Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Medical Device & Diagnostics

About Medical Devices

In India, all Medical Devices are regulated under the Drugs & Cosmetics Act, 1940 and Medical Devices Rules, 2017 made thereunder.
 
Medical Devices means -

All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―

•       diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
•       diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
•       investigation, replacement or modification or support of the anatomy or of a physiological process;
•       supporting or sustaining life;
•       disinfection of medical devices; and
•       control of conception.
 

Risk-based Classification -

Medical Devices are classified into four class based on the risk parameter as specified in Part I of the First Schedule of the Medical Devices Rules, 2017, as under:

    • Low risk - Class A;

    • Low moderate risk- Class B;

    • Moderate high risk- Class C;

    • High risk- Class D "

 

Functionalities

1.Grant of Certificate of Registration for a Notified Body for audit of Class A and Class B Medical Devices: A notified body accredited by National Accreditation Body( designated by Central Government) may apply in MD 1 to CLA for grant of registration certificate in MD 2.

2.Grant of Import Licence: The applicant shall make an application in MD-14 in sugam online portal for grant of import licence in MD-15 to import Medical Devices.

3.Grant of licence or loan licence to manufacture for sale or for distribution: The applicant shall make an application in MD-7 & MD-8 in sugam online portal for Grant of manufacturing Licence / Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D in MD-9 & MD-10.

4.Grant of test licence to manufacture for test, evaluation, clinical investigations, etc.:The applicant shall make an application in MD-12 in sugam online portal for licence in MD-13 to manufacture Medical Devices for purpose of clinical investigations, test, evaluation, examination, demonstration or training.

5.Grant of test licence to import for test, evaluation, clinical investigations, etc.: The applicant shall make an application in MD-16 in sugam online portal for licence in MD-17 to import Medical Devices for purpose of clinical investigations, test, evaluation, examination, demonstration or training.

6.Grant of license to Import investigational medical device by Government hospital or statutory medical institution for treatment of patient- Small quantity of investigational medical device, the import of which is not allowed, but approved in the country of origin, may be allowed to be imported by the Central Licensing Authority for treatment of a patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need, on an application made by a Medical Officer through the medical superintendent of a Government hospital or a statutory medical institution in Form MD-18

7.Permission to conduct clinical investigation of Investigational Medical Device:The applicant shall make an application in MD-22 in sugam online portal for grant of permission to conduct clinical investigation of investigational medical device in MD-23.

8.Permission to conduct clinical performance evaluation for new in vitro diagnostic medical device: The applicant shall make an application in MD-24 in sugam online portal for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device in MD-25

9.Permission to import or manufacture medical device which does not have its predicate device – The applicant shall make an application in MD 26 in sugam online portal after completion of its clinical investigation to the CLA for grant permission to import or manufacture medical device which does not have predicate medical device in Form MD-27.

10.Permission to import or manufacture new in vitro diagnostic medical device: The applicant shall make an application in MD-28 in sugam online portal for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device in MD-29.

11.Registration of Medical Device Testing Laboratory: The applicant shall make an application in MD-39 in sugam online portal for grant of registration in MD-40 to medical device (MD) testing laboratory for test or evaluation on behalf of manufacturer.

12.Preparation of Guidance and FAQ on key activities.

13.Processing of application for Issuance of Free Sale Certificate for domestic manufacturers Medical Devices.

14.Processing of application for Issuance of Market Standing Certificate and Non- Conviction for Medical Devices

15.Complaint, Not of Standard Quality (NSQ) Verification.

16.Updating the list as per the Classification of Medical Devices from time to time.

17.Post Approval Changes in respect of Medical Devices.

18.Constitution of MD experts committee.

19.Inspection of manufacturing site for compliance of QMS by CLA/SLA.

20.Capacity building activities of technical management.

21.Preparing and submitting replies of Parliament Questions/RTIs/Clarifications/NOCs/ Port office queries

