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SKV Solutions Pvt Ltd

CDSCO MDR APPROVAL

CDSCO:

 The Central Drugs Standards Control Organization, which is part of the Ministry of Health and Family Welfare, regulates all medical goods and imports of cosmetics in India. Under CDSCO, the Drugs Controller General of India is responsible for issuing a license for Allopathic Drugs, Veterinary medicines, medical devices, Homeopathy, cosmetics, etc. The primary goals of CDSCO are to protect and promote public health. The Drugs & Cosmetics Act 1940 and rules 1945 have given various responsibilities to central and state regulators for regulating drugs & cosmetics.

DIVISIONS OF CDSCO

The Central Drug Standards Control Organization has the following divisions

  1. New Drugs
  2. Import and Registration
  3. Biologics
  4. Bioavailability/Bioequivalence
  5. Medical Device & Diagnostics
  6. Cosmetics
  7. Clinical Trials
  8. DCC-DTAB

WHO CAN APPLY

All manufacturers, either of Indian or foreign origin can apply for the CDSCO licence.In case of foreign manufacturer license will be granted to the manufacturer and the Indian counterpart of the manufacturer will act as it’s 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.

Classification of Device as per Application

All types of medical devices are divided into 4 classes by the Medical Device Rules 2017, in 4 main categories, namely

1. Class A ( least risk )
2. Class B ( Moderate risk )
3. Class C ( Moderate to high risk )
4. Class D ( High risk )

Class A products are further divided into 2 categories to ascertain if CDSCO license or CDSCO registration is applicable on the product:

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

VITAL DOCUMENTS REQUIRED FOR

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

1. Drugs license of importer ( Required only for foreign manufacturer )
2. Free sales certificate ( Required only for foreign manufacturer )
3. ISO certificate ( Required only for foreign manufacturer )
4. List of products to be registered.
5. Basic details about the product ( example: storage temperature, shelf life, model number, etc.) , etc.

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

1. Plant Master File ( PMF )
2. Device Master File ( DMF )
3. Manufacturing process flowchart.
4. Labels and user manual.
5. Design verification and validation.
6. Stability validation data.
7. Challan of the government fee paid, etc.

PROCESS OF ONLINE REGISTRATION FOR CLASS A Products (NON Sterile & NON Measuring)

  • Generation of login Credentials.
  • Registration of Indian / foreign manufacturer
  • Registration of importer ( in case of import only )
  • Addition off product details
  • Submission of details to CDSCO
  • Grant of registration.

Timeline : CDSCO registration process will take 1 day after the documents are submitted to us.

Validity : Validity of CDSCO online registration is perpetual i.e. no end date and requires no renewal.

Note : After the registration is completed, a unique file number is generated, which has to be mentioned on the product / packaging, in case of registration there is no certificate

PROCESS FOR CDSCO LICENCE

  • 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.

Timeline : Approx 6-8 weeks after submission of application.

Validity : It is granted for 5 years initially and has to be renewed after that by paying the government fees.

Note: 1.) In case of CDSCO import license, AUDIT OF THE FOREIGN MANUFACTURER IS NOT CONDUCTED, and rest of the procedure remains the same.
2.) License number mentioned on the CDSCO registration certificate has to be mentioned on the products / packaging.
3.) Test license is also required in case of Indian manufacturers.