Central Drugs Standard Control Organization

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

Medical Devices Rules, 2017

S.no Title Release Date Download Pdf Pdf Size
1 2023.06.02_MDR_Final G.S.R. 409(E)_Amendment in Rule 18 and 19 for notifying State MDTL 2023-Jun-02 1157 KB
2 MEDICAL DEVICES RULES, 2017 2023-Feb-15 1692 KB
3 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 1012 KB
4 MDR_G.S.R. 754(E) dt_30.09.2022_Regulation of sale of medical devices via registration of premises under MDR 2017 2022-Sep-30 1384 KB
5 2022.09.28_S.O. 4574(E)_Designation of Government Analysts at RDTL Chandigarh as MDTO as per MDR 2017 2022-Sep-28 1220 KB
6 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
7 2022.08.10_S.O. 3758(E)_To authorize director incharge of CDL Kolkata for signing report of test of MD samples sent by Court o 2022-Aug-10 766 KB
8 2022.08.02_S.O. 3739(E)_Notification of Medical Devices Testing Officer for CMDTL 2022-Aug-02 1263 KB
9 MDR_G.S.R. 450(E) dt_15.06.2022_To amend Fourth Schedule wrt TSE or BSE certificate under MDR 2022-Jun-15 1385 KB
10 MDR_G.S.R. 356(E) dt_18.05.2022_Insert rule 43A for Suspension and cancellation of license in MDR 2017 2022-May-18 1337 KB
11 MDR_G.S.R. 174(E) dt_04.03.2022_Amendment of rule 36(3) MDR to include United Kingdom under MDR 2017 2022-Mar-04 1250 KB
12 MDR_G.S.R. 19(E) dt_18.01.2022_Amendment in rules 19B, 19C19D &19E of MDR 2017 2022-Jan-18 1557 KB
13 MDR_G.S.R. 918(E) dt_31.12.2021_Amendment of rule 46 of MDR for Unique Device Identification 2021-Dec-31 1355 KB
14 2021.09.02_S.O. 3596(E)_Notification of Amar Jyoti, Dilip Sarkar, Rinku Kalita & Arun Kr Das as MDTO 2021-Sep-02 1585 KB
15 2021.06.25_SO 2572(E)_Notification of 172 Drugs Inspectors as MDO 2021-Jun-25 1485 KB
16 MDR_G.S.R.224(E) dt_18.03.2019_Amendment in Environmental requirements for mfg. of Medical Devices_Annexure- A of the Fifth Schedule of MDR 2017 2021-Mar-18 304 KB
17 2020.10.21_S.O.3722 (E)_Extension of implementation date for S.O. 3721(E) dt 16.10.2019 for Ultrasound equipment under 3b(iv) of D&C Act 2020-Oct-21 12145 KB
18 MDR_G.S.R. 102(E) dt_11.02.2020_Registration of certain medical devices 2020-Feb-11 1192 KB
19 2020.02.11_S.O. 648(E)_ Medical Device Definition 2020-Feb-11 902 KB
20 MDR_G.S.R 787(E) dt_16.10.2019_Exemption of State & Central Govt testing labs from NABL accreditation for two years under MDR 2017 2019-Oct-16 303 KB
21 MDR_G.S.R.652(E) dt_13.09.2019_Amendment in Form MD-10 to replace the SLA as issuing authority with CLA in MDR 2017 2019-Sep-13 295 KB
22 MDR_G.S.R. 318(E) dt_18.04.2019_Amendment in Rule 91 & Second Schedule for fees of free sale certificate in the MDR 2017 2019-Apr-18 310 KB
23 2019.04.02_S.O. 1500(E)_ Notification of Organ Preservative solution as drug under Section 3(b)(iv) 2019-Apr-02 286 KB
24 2019.02.08_S.O. 775(E)_ Notification of certain medical devices (8 no's) under definition of drug_Section 3(b)(iv) 2019-Feb-08 265 KB
25 MDR_G.S.R. 30(E) dt_15.01.2019_Rule 3, Rule 59, 4th & 7th Schedules of MDR 2017 for insertion of e-IFU 2019-Jan-15 314 KB
26 2018.12.03_ S.O.5980_ Inclusion of four Medical devices in definition of drugs 2018-Dec-03 279 KB
27 MDR_GSR 729(E) dt_01.08.2018 _Amendment of Performance evaluation report of in-vitro diagnostic medical devices 2018-Aug-01 1742 KB
28 2018.07.11_S.O.3400 (E)_ Notification of Medical Device Testing Officers (MDTO) 2018-Jul-11 2098 KB
29 2018.06.01_S.O.2237(E)_Notification of Central Medical Device Testing Laboratories 2018-Jun-01 1752 KB
30 2018.03.23_S.O.1352(E)_ Banning of Diagnostic Tests for malaria_Sec. 26(A) 2018-Mar-23 1688 KB
31 MDR_G.S.R. 76(E) dt_07.03.2018_ Notification of Medical Device Officers (MDO) 2018-Mar-07 1846 KB
32 MDR_G.S.R. 78(E) dt_31.01.2017_Medical Devices Rules 2017 2017-Jan-31 3029 KB
33 2016.01.25_S.O. 237(E)_Notification for Ablation device 2016-Jan-25 51 KB
34 2005.10.06_S.O. 1468(E)_Notified Sterile Medical device 2005-Oct-06 29 KB