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S.no | Title | Release Date | Download Pdf | Pdf Size |
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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 |