| Title | Type | Source | Release Date | Scraped | Download | Status |
|---|---|---|---|---|---|---|
|
Document 13653
▶ Summary
This document is a public notice issued by the CDSCO regarding the classification of medical devices used in interventional radiology. It lists various devices along with their intended uses and corresponding risk classifications. This notice aims to organize and standardize the classification of these medical devices for regulatory purposes.
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public notice |
CDSCO - Public Notices
Unknown
|
—
|
Dec 30, 2025
|
pdf ↓ | ✓ Relevant |
|
Document 13676
▶ Summary
This document is titled 'MedTech Mitra’s In-Vitro Diagnostic Innovators Handbook' and seems to be an informative resource for individuals or companies involved in the development of in-vitro diagnostics. It appears to be a general educational or guidance document rather than an official notice or directive.
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document |
CDSCO - Public Notices
Unknown
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—
|
Dec 30, 2025
|
pdf ↓ | ✗ Filtered |
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Document 13674
▶ Summary
This public notice announces the cancellation or suspension of registration certificates for various Ethics Committees by the Competent Licensing Authority (CLA) as of the listed dates in 2025. It provides details including the name, address, and registration certificate number of each committee affected. The document serves as an official statement informing stakeholders of these regulatory actions.
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public notice |
CDSCO - Public Notices
Unknown
|
—
|
Dec 30, 2025
|
pdf ↓ | ✓ Relevant |
|
Document 13733
▶ Summary
This document is an order from the Central Drugs Standard Control Organization (CDSCO) regarding the cancellation of the registration of the cosmetic product QR 678-Neo. The order states that the product's claims violate the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020. The cancellation is due to non-compliance with labeling claims related to medical benefits, marking it as a drug rather than a cosmetic.
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order |
CDSCO - Public Notices
Unknown
|
—
|
Dec 30, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - Public Notices
Unknown
|
—
|
Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - Public Notices
Unknown
|
—
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Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - Public Notices
Unknown
|
—
|
Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - Public Notices
Unknown
|
—
|
Dec 16, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - Public Notices
Unknown
|
—
|
Dec 16, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - Public Notices
Unknown
|
—
|
Dec 16, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - Public Notices
Unknown
|
—
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Dec 16, 2025
|
— | ⚠ Unavailable | |
|
26MD.pdf
▶ Summary
The document is a detailed checklist for applicants seeking permission to import or manufacture medical devices without predicate devices, under the Medical Devices Rules, 2017. It outlines necessary documents and information for submission, including design analysis, regulatory status, risk management, and clinical investigation data. The document serves as a guide for compliance with regulatory requirements for medical devices in India.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
ChecklisFormMD-22MD.pdf
▶ Summary
The document provides a comprehensive checklist required for obtaining permission to conduct a clinical investigation under Form MD-23 as per the Medical Devices Rules, 2017. It includes items such as the application in Form MD-22, justification for the class of the device, regulatory status, design analysis data, and various study-related requirements. This serves as a guideline for applicants seeking regulatory approval for investigational medical devices.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
16MD.pdf
▶ Summary
This document is a checklist for obtaining a test license to import medical devices under the Medical Devices Rules, 2017. It includes specifications for Form MD-16 application, quality certificates, test protocols, and necessary undertakings. The checklist is intended for ensuring compliance with regulatory requirements for clinical investigations or demonstrations.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
14MD.pdf
▶ Summary
This document outlines the checklists and requirements for obtaining, endorsing, and retaining an import license for medical devices under the Medical Devices Rules, 2017. It details the necessary forms, supporting documents, and quality certifications required for importation and regulation of medical devices. The checklist supports applications related to new imports, additional devices, and retention of existing licenses.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
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12MD.pdf
▶ Summary
This document is a checklist for obtaining a test license to manufacture medical devices for clinical investigations, tests, evaluations, demonstrations, or training as per the Medical Devices Rules, 2017. It outlines the required documents and information, such as a covering letter, device description, and authorization for manufacturing and testing activities. The checklist ensures that appropriate facilities and personnel are available for these activities.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 16, 2025
|
pdf ↓ | ✗ Filtered |
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8MD.pdf
▶ Summary
This document is a detailed checklist for the grant, endorsement, and retention of loan licenses for manufacturing Class C and D medical devices under the Medical Devices Rules, 2017. It outlines the required documents and undertakings necessary for the application processes, focusing on compliance with regulatory standards. The document serves as guidance for manufacturers seeking compliance with the relevant medical device regulations.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
7MD.pdf
▶ Summary
This document provides a detailed checklist for the grant, endorsement, and retention of manufacturing licenses for Class C and Class D medical devices under the Medical Devices Rules, 2017. It outlines the necessary documentation and quality management system requirements needed for each of these licensing processes. Key items include applications, facility details, device master file components, and post-marketing surveillance reporting requirements.
