Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Key Notes on Revised Schedule M: Point No. 8 – Change Control - December 15, 2024
- Forms: All types for Hospital RMI - December 14, 2024
- Key Notes on Revised Schedule M: Point No. 7 – Product Recall - December 14, 2024
Last Updated on December 12, 2024 by The Health Master
Medical Device Testing Laboratories (MDTLs)
The Central Government periodically notifies Medical Device Testing Laboratories. For more details, click the below links:
List of MDTLs
DCGI-dt-10-12-2021-List-of-the-certified-Medical-Device-Testing-Laboratory-under-MDR-2017
DCGI-Notice-dt-27-08-2021-List-of-16-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-07-07-2021-List-of-14-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-08-03-2021-List-of-11-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-09-10-2020-List-of-10-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-03-10-2019-List-of-4-Testing-Laboratories-for-Medical-Devices-MDTLs
S.O.-2237E-dt-01-06-2018-Notification-of-5-Central-Medical-Device-Testing-Laboratories
Medical Device: Appellate Laboratory
Medical Device: List of appellate laboratories
Govt has notified 6 appellate laboratories for medical devices vide the following notifications:
List of appellate laboratories for medical devices:
Central Medical Device Testing Laboratory
for the purposes of:
- Testing and evaluation
- Functioning as an appellate laboratory; and
- To carry out any other function as may be specifically assigned to it by the Central Government in relation to the medical devices specified in column (3) of the said Table.
Table
| Sr. No. | Name of Laboratory | Category of medical device | Notified vide Notification No. |
| 1. | The National Institute of Biologicals, Noida | In-Vitro Diagnostics for human Immunodeficiency virus, Hepatitis B Surface Antigen and Hepatitis C Virus, Blood Grouping sera, Glucose Test Strip, Fully Automated Analyser Based Glucose Reagent | S.O. 2237(E) dated 01-06-2018 |
| 2. | The Central Drugs Testing Laboratory, Chennai | Condoms | S.O. 2237(E) dated 01-06-2018 |
| 3. | The Central Drugs Laboratory, Kolkata | Surgical Dressings, Surgical Cotton, Surgical Bandages, Disinfectant | S.O. 2237(E) dated 01-06-2018 |
| 4. | The Regional Drugs Testing Laboratory (RDTL), Guwahati | Disposable Hypodermic Syringes, Disposable Hypodermic Needle, Disposable Perfusion Sets, I.V. Cannulae | S.O. 2237(E) dated 01-06-2018 |
| 5. | The Central Drugs Testing Laboratory, Mumbai | Intra Uterine Devices (IUD) and Falope Rings | S.O. 2237(E) dated 01-06-2018 |
| 6. | The Regional Drugs Testing Laboratory, Chandigarh | Disposable Hypodermic Syringes, Disposable Hypodermic Needles, Disposable Perfusion Sets, Catheters, I.V. Cannulae, Scalp Vein Set, Ligatures, Sutures, Staplers, Surgical Dressing, Umbilical Tapes. | S.O. 4573(E) dated 28-09-2022 |
Click the below link to download the list of appellate laboratories for Medical Devices:
Bureau of Indian Standards (BIS) of Medical Devices
Bureau of Indian Standards (BIS) of Medical Devices, click below link:
DoP-Notice-dt-01-02-2022-List-of-standards-of-Bureau-of-Indian-Standards-BIS-for-Medical-Devices
List of Laboratory Instruments
We have provided list of laboratory instruments, click below link to explore:
List of Laboratory Instruments for Pharma & Cosmetics Industry
NABL for Medical Devices
Click below link for more details:
Medical Device Notifications
For various notifications of medical devices, click below link:
Notifications – Medical Devices
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Medical Device Testing Laboratories (MDTLs)
Commercial Testing Laboratories
NABL 164 released : Guidelines for Inter-laboratory comparison
NABL releases NABL 136: specific criteria for X-Ray equipment
NABL 126: Specific criteria for calibration of Medical Devices
NABL: List of NABL Accredited Testing Laboratories
Procedure to obtain license for manufacturing of Medical Devices
Procedure for registration of Medical Devices: CDSCO
Registration for sale of Medical Devices: Procedure and conditions
Latest Notifications: Medical Devices
Classifications of Medical Devices under the provisions of MDR 2017
Notified Bodies for Medical Devices
Forms: All types of Medical Devices
Schedules: All types of Medical Devices
FAQs on Medical Devices Rules, 2017
FAQs – on Blood Pressure Monitoring Devices
FAQs – on Blood Bags and its Testing
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
