Last Updated on January 2, 2024 by The Health Master
Medical Device Testing Laboratories (MDTLs)
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 Devices: List of appellate laboratories
The government has notified six appellate laboratories for medical devices via 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 the 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 a list of laboratory instruments. Click the below link to explore:
List of Laboratory Instruments for Pharma & Cosmetics Industry
NABL for Medical Devices
Click the below link for more details:
Medical Device Notifications
For various notifications about medical devices, click the below link:
Notifications – Medical Devices
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
FAQs on Medical Devices Rules, 2017
FAQs – on Blood Pressure Monitoring Devices
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