CDSCO Registration

CDSCO registration as well as CDSCO license is available through following the process of CDSCO online registration through the website.  Team Indiaxis will help to get CDSCO Online Registration/ DGGI License approval according to CDSCO Registration Guidelines. CDSCO is the acronym for Central Drugs Standard Control Organisation (which is part of the Ministry of Health and Family Welfare) It is situated in Delhi and operates six zonal offices throughout India including Mumbai, Kolkata, Chennai, Ghaziabad, Hyderabad, and Ahmedabad as well as other sub-zonal offices. CDSCO is the nation’s regulator for various products such as medical devices, cosmetics, pharmaceuticals, and other medical devices.  Obtain your MOEF Registration License with ease with the help of our expert team at Indiaxis!

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Overviews of CDSCO Online Registration/CDSCO License?

Are you a manufacturers of medical devices and you are looking to sell your products in India?

If yes, so you need to be knowledgeable about the CDSCO regulative procedure associated with obtaining your products approved for use in the Indian market. 

The CDSCO stands for Central Medicines Standard Control Organization (CDSCO) under the Directorate General of Health Services of the Ministry of Health and Family Welfare. Several CDSCO obligations are detailed in the Drugs and Cosmetics Act, varying from authorization of medicines to clinical tests, supplying requirements for medications, and top-quality monitoring of imported medicines.
 
All-in-all CDSCO guarantees coordination of the activities of SDCO (State Drug Control Organisation) while giving professional recommendations and training in harmony in the execution of the Drugs and Cosmetics Act in mind. Not surprising that, it has to ensure smooth coordination with SDCO to take on the operations efficiently.

Major Role of CDSCO Online Registration/CDSCO Certification?

A CDSCO Certification describes an approval granted by the regulatory authority to certain the efficiency and top quality of CDSCO Certification for Drugs, CDSCO Certification for Medical Devices & CDSCO Certification for cosmetics. It stands as a testimony to the dedication to complying with strict policies and adhering to the mentioned criteria for the products.

Under the Drug & Cosmetics Act, the setup of manufacture, sale & circulation of Drugs is a concern of State Authorities while Central Authorities are just responsible for permitting new medicines or medical experiments in the country.

With CDSCO Certificate in hand, you can rest assured that the product you are using has gone through strenuous screening, adhering to standards, and has been extensively examined for its make-up, making procedures, and packaging, leaving no space for concession. In addition, CDSCO is additionally a part of allowing specified categories of medications such as blood and blood items, I. V. Fluids, and injections.

Who can apply for CDSCO Registration/CDSCO License?

Every manufacturer, regardless of Indian or of foreign origin, are able to submit an application for CDSCO license.In cases that a license for a foreign manufacturer is required, the license will be given to the manufacturer, and the Indian representative of the manufacturer acts as its Indian representative. It is essential that the Indian representation of the manufacturer has to have the valid state license for drugs in Form 20-B/21B, as well as Form 42 ( filed in Form 41 ) according to the most recent guidelines issued by CDSCO.

The divisions that make up the CDSCO include:

  • Medical device division ( Drugs )
  • Drugs
  • Cosmetics
  • Clinical Trial on medical devices division
  • Vaccines
  • BA/BE

Classification of Medical Devices as per Regulations

All kinds of medical equipment are classified into 4 categories according to the Medical Device Rules 2017, in four main categories, which are namely

  • Class A ( most risky )
  • Class B ( Moderate risk )
  • Class C ( moderate to High Risk )
  • Class D ( High risk )

Classes A-related products can be further classified into two categories in order to determine whether CDSCO license or CDSCO registration is required for the item:

  • Class A ( non sterile and not measuring ) Products fall under the registration scheme.
  • Classes A ( Sterile or measuring ) products require a license.

This leads up to the conclusion items that fall under the class A ( measuring or sterile ) or Class B, Class C, and Class D need a license with CDSCO.

Vital Documents Required for

A.) CDSCO Registration for products of Class A ( non-sterile and not measuring )

  • License to import drugs ( Not required for any foreign manufacturers )
  • A free sales certification ( Not required for any foreign manufacturers )
  • ISO certification ( Only required for foreign manufacturers )
  • A list of the products that must be registered.
  • The basic information regarding the item ( such as storage temperature and shelf time, model and so on.) , etc.

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

  • Plant Master File ( PMF )
  • Device Master File ( DMF )
  • Process flowchart for manufacturing.
  • User manuals and labels.
  •  Validation and verification of design.
  • Stability validation information.
  • Challan of the fee, etc.

Process for CDSCO Online Registration for Class A products (Non-sterile and Non-measuring)

  • The generation of login credentials.
  • Registration of Indian or foreign manufacturer
  • Registration of the importer ( in the case of import only )
  • Product details added to the product
  • Sending information to CDSCO
  • Registration granted.

Timeline: CDSCO registration is expected to take one day after the documents have been submitted to us.

Validity: Validity of CDSCO on-line registration is permanent i.e. there is no expiration date and no renewal.

Note : When the registration has been completed and a uniquely numbered file is created that must be cited on the packaging of the product or item when registering. there isn’t a certificate

Process of CDSCO License

Identifying the type of medical device.

