#cdsco online login

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CDSCO Online medical device manufacturing license

In India, the CDSCO (Central Drugs Standard Control Organisation) regulates cosmetic products and the Drugs and Cosmetics Act, 1940 regulates CDSCO Cosmetic Manufacturing License. After 2013, it became mandatory for all the imported cosmetics for sale to get registered with DCGI (Drug Control General of India); before that, there was no such provision. 

Nowadays, customers are curious to know the ingredients in products & make choices which one is good to buy. Therefore, to start a new cosmetic business and conduct manufacturing, selling, and distribution of products, you need to obtain CDSCO Cosmetic Manufacturing License first. Then, registered cosmetics will need to stick a unique label with the Registration Certificate Number on it. 

Step 1: Application for grant of Manufacturing Licence The applicant has to make application online at the CDSCO portal cdscomdonline.gov.in inrequisite form such as MD-3 (or MD-4 for loan license) for license to be issued on form MD-5, or as applicable as per the Medical Device Rules, along with necessary fees challanas given in fee chart under ‘Forms & Fees’. Fee can be paid through Government Treasurychallan, under Head of Account0210- 04-800-02-00 Other receipts Department Name: Drugs Controller, Rajasthan, Jaipur Office Name: Asstt. Drugs Controller, NDNP, Jaipur, Rajasthan Documents to be uploaded along with the application form: 1. Covering Letter 2. Application Form. 3. Receipt of fees challan 4. Constitution of firm including a. Partnership deed / Memorandum & Article of Association b. Declaration of Proprietor/ Partners/ Director(s)/ Managing Director c. List of all the Partners/ Directors with age & complete postal & residential address. 5. Documents of Site ownership / Tenancy agreement 6. Plant Master File (as per appendix I of Part III of fourth schedule) Apart from the mandatory information as per appendix I of Part III of fourth schedule, following documents should also be submitted: a. Declaration of Manufacturing Chemist. b. Declaration of Analytical Chemist. c. Documents of educational qualification, experience and approval certificates of proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters; Id proof. d. Registration from District Industries Centre. e. Consent to establish & consent to operate from Rajasthan State Pollution Control Board. 7. Device Master File for each product (as per appendix II / appendix III of fourth schedule) 8. Performance Evaluation Report (if applicable) 9. Copy of Test License (if applicable). 10. Undertaking that the manufacturing site is in compliance with the provisions of Fifth Schedule. Following additional documents are required if applied for loan license on Form MD-4: 1. Consent letter from principal manufacturing unit in case of loan license. 2. Wholesale licenses of the applicant loan licensee. 3. Valid manufacturing licenses and copies of product permission of the product in question of the principal manufacturer.  

Step 2: Scrutiny of application. In case any shortcoming / discrepancy is noted, query shall be raised. Further action shall be taken upon receipt of reply of query from the applicant. In case the application is found in order, it will be processed for audit of factory premises by a notified body as per Medical Device Rules.  

Step 3: Audit of applicant premises by notified body. The non-compliances, if any, shall be rectified by the applicant. The audit report and the NC closure will be uploaded by the notified body.  

Step 4: Upon receipt of the audit report, it will be examined and if found satisfactory, it will be forwarded for the next step.  

Step 5: Products Scrutiny. The details of the products applied for shall be scrutinized and if they are found to comply with the norms, the application will be considered for grant of license.  

Step 6: Grant of Licence If all the prescribed conditions are complied with, licence is granted 

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CDSCO SUGAM Registration & online Login

SUGAM is a single window interface to access online services offered by CDSCO. This portal allows users to update and upload data on their website related to license of drugs & medical device manufacturing facilities in India. SUGAM portal is a single window interface. To apply for any form user, you need to register on the portal first. The comprehensive database of SUGAM portal includes details of manufacturer, manufacturing site etc. The applications which are submitted on SUGAM online portal are approved/rejected by CDSCO. For the registration process applicants need to submit necessary documents on an online portal. 

SUGAM online portal allows us to avail ourselves of the following services: 

Online submission 

Review 

Grant of license /permission. 

Steps involved in CDSCO SUGAM Registration process: 

Fill in the details given in the registration form and get the login credentials. 

Open the link https://cdscoonline.gov.in/CDSCO/homepage  and sign up. 

After signing up provide the purpose of registration 

Upload necessary documents. 

After online registration, applicants need to submit hard copies to CDSCO for the further verification process. 

Read More - CDSCO SUGAM Portal

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What is CDSCO SUGAM?

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CDSCO Registration For Medical Device

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Purposes For Which CDSCO Registration Can be Obtained

The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority for Indian pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health and Family Welfare in India. It is the responsibility of CDSCO for approving new drugs and conduct of clinical trials in India under the Drugs and Cosmetics Act, 1940 (“Act”) and Drugs and Cosmetics Rules, 1945 (“Rules”). It also lays down standards for drugs and controls the quality of imported drugs and cosmetics in the country for bringing about uniformity in the enforcement of the can grant cdsco registration for different purposes. The different purposes for which an applicant can register under the CDSCO portal are:

Cosmetics Registration

Import or Manufacture of drugs

Export NOC (Zone)

Test License

Ethics Committee Registration

Formulation R&D Organization

Blood Bank Registration

Blood Product Registration

Dual Use NOC (Trader)

BA/BE Approved Sites

Sponsors (BA/BE and CT)

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CDSCO Update on Suspension and Cancellation of License

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CDSCO issued guidelines for medical devices

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CDSCO Registration FAQs 

CDSCO Registration FAQs

Who can register for CDSCO online portal?  

Corporate, Indian Agent, Importer, Foreign Enterprise holding Indian Subsidiary, Cosmetics, Ethics Committee, Formulation R&D Organization, BA/BE Approved Sites, Sponsors(BA/BE & CT)  

How will I login to CDSCO online portal ? 

Frist go to homepage and check on ‘sign in’ under with you will get a link named ‘Sign up Here’ then fill the details and upload the document required with a proper official email id on with all the correspondence activity’s would be done. After your email id gets verified then check further action on register email id. Where you are been required to send the hard copy of document submitted. After which you will get your login credentials on register email id. 

Operon Strategist is  Medical Device Consulting. we can assist the manufacturer in the process of cdsco registration.

I am not able to receive Email or SMS service from CDSCO Portal?   

Check your Junk/Spam folder, so if you receive mail in junk/spam folder then save “ cdscoonline-noida@cdac.in” in your contacts and if not, then please contact to Administrator by “Report a problem” section on home page of CDSCO Portal.  

 If you have selected the option to receive SMS at the time of registration then only you will receive SMS alerts. If done check DND (Do not disturb) settings in your phone. If not, then please contact to Administrator by “Report a problem” section on home page of CDSCO Portal.   Read More - CDSCO Registration FAQs

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Contact details –

Phone  no -  93702 83428Mail id – enquiry@operonstrategist.com