Updated list of Medical Device Testing Laboratories (MDTLs)

Download the updated list of Medical Device Testing Laboratories (MDTLs)

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Lab Testing Laboratory
Picture: Pixabay
Rakesh Dahiya

Last Updated on October 2, 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

CDSCO 29-11-2023 updated list of laboratories to conduct Performance evaluation of IVDs dated 29.11.23

DCGI-dt-07-03-2023-30-MDTLs-Updated-list-of-medical-devices-testing-laboratory-MDTL-registered-with-CDSCO-under-MDR-2017

DCGI-Notice-dt-17-08-2022-List-of-the-Certified-Medical-Device-Testing-Laboratory-under-MDR-2017-MDTLs

DCGI-Dt-05-05-2022-Updated-list-of-laboratories-for-conducting-Performance-evaluation-of-IVD-reagents-kit

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 LaboratoryCategory of medical deviceNotified vide Notification No.
1.The National Institute of Biologicals, NoidaIn-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 ReagentS.O. 2237(E) dated 01-06-2018
2.The Central Drugs Testing Laboratory, ChennaiCondomsS.O. 2237(E) dated 01-06-2018  
3.The Central Drugs Laboratory, KolkataSurgical Dressings, Surgical Cotton, Surgical Bandages, DisinfectantS.O. 2237(E) dated 01-06-2018  
4.The Regional Drugs Testing Laboratory (RDTL), GuwahatiDisposable Hypodermic Syringes, Disposable Hypodermic Needle, Disposable Perfusion Sets, I.V. CannulaeS.O. 2237(E) dated 01-06-2018
5.The Central Drugs Testing Laboratory, MumbaiIntra Uterine Devices (IUD) and Falope RingsS.O. 2237(E) dated 01-06-2018  
6.The Regional Drugs Testing Laboratory, ChandigarhDisposable 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:

NABL

Medical Device Notifications

For various notifications of medical devices, click below link:

Notifications – Medical Devices


Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana



Medical Device Testing Laboratories (MDTLs)

Commercial Testing Laboratories

Govt 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

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