22.Providing clarification to applicant on the regulatory status of products

Processes

Organogram

Medical Device Organogram

Guideline

S.no Title Release Date Download Pdf Pdf Size
1 Medical Device Alert dated 08 May 2023 2023-May-23 1842 KB
2 Medical Device Alert dated 29 Dec 2022 2023-Jan-04 916 KB
3 Medical Device Alert date 21 July 2022 2022-Jul-21 1328 KB
4 Medical Device Alert date 21 June 2022 2022-Jun-21 5121 KB
5 Medical Device Alert date 14 June 2022 2022-Jun-14 955 KB
6 Medical Devices Alert 8 November 2021 2021-Nov-08 2370 KB
7 Medical Devices Alert on MiniMed 620G Insulin Pump/Pump Kits & MiniMed 640G Insulin Pump/Pump kit of India Medtronic Ltd 2021-Oct-11 1976 KB
8 Alert_FSN-Medtronic Heartware HVAD 2021-Sep-17 285 KB
9 Medical Devices alert for Ventilator of Philips August 2021 2021-Aug-09 659 KB
10 Medical Devices alert july 2019 2019-Jul-02 567 kb
11 Medical Device Alert Dated 20.05.2019 2019-May-20 88 KB
12 NOC update list of Medical Devices 2013 2018-Oct-10 95 KB
13 NOC update list of Medical Devices 2018 2018-Oct-10 225 KB
14 NOC update list of Medical Devices 2017 2018-Oct-10 914 KB
15 NOC update list of Medical Devices 2016 2018-Oct-10 138 KB
16 NOC update list of Medical Devices 2015 2018-Oct-10 162 KB
17 NOC of Medical Devices 2011 2018-Oct-10 91 KB
18 NOC Updated list of Medical Devices 2012 2018-Oct-10 112 KB
19 NOC update list of Medical Devices 2014 2018-Oct-10 79 KB
20 List of Clarifications/NOCs Issue from 2011- 2018 2018-Aug-03 1280 KB
21 List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of MAY, 2018 2018-Jun-11 390KB
22 Drug Alert for the month of April,2018 2018-Jun-01 80KB
23 Destroy of the product demaged due to fire 2017-Jul-04 57 KB
24 MEDICAL DEVICE ALERT FOR " Absorb Bioresorbale Vascular Scaffold BVS and Absorb GT1 Bioresorbale Vascular Scaffold BVS 2017-Jun-28 1274 KB
25 Medical Devices alert 02.06.2017 2017-Jun-02 1125 KB
26 MEDICAL DEVICE ALERT FOR " Beacon Tip Torcon NB Advantage Catheter 2017-Jun-02 1125 KB
27 Medical Devices alert 13.04.2017 2017-Apr-13 1048 KB
28 Medical Devices alert 07.04.2017 2017-Apr-07 1134 KB
29 Non-conviction Certificate 2017-Feb-17 6 kb
30 Medical Devices alert 21.10.2016 2016-Oct-21 868 KB
31 Confidence Spinal Cement System 2014-Jan-15 241kb
32 MEDICAL DEVICE ALERT FOR PRODUCT "HT Connect Peripheral Guidewire 2014-Jan-04 241 KB
33 LPS Lower Extremity Dovetail IntercalaryComponent 2013-Dec-11 238kb
34 Cancellous Bone Screws (A Component of the Hip System) 2013-Dec-11 209kb
35 HT Connect Peripheral Guidewire 2013-Dec-10 241kb
36 ECHELON Endoscopic Liner Cutter Reloads Black(ECR60T) 2013-Dec-10 268kb
37 ONYX Liquid Embolic System 2013-Dec-10 266kb
38 ASR XL Acetabular System & DePuy ASR Hip Resurfacing System 2013-Dec-09 266kb
S.no Title Release Date Download Pdf Pdf Size
1 Seminar on Strengthening Medical Device Licence Holders on Post-Market Safety Surveillance Practices in India and Medical Device Stakeholders Consultation Meeting PGIMER Chandigarh on 3rd September 2024 2024-Jul-26 1515 KB
2 Applicant User Manual For Form MD-41 2022-Nov-18 1335 KB
3 FSCA Form 2019-Apr-09 404KB
4 Medical Device Adverse Event Reporting Form 2019-Apr-09 460 KB
5 Frequently Asked Questions on Medical Device Rule 2017 2018-Dec-28 244 KB
6 Guidance Documents on Free Sale Certificate of Notified Medical Devices in India 2018-Nov-06 446KB
7 Guidance on Performance Evaluation of In-vitro Diagnostic Medical Devices 2018-Aug-10 144 KB
8 Grant of additional products & certificates like i.e. Market standing certificate, Non-conviction certificate and performance certificate etc. w.r.t. Medical Devices and In-vitro Diagnostics 2018-Aug-08 408 KB
9 The National Coordination Centre (NCC)-Materiovigilance Programme of India (MvPI) has released Draft Guidance Document for Medical Devices. This is a unique document which covers all the relevant information related to Medical Device under one umbrella. Guidance Document is now available to seek stakeholder’s comments till 01/09/2018 (30 calendar days) 2018-Aug-06 9,461,760 KB