  • Groups are formed according to the guidelines outlined in CDSCO guidelines.
  • The creation of passwords to log in to the company.
  • Documents collected from the overseas manufacturer.
  • Documents collected by an Indian importer.
  • Vetting and checking documents according to the guidelines.
  • Government fees are paid.
  • Online Submission of Application.
  • Clearing of any questions ( in the event of there are any )
  • Audit of the company.
  • Elimination of questions ( If there are any ) following the audit.
  • License grant
  • Generating of CDSCO certificate.

Timeline : Approximately 6-8 weeks from the date of when you submit your application.

Validity : It’s granted for five years from the beginning and is renewed at the end of each year by paying the fees of the government.

Note: 1.) If you have a CDSCO import license, the AUDIT of the foreign manufacturer is NOT PERFORMED, and the other procedures remain the same.

2.) License number that is mentioned on CDSCO registration certificate should be displayed on the product packaging.

3.) A test license is required for Indian manufacturers.

How Indiaxis help in getting CDSCO Registration / CDSCO License

We are CDSCO Registration consultants, our responsibility is to make sure that the lengthy procedures we’ve outlined above will be effortless for you. From the very beginning i.e. beginning with the collection of documentation from manufacturers from abroad or the preparation of paperwork for an Indian manufacturer, and then following up with the department regarding approval of the license falls within our responsibilities.

We are among the most knowledgeable CDSCO experts on the subject of medical equipment, we provide the best quality services that are available to all of our national and international customers.

FAQ's for CDSCO Registration / CDSCO License

CDSCO certification is a mark of approval from the Central Drugs Standard Control Organisation (CDSCO). CDSCO is a regulatory authority that is part of the Ministry of Health and Family Welfare. 
 
CDSCO certification indicates that a medical device or pharmaceutical meets the required standards. The CDSCO certification process involves a thorough review of the device’s design, manufacturing processes, and performance data. 
 
CDSCO is responsible for the following:
  • Approving drugs
  • Conducting clinical trials
  • Laying down the standards for drugs
  • Controlling the quality of imported drugs in the country
  • Coordinating the activities of State Drug Control Organizations
All manufacturers can apply for CDSCO certification through the CDSCO online registration portal. 
According to the Central Drugs Standard Control Organization (CDSCO), a registration certificate in Form COS-2 is valid indefinitely. However, the registration certificate must be paid a retention fee before the five-year period from the issue date is up. The Central Licensing Authority can also suspend or cancel the registration certificate. 
 
A Form 11 (Test License) is valid for one year unless it’s canceled or suspended. A registration certificate for IVDs is valid for three years.
Eligibility criteria for CDSCO vary depending on the post and other factors:
  • Senior Scientific Officer II: M.Sc in Chemistry, Biochemistry, Pharmaceutical Chemistry, or Sciences
  • Technical Assistant: M.Sc or B.Sc
  • Professional Consultant: M.Pharm in Biotechnology, M.Sc in Biotechnology, Molecular Biology, Genetics, Immunology, Biochemistry, or Microbiology
  • Admn. / Fin.: Retired SO or US-level officers from Central/ State Govt
  • Professional Consultant: 1 to 5 years of experience 
Other eligibility criteria include:
  • Passing matriculation with science or an equivalent examination from a recognized institute or board
  • Knowledge of drugs
  • Sound knowledge of computer operation
  • Experience in testing drugs
The CDSCO is responsible for issuing certifications and ensuring that drugs and medical devices available in the market are safe, effective, and of high quality.
Documents required for CDSCO registration include:
  • Proof of identity
  • Proof of address
  • Copy of BE or BA site registration if approved by CDSCO
  • Undertaking from a government authority
  • Manufacturing license or wholesale licenses if importing or manufacturing drugs, blood products, or registering tests
  • Power of attorney
  • Corporate address proof
  • Manufacturing license or wholesale license details (Form 20B and Form 21B) 
You should keep these documents in PDF format before signing up.
To register with the Central Drugs Standard Control Organization (CDSCO), you can follow these steps:
  1. Register on the CDSCO portal at cdscoonline.gov.in
  2. Choose your registration purpose
  3. Fill in the necessary details
  4. Submit an application form online
  5. Provide ID proof, undertaking, and address proof documents in hard copy
  6. Wait for a confirmation link to be sent to your registered email
  7. Click the confirmation link
  8. The application will be sent to the relevant authority for approval
  9. The CDSCO administrator will either approve or reject the application request
     
CDSCO certification is an approval mark from the regulatory authority that indicates a pharmaceutical or medical device meets the required standards. The CDSCO is under the Directorate General of Health Services, Ministry of Health and Family Welfare. 
To get a CDSCO certificate, you can follow these steps:
  1. Create login credentials for the manufacturer
  2. Collect documents from the overseas manufacturer
  3. Collect documents from Indian importer
  4. Check and vet documents as per the rules
  5. Submit ID proof, undertaking, address proof document in hard copy to CDSCO office
  6. CDSCO will only approve registration after evaluating the submitted documents
CDSCO stands for Central Drugs Standard and Control Organisation. It is India’s National Regulatory Authority (NRA) for cosmetics, pharmaceuticals, and medical devices.