| 1 |
2023.06.02_MDR_Final G.S.R. 409(E)_Amendment in Rule 18 and 19 for notifying State MDTL |
2023-Jun-02 |
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1157 KB |
| 2 |
MEDICAL DEVICES RULES, 2017 |
2023-Feb-15 |
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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 |
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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 |
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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 |
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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 |
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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 |
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766 KB |
| 8 |
2022.08.02_S.O. 3739(E)_Notification of Medical Devices Testing Officer for CMDTL |
2022-Aug-02 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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1585 KB |
| 15 |
2021.06.25_SO 2572(E)_Notification of 172 Drugs Inspectors as MDO |
2021-Jun-25 |
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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 |
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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 |
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12145 KB |
| 18 |
MDR_G.S.R. 102(E) dt_11.02.2020_Registration of certain medical devices |
2020-Feb-11 |
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1192 KB |
| 19 |
2020.02.11_S.O. 648(E)_ Medical Device Definition |
2020-Feb-11 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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1742 KB |
| 28 |
2018.07.11_S.O.3400 (E)_ Notification of Medical Device Testing Officers (MDTO) |
2018-Jul-11 |
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2098 KB |
| 29 |
2018.06.01_S.O.2237(E)_Notification of Central Medical Device Testing Laboratories |
2018-Jun-01 |
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1752 KB |
| 30 |
2018.03.23_S.O.1352(E)_ Banning of Diagnostic Tests for malaria_Sec. 26(A) |
2018-Mar-23 |
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1688 KB |
| 31 |
MDR_G.S.R. 76(E) dt_07.03.2018_ Notification of Medical Device Officers (MDO) |
2018-Mar-07 |
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1846 KB |
| 32 |
MDR_G.S.R. 78(E) dt_31.01.2017_Medical Devices Rules 2017 |
2017-Jan-31 |
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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 |