10 Quality Control testing of viral load monitoring kits for HIV, HCV and HBV-Reg 2018-Jul-24 639 KB
11 Workshop for MD & IVD manufacturers on 19.02.2018 2018-Feb-19 110 KB
12 FAQ_IVD_MDR-2018 2018-Feb-17 1037 KB
13 List of Clarifications/NOCs Issue from 2011- 2018 2018-Jan-16 2800 KB
14 TR6 Challan 2017-Feb-17 120 KB
15 Additional Clarification with Regard to Control of Various Medical Devices (20.03.2008) 2017-Feb-17 147 KB
16 ALLERGEN PRODUCTS CHECKLIST FOR VERIFICATION OF INFORMATION TO BE PROVIDED BY APPLICATION AT CDSCO 2017-Feb-17 89 KB
17 Form 40 2017-Feb-17 112 KB
18 Form 8 2017-Feb-17 108 KB
19 Report of the committee to examine the issues relating to the essentiality of coronary stents 2017-Feb-17 8281 KB
20 Regulation of Medical Device covered Under Notified Medical Device 2017-Feb-17 74 KB
21 Grouping Guidelines for Medical Device Applications 2017-Feb-17 1984 KB
22 Guidance document on application for grant of licence in Form-28 for manufacture of Medical Devices in India Under CLAA Scheme 2017-Feb-17 701 KB
23 Guidance document on common submission format for Manufacture of Medical Devices (Form-28) Under CLAA Scheme 2017-Feb-17 238 KB
24 Guidance document on common Submission Format for Registration(Form-41)(Excluding Notified IVD's), Import Licence(Form 10)(Excluding IVD's) and Manufacture of Medical Devices (Form- 28) Under CLAA Scheme 2017-Feb-17 283 KB
25 Proposal invited for designation of Central Medical Device testing lab for Medical devices including In-Vitro Diagnostic medical Device under Medical Devices Rules, 2017 2017-Feb-17 638 KB
26 Guidelines for Import and Manufacture of Medical Devices (01.03.2006 2017-Feb-17 170 KB
27 Guidelines on Essential Principles for safety and performance of Medical Devices 2017-Feb-17 8264 KB
28 Power of Attorney 2017-Feb-17 122 KB
29 Performance Certificate 2017-Feb-17 332 KB
30 Orthopedics MDAC 2017-Feb-17 193 KB
31 MEDICAL DEVICE (TEST LICENSE) 2017-Feb-17 169 KB
32 MEDICAL DEVICE REGISTRATION CERTIFICATE 2017-Feb-17 133 KB
33 MEDICAL DEVICE (CLINICAL TRIAL) 2017-Feb-17 115 KB
34 CHECKLIST/PERFORMA TO BE PROVIDED FOR VERIFICATION OF INFORMATION ON ALLERGEN IVD BY APPLICANT FOR GRANT OF FORM 10 2017-Feb-17 89 KB
35 Import Registration Certificates for Medical Devices issued 2017 2017-Feb-17 138 KB
36 List of Clarifications/NOCs Issue from 2011- Oct 2017 2017-Feb-17 901 KB
37 Medical Device Adverse Event reporting form 2017-Feb-17 1655 KB
38 Market Standing Certificate 2017-Feb-17 6 KB
39 List of Notified Medical Devices 2017-Feb-17 85 KB
40 List of Licensed indigenous Manufacturers of Medical Devices Year 2017 2017-Feb-17 1557 KB
41 Clarification For Import of Freezing Bags Transfer Set 2017-Feb-17 128 KB
42 Clarification for Import of Non-Notified Medical Devices 2017-Feb-17 212 KB
43 Clarification for Import of Pre filled Syringes Components 2017-Feb-17 282 KB
44 Clarification for Import of Raw Materials in bulk form in Rolls/Bundle for Manufacture of Finished Product (Sutures) 2017-Feb-17 258 KB
45 Clarification on Guidelines for Import & Manufacture of Medical Device 2017-Feb-17 195 KB
46 Clarification on Regulation of Stapler (Staples) 2017-Feb-17 54 KB
47 Classification of Medical devices and in Vitro diagnostic Medical devices under the provisions of the Medical Devices Rules 2017 2017-Feb-17 4147 KB
48 Non- Compliance observed During Review Process of application for Registration & Import Licenses of Medical Devices 2016-Feb-23 198 KB
49 Acceptance Criteria for test and Examination of Blood Glucose Test Trips and Analyzer based glucose reagent 2016-Feb-17 55 KB
50 Form 12A 2016-Feb-17 97 KB
51 Form 12AA 2016-Feb-17 108 KB
52 Form 27 2016-Feb-17 171 KB
53 Guidance Document on Common Submission Format for Import License in Form-10 of Notified Medical Devices in India (01.01.2013) 2016-Feb-17 467 KB
54 Import Registration Certificates for Medical Devices issued 2016 2016-Feb-17 872 KB
