisory |
CDSCO - Public Notices
Unknown
|
Jul 02, 2019
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Medical Device Adverse Event Reporting Form
▶ Summary
This document is a medical device adverse event reporting form associated with the Materiovigilance Programme of India. It is meant for the voluntary reporting of any adverse events related to medical devices by manufacturers, importers, distributors, healthcare professionals, and others with relevant information. Reporting instructions and contact details for the Indian Pharmacopoeia Commission are provided, but the form itself is primarily for data collection and not an official announcement or advisory.
|
document |
CDSCO - Public Notices
Unknown
|
Apr 09, 2019
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
FSCA Form
▶ Summary
This document is a Field Safety Corrective Action Notification Form that must be submitted to the Central Drugs Standard Control Organization (CDSCO) for medical device product recalls or other corrective actions as per the Medical Devices Rules, 2017. The form requires detailed information about the device, the nature of the corrective action, and the related adverse events, along with declarations from the reporting person. This notification is intended for public dissemination on the CDSCO website and holds the reporter accountable for the information supplied.
|
public notice |
CDSCO - Public Notices
Unknown
|
Apr 09, 2019
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Frequently Asked Questions on Medical Device Rule 2017
▶ Summary
This document, issued by the Central Drugs Standard Control Organization (CDSCO) of India, provides detailed answers to frequently asked questions pertaining to the Medical Device Rules of 2017. It is intended to create public awareness about regulations concerning medical devices but cautions that it should not be used for legal or professional purposes. Key topics include license validity, application procedures, and transitional timelines under the new rules.
|
document |
CDSCO - Public Notices
Unknown
|
Dec 28, 2018
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
Guidance Documents on Free Sale Certificate of Notified Medical Devices in India
▶ Summary
This document is a guidance issued by the Central Drugs Standard Control Organization (CDSCO) about the process for obtaining a Free Sale Certificate for notified medical devices in India. It provides detailed instructions for Indian manufacturers, including submission requirements, necessary documentation, and fees. The guidance is meant to assist in exporting medical devices and ensures compliance with the Medical Devices Rules 2017.
|
document |
CDSCO - Public Notices
Unknown
|
Nov 06, 2018
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Guidance on Performance Evaluation of In-vitro Diagnostic Medical Devices
▶ Summary
This document provides guidance on the performance evaluation of in-vitro diagnostic medical devices as per the Medical Devices Rules 2017. It outlines the requirements for manufacturers to submit performance evaluation reports and lists the specific types of tests and laboratories approved for conducting evaluations. The document is issued to guide compliance with regulations concerning medical device testing in India.
|
document |
CDSCO - Public Notices
Unknown
|
Aug 10, 2018
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Grant of additional products & certificates like i.e. Market standing certificat...
▶ Summary
This document is a public notice issued by the Central Drugs Standard Control Organisation (CDSCO) under the Government of India. It addresses the grant of additional products and certificates such as the Market standing certificate concerning Medical Devices and In Vitro Diagnostics. The notice clarifies procedural queries and refers stakeholders to the CDSCO website FAQs for more detailed information.
|
public notice |
CDSCO - Public Notices
Unknown
|
Aug 08, 2018
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
The National Coordination Centre (NCC)-Materiovigilance Programme of India (MvPI...
▶ Summary
This is a guidance document for medical devices prepared by the Indian Pharmacopoeia Commission under the Ministry of Health & Family Welfare, Government of India. It outlines standards and regulatory requirements for medical devices in India based on the Medical Device Rules, 2017. The document serves as a reference for stakeholders such as manufacturers, regulators, and healthcare professionals, aiming to ensure compliance with existing standards and improve patient safety.
|
document |
CDSCO - Public Notices
Unknown
|
Aug 06, 2018
|
Dec 15, 2025
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pdf ↓ | ✗ Filtered |
|
Quality Control testing of viral load monitoring kits for HIV, HCV and HBV-Reg
▶ Summary
This document is an official public notice issued by the Central Drugs Standard Control Organisation (CDSCO) detailing the quality control testing of viral load monitoring kits for HIV, HCV, and HBV. It informs relevant stakeholders that the National Institute of Biologicals (NIB) has been equipped and certified to conduct these tests, encouraging referrals of kits for evaluation. The notice requests action to submit these kits alongside import/manufacture licenses for testing.
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public notice |
CDSCO - Public Notices
Unknown
|
Jul 24, 2018
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Document 13761
▶ Summary
This is a guidance document issued by the Central Drugs Standard Control Organization (CDSCO), focusing on the Drugs and Cosmetics (Compounding of Offences) Rules, 2025. It details the legal framework for compounding offences within the act, including procedures for application, roles of authorities, and conditions for granting immunity from prosecution. The document also outlines the changes made through various amendments and explains the role of the compounding authority in processing these offences.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Jan 02, 2026
|
pdf ↓ | ✗ Filtered |
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Document 13760
▶ Summary
This document is a public notice issued by the Central Drugs Standard Control Organization (CDSCO) regarding the compounding of offences under the Drugs and Cosmetics Act, 1940. It announces Dr. Rajshree as the appointed Central Compounding Authority and provides guidelines on how stakeholders can apply for compounding of offences. The notice includes reference to the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 and informs about the availability of related guidelines and SOPs on the CDSCO portal.
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public notice |
CDSCO - Public Notices
Unknown
|
—
|
Jan 02, 2026
|
pdf ↓ | ✓ Relevant |
|
Document 13759
▶ Summary
This document is a Frequently Asked Questions (FAQs) guide about the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 issued by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, Government of India. It provides explanatory details regarding the legal framework, procedure, and authority for compounding offences under the Drugs and Cosmetics Act, 1940, aiming to inform the public about these regulatory measures. The document clarifies the application process, decision-making criteria by the compounding authorities, and conditions under which immunity from prosecution can be handled.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Jan 02, 2026
|
pdf ↓ | ✓ Relevant |
|
Document 13762
▶ Summary
This document details the procedure established by the Central Drugs Standard Control Organization (CDSCO) for the filing, processing, and finalization of applications related to the compounding of offenses under the Drugs and Cosmetics Act, 1940. It outlines the responsibilities of various roles including the Technical Data Associate, Drugs Inspector, and Compounding Authority. The document specifies the steps for granting immunity from prosecution under certain conditions as per the Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Jan 02, 2026
|
pdf ↓ | ✓ Relevant |
|
Document 13753
▶ Summary
This document is an official public notice from the CDSCO detailing the classification of various medical devices related to oncology. It provides a list of devices with their intended use and risk classification, which is crucial for industry compliance and regulatory purposes. The notice helps stakeholders understand the regulatory framework for these medical devices.
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public notice |
CDSCO - Public Notices
Unknown
|
—
|
Jan 02, 2026
|
pdf ↓ | ✓ Relevant |