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document |
CDSCO - Public Notices
Unknown
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—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
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Checklist-for-FSC-MD.pdf
▶ Summary
This document is a checklist for obtaining a Free Sale Certificate (FSC) for medical devices. It outlines the necessary paperwork and steps required, such as a cover letter, application form, fee receipt, a valid manufacturing license, and a legal undertaking from the manufacturer. This checklist guides applicants through the certification process for medical devices.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
Checklist-for-MSC-MD.pdf
▶ Summary
This document provides a checklist for obtaining a Market Standing Certificate (MSC) for medical devices. It outlines required documentation such as a cover letter, application form, manufacturing/import licenses, and sales details for the past three years. Additionally, a legal undertaking stating that no legal action has been taken against the manufacturer or importer must be included.
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document |
CDSCO - Public Notices
Unknown
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—
|
Dec 15, 2025
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pdf ↓ | ✗ Filtered |
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Checklist-for-NCC-MD.pdf
▶ Summary
The document is a checklist outlining the requirements for obtaining a Non Conviction Certificate (NCC) for medical devices. It includes necessary items like a cover letter, application for NCC, valid manufacturing/import license, and a legal undertaking from the manufacturer or importer. This checklist is presumably issued to guide applicants in the process of obtaining the certificate.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
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FAQ_GroupingGuidelines.pdf
▶ Summary
This document outlines the fee and documentation requirements for medical devices and in vitro diagnostics (IVDs) under the grouping guidelines of the Medical Devices Rules 2017. It details categorization criteria such as single, family, system, group, and IVD test kits along with associated fees and documentation processes. The information is particularly relevant for manufacturers and regulatory professionals dealing with medical devices subject to these specific rules.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Addendum-03-to-FAQ-on-Medical-Devices-Rules-2017.pdf
▶ Summary
This document is a Frequently Asked Questions (FAQ) guide about the regulation of medical devices by the Central Drugs Standard Control Organization (CDSCO) in India. It provides answers to common queries related to the Medical Devices Rules, 2017, including licensing requirements, importation regulations, and classification criteria. The document is intended to create public awareness and is not a legal or professional tool.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Addendum02faqmd.pdf
▶ Summary
This document is an FAQ addendum issued by the Central Drugs Standard Control Organization concerning medical devices regulations in India. It covers various topics such as re-import requirements, changes in firm constitution, and regulation of SEZ products under the Medical Devices Rules, 2017. Its purpose is to provide public awareness rather than serve as legal guidance.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
Addendum-0152.pdf
▶ Summary
This document is an addendum to the Frequently Asked Questions (FAQ) about Medical Devices Rules, issued by the Medical Devices Division of the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, India. It aims to clarify the regulations and requirements for biocompatibility testing, sterilization processes, labeling, and the licensing of medical devices. The information is intended to raise public awareness, though not for legal use.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
MDfAq24.pdf
▶ Summary
This document is a compilation of frequently asked questions regarding the Medical Devices Rules, 2017, issued by the Central Drugs Standard Control Organization (CDSCO) of the Ministry of Health and Family Welfare, India. It aims to create public awareness about medical device regulations, covering topics such as licensing requirements, regulatory authorities, and application procedures. It is explicitly noted that the information is for general awareness and not for legal purposes.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
FormMD26.pdf
▶ Summary
This document provides a specimen pro forma for submitting an application in Form MD-26 to obtain permission for the import or manufacture of medical devices which lack a predicate device. It is issued by the Medical Devices Division and includes relevant abbreviations and links to additional resources. The content appears to be a standard form-related document meant for regulatory submission purposes.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
FormMD22.pdf
▶ Summary