55 List of Licensed indigenous Manufacturers of Medical Devices Year 2016 2016-Feb-17 996 KB
56 MDAC - CARDIOVASCULAR 2016-Feb-17 121 KB
57 MDAC - DENTAL 2016-Feb-17 52 KB
58 MDAC - ORTHOPAEDIC 2016-Feb-17 321 KB
59 MDAC - REPRODUCTIVE & UROLOGY 2016-Feb-17 47 KB
60 Medical Device Licensed Manufacturing units in Various State of India 2016-Feb-17 403 KB
61 Miscellaneous MDAC 2016-Feb-17 69 KB
62 Minutes of the Meeting held on 05.12.2015 2015-Dec-05 264 KB
63 Revised Schedule MIII For Finalized by sub committee of DTAB 2015-Aug-19 525 KB
64 Revised Pre-Screening checklist for acceptability of application of Medical Device and Invitro Diagnostic w.e.f 01.07.2015 2015-Jul-21 559 KB
65 REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS OF MEDICAL DEVICES IN INDIA 2015-Feb-18 2671 KB
66 Form 9 2015-Feb-17 109 KB
67 Import Registration Certificates for Medical Devices issued 2015 2015-Feb-17 1322 KB
68 List of Licensed indigenous Manufacturers of Medical Devices Year 2015 2015-Feb-17 879 KB
69 Frequently asked Question on registration and import of medical devices in India 2015-Feb-10 808 KB
70 Form 12 2014-Jun-30 104 KB
71 List of Licensed indigenous Manufacturers of Medical Devices Year 2014 2014-Feb-17 468 KB
72 Import Registration Certificates for Medical Devices issued 2014 2014-Feb-17 1214 KB
73 Dental MDAC 2014-Feb-17 341 KB
74 Guidance Document on Application for Grant of License in Form-28 for Manufacture of Medical Devices in India Under CLAA Scheme(01.01.2013) 2014-Feb-17 809 KB
75 Form 44 2014-Feb-10 109 KB
76 Guidance Document on Common Submission Format for Registration/ Re-Registration of Notified Medical Devices in India (01.01.2013) 2013-Dec-17 777 KB
77 Cardiovascular MDAC 2013-Feb-17 615 KB
78 Import Registration Certificates for Medical Devices issued 2013 2013-Feb-17 940 KB
79 List of Licensed indigenous Manufacturers of Medical Devices Year 2013 2013-Feb-17 284 KB
80 Import Registration Certificates for Medical Devices issued 2012 2012-Feb-17 685 KB
81 List of Licensed indigenous Manufacturers of Medical Devices Year 2012 2012-Feb-17 199 KB
82 Import Registration Certificates for Medical Devices issued 2011 2011-Feb-17 580 KB
83 List of Licensed indigenous Manufacturers of Medical Devices Year 2011 2011-Feb-17 139 KB
84 List of Licensed indigenous Manufacturers of Medical Devices Year 2010 2010-Feb-17 184 KB
85 Import Registration Certificates for Medical Devices issued 2010 2010-Feb-17 871 KB
86 Import Registration Certificates for Medical Devices issued 2009 2009-Feb-17 441 KB
87 List of Licensed indigenous Manufacturers of Medical Devices Year 2009 2009-Feb-17 221 KB
88 Import Registration Certificates for Medical Devices issued 2006-2008 2008-Feb-17 807 KB
S.no Title Release Date Download Pdf Pdf Size
1 Circular- Testing and evaluaion of Medical Devices/ In-Vitro Diagnostics by Medical Devices Testing Laboratory in the Country 2024-May-29 429 KB
2 Notice to All stakeholders for Strengthening of Private Medical Device Testing Laboratory 2024-Apr-03 388 KB
3 Online application for Neutral Code for manufacturing of Medical Devices for export purpose 2024-Feb-12 305 KB
4 Launching of National Single Window System (NSWS) Portal 2024-Jan-01 3669 KB
5 Regulation of all Class C & D Medical Devices Under Licensing regime, w.e,f 01.10.2023 as per GSR102E dated 11.02.2020 2023-Oct-12 385 KB
6 Clarification on the Circular no. 29/Misc/03/2023-DC(344) dated 12.10.2023 2023-Oct-12 22 KB
7 List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017 2023-Sep-15 1635 KB
8 Circular for Licensing of Class C D medical devices dated 12.04.2023 2023-Apr-12 310 KB
9 List of Notified Bodies registered with CDSCO under MDR, 2017 2023-Apr-03 830 KB
10 Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer 2022-Dec-22 412 KB
11 Notice regarding implementation of gazette notification vide GSR 754(E) dated 30.09.2022 2022-Oct-21 290 KB
12 Classification of Medical Device pertaining to Oncology under the provisions of Medical Devices Rules, 2017 2022-Oct-11 817 KB
