Procedure to obtain license for Commercial Testing Laboratories

How to obtain License for Commercial Testing Laboratories

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Laboratory
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Last Updated on December 8, 2021 by The Health Master

Procedure to obtain license for Commercial Testing Laboratories

Also read the article: Suggestion: G.S.R No. 223 (E) 18-03-2019, Form 39(A)

How to obtain License for Commercial Testing Laboratories

We have provided the procedure to obtain license for commercial testing laboratories, documents required, application form, fee required, conditions of licenses and procedure for retention fee etc.

Documents required

For obtaining license for Commercial Testing Laboratory, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Procedure for obtaining license

Procedure for obtaining license for Commercial Testing Laboratory. Download the pdf file for more detail and prepare the documents accordingly.

Application Form & Fee

List of Forms & Fee for obtaining the said license is provided below. Download the pdf file and prepare the Form accordingly and submit the required fee.

Form-36

Download the below pdf file

For Cosmetics

Form-Cos-22

For Medical Devices

Form-MD-39

Schedule L 1

Submit your application (Online and / or hard copy) to State Drugs Controller / Licensing Authority of your area after completing all the required documents.

Note: Requirements of some of documents and procedure for submission of application may vary from State to State


Requirement and condition of license

Conditions of licenses is to be maintained after obtaining the required license for Commercial Testing Laboratory. Download the pdf file for ready reference.

License retention fee

Procedure for submission of license retention fee. Download the pdf file for more detail and prepare the documents accordingly.


List of approved MDTLs

List of approved Testing laboratories for Medical Devices, click below links:

List of 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

State wise list of approved testing laboratories

List of approved Commercial Testing laboratories for drugs, click below link

List of BA-BE Study centre & Bio Analytical Laboratory

DCGI dt 02-08-2021 – Updated list of BA-BE Study centre & Bio Analytical Laboratory under New CT RULE 2019

DCGI-dt-02-08-2021-Updated-list-of-BA-BE-Study-centre-Bio-Analytical-Laboratory-under-New-CT-RULE-2019


Also read about Govt Testing Laboratories, click here


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Food testing laboratories

State wise list of food Analyst – Food testing Laboratories, click below link

State-wise-List-of-Food-Analyst-Food-testing-laboratory


Ayurvedic, Siddha & Unani testing laboratories

List of Ayurvedic, Siddha & Unani testing laboratories, click below links:

List-of-Approved-Testing-Laboratories-for-Ayurvedic-Siddha-and-Unani-Medicines-59

List-of-Assisted-State-Government-Drug-Testing-Laboratories-for-Unani-Medicine-27

List-of-Ayurvedic-Medicine-Testing-Laboratories-and-Government-Ayurvedic-Siddha-and-Unani-Pharmacies


Notifications:

For notifications of Testing Laboratories, click below link:

Notifications – Testing Laboratories


Laboratory Safety Manual

Laboratory Safety Manual – Revised July 2016, click below link

Laboratory-Safety-Manual-Revised-July-2016


List of Laboratory instruments


Download the whole list of laboratory instruments, click below link:

List-of-Laboratory-Instruments


Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana

Commercial Testing Laboratories

Govt Laboratories

List of Laboratory instruments

NABL

Latest Notifications: Testing Laboratories

NABL 164 released : Guidelines for Inter-laboratory comparison

NABL releases NABL 136: specific criteria for X-Ray equipment

NABL: List of NABL Accredited Testing Laboratories

NABL 126: Specific criteria for calibration of Medical Devices

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