This document is a duly filled specimen pro forma for applications in Form MD-22 related to conducting clinical investigations of investigational medical devices. It appears to be issued by the Medical Devices Division of CDSCO. This document assists applicants in understanding the requirements for submission to the Central Licensing Authority.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
MDMD16Tooltip.pdf
▶ Summary
The document is a template form labeled "Form MD-16" designed for the submission of applications to obtain an Import Test license, indicated as a one-page document from the Medical Devices Division. It includes references to various specification standards and abbreviations commonly used in the context of medical device regulation. The document appears to aim at guiding applicants regarding the documentation needed for license applications.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
MDMD12Tooltip.pdf
▶ Summary
This document is a specimen pro forma for submitting an application in Form MD-12 to obtain a Manufacturing Test License, issued by the CDSCO Medical Devices Division. The document provides standard instructions and necessary abbreviations for filling out the application form. It is intended for applicants seeking licensing from the Central Licensing Authority.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
FormMD14n.pdf
▶ Summary
This document is a specimen pro forma for submitting applications to obtain an Import license for marketing medical devices, using Form MD-14. It provides guidelines from the Medical Devices Division under the Central Drugs Standard Control Organization (CDSCO). The document includes references to various useful links and abbreviations related to medical device licensing.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 16, 2025
|
pdf ↓ | ✗ Filtered |
|
FormMD8Specimen.pdf
▶ Summary
This document is a public notice from the Central Drugs Standard Control Organization (CDSCO) regarding the submission of applications in Form MD-8 for obtaining a manufacturing loan license to market medical devices. It includes a reference number and explains the related document structure and abbreviations. The notice provides important procedural information for stakeholders in the medical devices sector.
|
public notice |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
FormMD7n.pdf
▶ Summary
This document is a pro forma related to the submission of an application in Form MD-7 for obtaining a manufacturing license for marketing medical devices. It is a procedural template from the CDSCO designed to assist applicants in accurately completing their submissions for regulatory compliance. The document includes references to necessary documentation such as Device Master Files and instructions for use.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
RegulatoryMDR-2017.pdf
▶ Summary
This document outlines the regulatory procedures established under the Medical Devices Rules, 2017, by the Central Drugs Standard Control Organization of India for the development, licensing, and commercialization of medical devices. It highlights the various forms and associated licenses required for import, manufacturing, and clinical investigation of medical devices across different classes (A, B, C, D). The document also covers the procedures for import or manufacturing permission and the necessary quality compliance for using devices in clinical investigations on human subjects.
|
public notice |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
MD-MSC-NCCguidannce.pdf
▶ Summary
This is a guidance document issued by the Central Drugs Standard Control Organization (CDSCO) regarding the process for obtaining Market Standing Certificates (MSC) and Non-Conviction Certificates (NCC) for licensed medical devices in India. It outlines the purpose, scope, and submission procedures for manufacturers and importers to apply for these certificates, which are necessary for tender purposes. The document includes detailed application instructions and legal requirements.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Guidelines_Grouping_of_MDandIVD.pdf
▶ Summary
This is a guidance document issued by the Ministry of Health and Family Welfare, Government of India, on medical device regulations. It outlines the guidelines for licensing medical devices including application processes and grouping regulations under the Medical Devices Rules, 2017. The document provides detailed instructions and illustrations on how to categorize and license medical device families, systems, and in vitro diagnostic kits.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
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Essentialprinciples25.pdf
▶ Summary
This document is a public notice issued by the Ministry of Health and Family Welfare in India, relating to the guidelines for the Essential Principles for safety and performance of medical devices under the Medical Devices Rules, 2017. It discusses standards for safety and performance applicable to medical devices and outlines the responsibilities for manufacturers regarding device design, risk management, and adherence to safety principles. The notice was addressed to the Drugs Controller General (India) to upload the approved guidelines on the CDSCO website.