13 Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017 2022-Oct-10 764 KB
14 Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022, as per G.S.R. 102(E) dt 11.02.2020 2022-Sep-30 401 KB
15 Strengthening of Medical Products Safety Surveillance System in North Eastern States of India on October 19 2022 at Government Pharmacy College Sajong Sikkim 2022-Sep-29 1476 KB
16 Classification of Medical Device Pertaining to non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments for general use intended to be used in various general surgical procedures 2022-Sep-09 524 KB
17 List of the Certified Medical Device Testing Laboratory under MDR, 2017 2022-Aug-17 5938 KB
18 Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devcies Rules 2017 2022-Aug-04 852 KB
19 Notice dated July 11 2022 2022-Jul-11 370 KB
20 Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of Medical Devices Rules 2017 2022-Jun-03 529 KB
21 Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017 2022-Mar-16 813 KB
22 Regulation of CT scan equipment_All Implantable Devices_MRI equipment etc. as Drugs with effect from April 1st 2021 2021-Nov-03 246 KB
23 Classification of Medical Device pertaining to Neurological under the provisions of Medical Devices Rules, 2017 2021-Sep-28 367 KB
24 Registration and Labelling requirements of Medical Devices 2021-Sep-28 366 KB
25 Classification of Medical Device pertaining to Gastroenterology under the provisions of Medical Devices Rules, 2017 2021-Sep-27 929 KB
26 Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of Medical Devices 2021-Sep-21 513 KB
27 Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of Medical Devices Rules 2017 2021-Sep-13 744 KB
28 Classification of Medical Device pertaining to Operation Theatre under the provisions of Medical Devices Rules 2017 2021-Sep-13 804 KB
29 Classification of Medical Device pertaining to Pain Management under the provisions of Medical Devices Rules 2017 2021-Sep-13 334 KB
30 Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of Medical Devices Rules 2017 2021-Sep-13 674 KB
31 Classification of Medical Device pertaining to Software under the provisions of Medical Devices Rules 2017 2021-Sep-13 698 KB
32 The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded by BIS for ready reference 2021-Sep-07 665 KB
33 List of Medical devices testing Laboratory for carry out test or evaluation of Medical device on behalf of Manufacturer registered with CDSCO under MDR 2021-Aug-27 3982 KB
34 Classification of Medical Device Pertaining to Pediatrics and Neonatology Under the provision of Medical Devices Rules 2017 2021-Aug-23 1120 KB
35 Classification of Medical Device Pertaining to Urology Under the provision of Medical Devices Rules 2017 2021-Aug-23 955 KB
36 Classification of Medical Devices Pertaining to Ophthalmology under the Provisions of Medical Devices Rules 2017 2021-Aug-09 889 KB
37 Classification of Medical Device Pertaining to Radiotherapy under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021 2021-Aug-06 606 KB
38 Classification of Medical Device Pertaining to Respiratory Under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021 2021-Aug-06 628 KB
39 Classification of Medical Devices Pertaining to ENT under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021 2021-Aug-06 601 KB
40 Classification of Medical Device Pertaining to Physical Support under the Provisions of Medical Devcies Rules 2017 2021-Jul-26 618 KB
41 Classification of Medical Device Pertaining to Interventional Radiology under the Provisions of Medical Devcies Rules 2017 2021-Jul-26 432 KB
42 Classification of Medical Device Pertaining to Dermatological and Plastic Surgery under the Provisions of Medical Devcies Rules 2017 2021-Jul-26 256 kB
43 Classification of medical device pertaining to Cardiovascular under the provisions of Medical Devices Rules 2017 2021-Jul-26 523 KB
