Medical Device Testing Laboratories (MDTLs): Procedure

Last Updated on October 7, 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

Medical Device: Appellate Laboratory

Medical Devices: List of appellate laboratories

The government has notified six appellate laboratories for medical devices via the following notifications:

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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:

NABL

Medical Device Notifications

For various notifications about medical devices, click the below link:

Notifications – Medical Devices

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