CDSCO Registration Certificate

CDSCO Overview

CDSCO stands for Central Drugs Standard Control Organisation (which comes under the Ministry of Health and Family Welfare), headquartered in Delhi and has 6 zonal offices in India namely at Mumbai, Kolkata, Chennai, Ghaziabad, Hyderabad and Ahmedabad and various other sub-zonal offices. It is the national regulatory body for products like cosmetics, drugs, medical devices, etc.

Different divisions of the CDSCO are as below

• Medical device division (Drugs)

• Drugs

• Cosmetics

• Clinical Trial on medical devices division

• Vaccines

• BA/BE

CDSCO Certificate Eligibility

Eligibility for a CDSCO Certificate requires meeting regulatory guidelines.

All manufacturers, either of Indian or foreign origin, can apply for the CDSCO license. In the case of a foreign manufacturer, the license will be granted to the manufacturer, and the Indian counterpart of the manufacturer will act as its authorized Indian Representative. The Indian representative of the manufacturer must have a valid state drugs license under Form 20-B/21-B or Form 42 (applied under Form 41) as per the latest guidelines released by CDSCO.

CDSCO Device Classification

Medical devices are categorized into four classes by the Medical Device Rules 2017

• Class A ( least risk )

• Class B ( Moderate risk )

• Class C ( Moderate to high risk )

• Class D ( High risk )

CDSCO Registration can be obtained through online portal registration

• Class A ( non sterile and non measuring ) products come under registration scheme.

• Class A ( Sterile or measuring ) products require license.

This brings us to the conclusion that products which are under Class A ( sterile or measuring ), Class B, Class C and Class D require a license from CDSCO.

Required Documents for CDSCO LICENSE

CDSCO registration for Class A products ( non-sterile and non-measuring )

• Drugs license of importer (Required only for foreign manufacturer)

• Free sales certificate (Required only for foreign manufacturer)

• ISO certificate (Required only for foreign manufacturer)

• List of products to be registered

• Basic details about the product (example: storage temperature, shelf life, model number, etc.)

Class A ( sterile or measuring ), Class B, Class C and Class D

• Plant Master File (PMF)

• Device Master File (DMF)

• Manufacturing process flowchart

• Labels and user manual

• Design verification and validation

• Stability validation data

• Challan of the government fee paid

Class A Product Registration Process

Process for CDSCO registration for Class A products ( non-sterile and non-measuring )

• Generation of login Credentials

• Registration of Indian / foreign manufacturer

• Registration of importer ( in case of import only )

• Addition of product details

• Submission of details to CDSCO

• Grant of registration

TIMELINECDSCO registration process will take 1 day after the documents are submitted to us.

Process For CDSCO License

• Identifying the class of the medical device

• Making groups as per the guidelines mentioned as per CDSCO guidelines

• Creation of login credentials for the manufacturer

• Collection of documents from the overseas manufacturer

• Collection of documents from Indian importer

• Checking and vetting of documents as per the rules

• Payment of government fees

• Submission of Application online

• Clearing of queries ( if any )

• Audit of the firm

• Clearing of queries ( if any ) after the audit

• Grant of license

• Generation of CDSCO certificate

TIMELINEApprox 6-8 weeks after submission of application.

VALIDITYIt is granted for 5 years initially and renewed thereafter by paying the government fees.

• In case of CDSCO import license, AUDIT OF THE FOREIGN MANUFACTURER IS NOT CONDUCTED, and rest of the procedure remains the same.

• License number mentioned on the CDSCO registration certificate has to be mentioned on the products / packaging.

• Test license is also required in case of Indian manufacturers.

Specialized LicensesIf you are applying for a license for a new drug, biological product, or innovative medical device, additional approvals such as clinical trials or safety testing may be required.

For further assistance or to ensure proper filing, you can consult a regulatory consultant experienced in CDSCO processes.

CDSCO License Consulting Services

As CDSCO registration certifications, our job is to ensure that the tiring procedures listed above become a cakewalk for you. Right from the beginning, i.e., from the stage of collection of documents from foreign manufacturers or preparation of documents for Indian manufacturers, conducting thorough compliance checks, coordinating submissions, addressing department queries, and following up with the department for the grant of a license, everything is under our scope of work.

We are one of the most experienced CDSCO certifications in the field of medical products,we provide apex quality of services possible to all our national and international clients.