44 Classification of medical devices pertaining of Anesthesiology under the provision of Medical Devices Rules 2017 2021-Jul-12 200 KB
45 List of medical devices testing laboratory for carry out test or evaluation of medical device on behalf of manufacturer with CDSCO under MDR 2017 2021-Jul-07 4025 KB
46 Regulation of CT Scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st 2021 2021-Apr-18 138 KB
47 Regulation of Blood Glucose monitors Blood pressure monitors Nebulizers and Thermometers as drugs with effect from Jan 1st 2021 2020-Dec-28 334 KB
48 Notice regarding List of medical devices testing Laboratory 2020-Oct-09 2927 KB
49 Notice regarding classification of non notified medical devices1 2020-Sep-03 12557 KB
50 Online Application for Free Sale certificate Market standing certificate and Non-conviction certificate of Notified Medical Devices 2020-Sep-03 301 KB
51 Requirement of fees for change in address of authorized agent without change in constitution as post approval Change under MDR 2017 2020-Aug-31 362 KB
52 Submission of notarized/apostilled documents for import of medical device and in-vitro diagnostic kits in view of Covid-19 2020-Aug-31 343 KB
53 Clarification regarding import of diagnostic kits/ reagents for Research use only ROU for academic research purpose 2020-Jun-19 368 KB
54 Submission of notarized/apostilled document for import and registration of medical devices in view of covid-19 2020-Apr-23 307 KB
55 Strengthening of Materiovigilance Programme of India (MvPI) in the country 2019-Nov-26 56 KB
56 Processing of application for product approved as medical device in the country of origin, but covered under the definition of drug in the country-reg 2019-Nov-15 289 KB
57 Notice regarding equipments which are non notified but associated with notified devices 2019-Nov-13 226 KB
58 Notice regarding all implantable devices 2019-Nov-08 252 KB
59 Notice regarding environmental conditions for equipments 2019-Nov-08 235 KB
60 Notice regarding exemption of drugs Sale License 2019-Nov-08 235 KB
61 Notice regarding Notification to notify all the medical device under sub-section (b) of Section 3 of th Drugs and Cosmetics Act 1940 to regulate them as per the provisions of the Act and Medical Devices Rules 2017 2019-Oct-18 1962 KB
62 Constitution of Medical Devices Technical advisory group (MDTAG) to advise CDSCO on matter related to regulation of medical devices-Reg 2019-Jul-22 650 KB
63 Classification of Newly Notified Medical Devices to be updated with Classification list of Medical Devices and IVDs 2019-May-15 2021 KB
64 Formula for grant of Compensation to the patients who were implanted with ASR Hip and Constitution of the state Level Committee 2018-Nov-30 2586 KB
65 Health Ministry approves compensation formula for Hip implant cases 2018-Nov-29 157 KB
66 Application form for Compensation-DePuy_Johnson 2018-Nov-15 118 KB
67 To provide guidance and advertisement for compensation to patients implanted with ASR Hip Implants 2018-Nov-08 439 KB
68 Advertisement of ADI 2018-Sep-30 425 KB
69 Constitution of State level Committee Regarding the Faulty ASR HIP Implant manufatured by M/s DePuy International Ltd U K 2018-Sep-28 352 KB
70 Office Order 2018-May-11 265KB
71 Office Order 2018-May-01 245KB
72 Office Order regarding Public Relations Office at CDSCO (HQ) 2018-Apr-23 245KB
73 Grouping Guidelines for Medical Devices Applications 2018-Mar-16 1,984kb
74 Office Order regarding Setting up of Public Relation Office at CDSCO (HQ) dated 07.3.2018 2018-Mar-07 310KB
75 Office Corrigendum regarding Drugs Inspector's transfers in CDSCO 2018-Feb-20 204KB
76 Order regarding Drugs Inspector's/Technical officer's transfers 2018-Feb-20 931KB
77 Report of the Expert Committee to address the Issue of Faulty ASR™ Hip Implants (Dr. Arun Kumar Aggarwal, The Chairman of the Expert Committee) 2018-Feb-19 34851 KB
78 Office order regarding Grievance Redressal in CDSCO (HQ) 2018-Feb-13 304KB
79 Notice regarding application were called for engagement of Research Scientist medical Device and Diagnostic on contractual basis under CDSCO H/Q 2018-Jan-23 606KB