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public notice |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
fscguidancerev2024.pdf
▶ Summary
This document from the Medical Devices Division of the Central Drugs Standard Control Organization (CDSCO) is a guidance document for Indian medical device manufacturers. It outlines the process for applying for a Free Sale Certificate (FSC), which is necessary for exporting medical devices. The document includes submission requirements, necessary documentation, and reference guides for compliant applications.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
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pdf ↓ | ✗ Filtered |
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Guidance-document-for-Registration-of-Non-Notified-Medical-Devices..pdf
▶ Summary
This document provides guidance for manufacturers and importers on the registration process for non-notified medical devices as per the Central Drugs Standard Control Organization (CDSCO). It details steps for registration, documents required, and timelines for voluntary and mandatory registration of different classes of medical devices. The document serves as a comprehensive guide to ensure compliance with the ISO 13485 standard and other regulatory requirements by October 2023.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
mdGroupingFAQ.pdf
▶ Summary
This document is a guidance document issued by the Ministry of Health and Family Welfare, Government of India, focusing on the grouping guidelines for medical device applications under the Medical Devices Rules, 2017. It outlines the criteria and procedures for licensing medical devices when they are grouped as single items, families, systems, test kits, clusters, or groups. These guidelines aim to streamline the application process for licenses to import or manufacture medical devices in India.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Guidance1.pdf
▶ Summary
This is a guidance document issued by the Central Drugs Standard Control Organization (CDSCO) detailing the common submission format for manufacturing notified medical devices under the CLAA Scheme in India. It outlines the requirements and process for applying for a manufacturing license in Form-28 and provides specific guidance for various medical devices like cardiac stents and catheters. The document is intended to help streamline the submission process for manufacturers and regulators alike.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
med_div_-2016.pdf
▶ Summary
This document lists registration certificates issued for various medical devices and their manufacturing sites, along with the Indian authorized agents, between January 2016 and November 2016. The document includes details such as the names of Indian agents, manufacturers, device names, and registration validity dates. It primarily serves as a record-keeping document for regulatory purposes without any direct public notice or communication.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
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med_div_2015.pdf
▶ Summary
This document is a comprehensive list of registration certificates issued for medical devices, detailing the Indian agents, manufacturers, types of devices, registration numbers, dates of issue, and validity periods. It covers various medical devices approved between January 2015 and December 2015 by different Indian agents and manufacturers from across the globe.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
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med_div_2014.pdf
▶ Summary
This document lists the registration certificates issued for various medical devices, detailing the names of the Indian authorized agents, manufacturers, and specific devices, along with file numbers, registration certificate numbers, issuance dates, and validity periods. It appears to be an internal record or report detailing these certifications over time. The document offers a comprehensive overview and inventory of medical device certifications but lacks attributes of a public notice or advisory.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
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med_div_13.pdf
▶ Summary
This document from CDSCO lists registration certificates issued for medical devices manufactured by various companies between January and March 2013. It includes details such as the names of Indian agents, manufacturers, the devices, and registration validity periods. This serves as a public notice informing stakeholders about these approved medical devices and their associated details.
|
public notice |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
med_div_12.pdf
▶ Summary
This document contains a list of registration certificates issued for medical devices, detailing Indian agents, manufacturers, device names, file numbers, issue dates, and validity periods. It provides a comprehensive overview of approved medical devices and their registration statuses from January 2012 to December 2012. The document appears to be aimed at providing transparency and information regarding regulatory compliance for medical devices in India.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
med_div_11.pdf
▶ Summary
This document lists registration certificates issued for medical devices, along with details of manufacturers, Indian agents, types of devices, and certificate validity periods. It is a compilation of records from January 2011 to December 2013, covering various medical companies and products. The document appears to be intended for administrative or regulatory reference purposes.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
|
med_div_10.pdf
▶ Summary
This document is a public notice from CDSCO listing registration certificates issued for medical devices from January 2010 to December 2010. It includes details about the medical devices, their manufacturers, Indian authorized agents, and the validity of their registration certificates. It serves as an official record of certified devices and their compliance status for that period.
|
public notice |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
med_div_09.pdf
▶ Summary
This document lists registration certificates issued for various medical devices, along with details about the manufacturers, Indian agents, and their product specifications, valid from January to December 2009. It includes detailed information on the type of medical devices, associated companies, and each device's registration details such as file number and expiry date. The document serves as a record for regulatory purposes, possibly published by a regulatory body such as the CDSCO.
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document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 15, 2025
|
pdf ↓ | ✗ Filtered |
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med_div_06_08.pdf
▶ Summary
This document appears to be a list of medical device registrations, specifying the applicant and manufacturer details, alongside product names like cardiac stents and intraocular lenses. It includes a variety of devices from different manufacturers around the world. The document does not provide any specific actions, notices, or advisories beyond the listing itself.
|
document |
CDSCO - Public Notices
Unknown
|
—
|
Dec 16, 2025
|
pdf ↓ | ✗ Filtered |