80 Office Memorandum regarding Filling up the post of DIs(Medical Devices) in CDSCO on deputation basis 2018-Jan-22 823KB
81 Office order regarding appointed to offciate on ad-hoc basis on the post of ADC(I) 2018-Jan-22 875KB
82 NOTICE - regarding Draft guidance documents on essential principles for safety and performance of medical devices as per medical devices rules 2017 2018-Jan-01 1.16MB
83 Office order regarding SUGAM Portal of CDSCO 2017-Dec-11 180KB
84 Office order regarding appointment of CPIO and Applellate Authority u/s 5 of RTI 2005 for RDTL Chandigarh 2017-Dec-05 308kb
85 Notice Regarding Classification of Medical devices and in Vitro diagnostic Medical devices under the provisions of the Medical Devices Rules 2017 2017-Nov-01 4,147 KB
86 Office Memorandum regarding clarification for dealing with impoted consignments of Medical Devices and IVDs held at the port offices 2017-Oct-31 665KB
87 NOTICE regarding not of Standard Quality of Mediclone D 2017-Sep-15 59.9KB
88 NOTICE regarding Not of Standard Quality Combipack ABD 2017-Sep-15 72.8KB
89 NOTICE - regarding Setting up of GST helpdesk in CDSCO (HQ) 2017-Jul-17 182KB
90 NOTICE - regarding availability of essential mediines following implementation of GST 2017-Jul-13 637KB
91 corrigendum with respect to revised specification/criteria of acceptance for quality test for Ant-HCV Rapid Kit 2017-Jul-12 41.9KB
92 Notice Order regarding draft classification of Medical Devices and IVDs 2017-Jun-29 1.83MB
93 Notice Order regarding Streamlining the regulatory procedures 2017-Jun-27 212KB
94 Notice Order regarding address the grievances/ appeals 2017-Jun-22 642kb
95 Notice Order regarding Oseltamivir and Zanamivir 2017-Jun-22 1.14MB
96 Notice regarding Draft SOP for handling of NSQ samples 2017-Jun-13 5.57KB
97 Notice regarding Online application for registration of Notified Body through SUGAM Portal under medical Devices Rules 2017 2017-May-30 279KB
98 Office Memorandum permission to affix the sticker indicating date of manufacture and Date of expiry with respect of Medical Devices under the provision of Drugs and Cosmetic Rules 2017-May-04 60.1KB
99 NOTICE - regarding testing of Notified Diagnostics kits for hepatiitis Kit at ILBS New Delhi 2017-Apr-24 37.5KB
100 Notice regarding Meeting for the registration of notified body through online portal 2017-Apr-07 542KB
101 Notice regarding Issue of Updating the Schedule H of the Drugs and Cosmetics Rules 1945 2017-Mar-31 250KB
102 Office memorandum regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse 2017-Mar-30 287KB
103 Public Notice regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse 2017-Mar-30 213KB
104 Notice regarding Regulatory approvals relating to combination products for HIV Hepatitis B&C which are recommended for Concomitant use by WHO 2017-Mar-20 432KB
105 Notice regarding Finalization of audit fee of Notified Bodies under Medical Devices Rules,2017 2017-Feb-17 9728 KB
106 Notice regarding Streamline the grievance 2017-Feb-02 362KB
107 Notice regarding Medical Devices Rules,2017 Notification No. 78E 2017-Feb-02 23.0KB
108 List of clarifications and NOC issued from 2011 to 2017 2017-Jan-02 901kb
109 Extending the validity of Free Sale certificate for notified medical devices 2016-Apr-21 650KB
110 Notice regarding Launching of Online portal SUGAm for import and registration of Medical Devices and Diagnostics 2016-Mar-04 673KB
111 Acceptance Criteria for test and Examination of Blood Glucose Test Trips and Analyzer based glucose reagen 2016-Feb-16 54KB
112 Clarification for import of in Bulk form in Sutures 2015-Dec-08 258kb
113 Latter to All state/UT Drugs Controllers regarding Availabilty of diagnostic Kits, Drugs used for swine Flue 2015-Feb-14 294KB
114 Office Order dated 09.07.2014 Clarification for regulation of Medical devices under the provision of Drugs and Cosmetics Acts and Rules 2014-Jul-09 437KB
115 Clarification reg NOC to import of diagnostics kit or reagent for ROU dated 13.07.2012 2012-Jul-13 201 KB
116 Regulation of import and manufacture of certain medical devices covered under the Categories of notified Medical devices 2012-Mar-05 74 KB
117 GENERAL ORDER 2012-Feb-17 140 KB
118 MISCELLANEOUS ORDER 2012-Feb-17 118 KB
119 ORTHOPAEDIC ORDER 2012-Feb-17 127 KB
120 REPRODUCTIVE & UROLOGY ORDER 2012-Feb-17 123 KB
121 Clarification for import of pre-filled syringe 2011-Nov-07 282kb
122 Clarification on regulation of staplers 2011-Oct-04 54kb
123 MDAC Cardiovascular order dated 10 May 2011 2011-May-10 129 KB
124 MDAC of General Expert Pool 2011-May-10 140 KB
125 MDAC Miscellaneous Devices 2011-May-10 118 KB
126 MDAC of Ophthalmic 2011-May-10 126 KB
127 MDAC Dental 2011-May-10 119 KB
128 MDAC of Orthopedic 2011-May-10 127 KB
129 MDAC of Reporductive and Urology 2011-May-10 123 KB
130 DENTAL ORDER 2011-Feb-17 119 KB
131 CARDIOVASCULAR ORDER 2011-Feb-17 129 KB
132 OPHTHALMIC ORDER 2011-Feb-17 126 KB
133 List of Notified Medical devices 2010-Apr-20 85 KB
S.no Title Release Date Download Pdf Pdf Size
1 02.06. 2023 G.S.R 409(E) Medical Devices 2023-Jun-02 1157 KB
2 MDR_G.S.R. 777(E) dt_14.10.2022_exemption of non sterile and non measuring Class A medical devices from licensing regime 2022-Oct-14 1102 KB
3 G.S.R. 777(E) 14 Oct 2022 Final notification for exemption of non sterile and non measuring Class A medical devices from licensing regime 2022-Oct-14 1020 KB
4 GSR 754 (E) 30-09-2022 sale of medical device retail and wholesale 2022-Sep-30 1348 KB
5 2022.09.28_S.O._4573(E)_Notification for designation of RDTL Chandigarh also as CMDTL as per MDR 2017 2022-Sep-28 1291 KB
6 2022.09.20_Draft_GSR 710(E)_Exemption of certain Class A medical device from licensing regime 2022-Sep-20 1300 KB
7 2022.08.02_S.O. 3739(E)_Notification of Medical Devices Testing Officer for CMDTL 2022-Aug-02 1126 KB
8 2022.06.15_Final GSR 450(E)_To amend Fourth Schedule wrt TSE or BSE certificate under MDR 2022-Jun-15 1348 KB
9 2022.05.18_Final GSR 356(E)_Insert rule 43A for Suspension and cancellation of license in MDR 2017 2022-May-18 1137 KB
10 2022.02.09_Draft GSR 104(E)_Regulation of sale of medical devices via registration of premises under MDR, 2017 2022-Feb-09 1520 KB
11 2022.02.09_S.O. 553(E)_ Stockpiling of new drug under phase 3 of clinical trial_NDCTR,2019 2022-Feb-09 1106 KB
12 2022.01.18_Final GSR 19(E)_Amendment in rules 19B, 19C,19D &19E of MDR 2017 2022-Jan-18 1557 KB
13 2021.12.31_Final GSR 918(E)_Amendment of rnule 46 of MDR for Unique Device Identification 2021-Dec-31 1355 KB
14 S.O. 3722(E) dated 21.10.202 2020-Oct-21 1215 KB
15 S.O. 648(E) dated 11.02.2020_ Medical Device Definition 2020-Feb-11 902 KB
16 G.S.R. 102(E)_dated 11.02.2020_ Registration of certain medical devices 2020-Feb-11 1192 KB
17 2019.10.18_G.S.R. 797(E)_Registration of Certain Medical Devices_chapter-IIIA 2019-Oct-18 370 KB
18 2019.03.18 Final G.S.R.224(E) Amendment in Environmental requirements for mfg. of Medical Devices Annexure- A of the Fifth Schedule of MDR, 2017 2019-Mar-18 303 KB
19 S.O.5980(E)-03-12-2018 2018-Dec-03 279 KB
20 S.O. 2237(E) 2018-Jun-01 1,752KB
21 6th October 2005 (SO 1468(E) 2017-Feb-17 69 KB
22 17th March 1989 GSR 365 (E) 2017-Feb-17 166 KB
23 27th August 2002 GSR 601 (E) 2017-Feb-17 217 KB
24 24th October 2013 (GSR 703 (E) 2017-Feb-17 558 KB
25 S.O. 2237(E)_Notification on Central Medical Device Testing Laboratory under MDR 2017 2017-Feb-17 1752 KB
26 7th October 2005 (GSR 627 (E) 2017-Feb-17 66 KB
27 Medical Device Rule 2017 - GSR 78(E) Dated- 31.01.2017 2017-Jan-31 3029 KB
28 GSR 640 (E) dated 29.06.2016 regarding Schedule - MIII - Requirement of QMS for Medical Devices 2016-Jun-17 484 KB
29 G.S.R 690(E) 2014-Sep-25 222kb
30 S.G 3793(E) 2013-Dec-23 135kb
31 G.S.R 627(E) 2005-Oct-07 66kb
32 S.O 1468(E) 2005-Oct-06 69kb
33 GSR_601_E_27-08-2002 2002-Aug-27 1336 KB
34 G.S.R. 600(E) 2002-Aug-07 1336kb
35 G.S.R. 365(E) 1989-Jun-17 166kb