CDSCO (MD) Registration in India

CDSCO or The Central Drugs Standard Control Organisation is a National Regulatory Authority under the Directorate General of Health Services. CDSCO is a Government of India undertaken by the Ministry of Health and Family Welfare. The organization regulates the country's New Drugs and Clinical Trials. The organization is governed under the following:

• Drugs & Cosmetics Rules of 1945
• Drugs & Cosmetics Act of 1940

The Central Drugs Standard Control Organisation defines the standards for Drugs, such as controlling the quality of imported drugs and cosmetics. The CDSCO coordinates activities with the State Drug Control Organisation (SDCO). It also offers expert advice on the enforcement of the Drugs & Cosmetics Act regulations.

Any organization that engages in any of the following activities needs to obtain CDSCO Registration through its online registration portal:

• Manufactures Drugs & Cosmetics
• Imports-Exports drugs & cosmetics
• Conduct Research & Development activities regarding Drugs & Cosmetics
• Imports Drugs & Cosmetics for examination
• Conducts BA (Bioavailability) studies on Drugs and Cosmetics for export
• Conducts BE (Bioequivalence) studies on Drugs and Cosmetics for export

 

Why must we obtain CDSCO Registration for Medical Devices?

You can obtain the CDSCO Registration for various purposes. We have enlisted the eligible purposes for CDSCO registration under the portal of CDSCO in the following steps:

• Blood Product Registration
• Trader's Dual Use No-Objection Certification
• Registration for Blood Bank
• Import or Manufacture of Drugs/Cosmetics
• Registration of Ethics Committee
• Registration for Cosmetics
• Bioavailability Approved Sites
• Bioequivalence Approved Sites
• Formulation of Research and Development Organisation
• Test License
• BA/BE Sponsors and CT Sponsors
• Zone-specific Export No Objection Certificate

 

Eligibility Criteria for CDSCO Registration of Medical Devices

The following entities can apply for the online CDSCO medical device registration process in India:

• Indian Agents
• Corporate Bodies
• Import Firms
• Foreign Enterprises operating through their Indian Subsidiaries

The applicant, as a manufacturing unit, cannot register directly on the CDSCO portal. Therefore, the parent corporate body must create login credentials for the manufacturing team. Through these credentials, the MU can log in on the CDSCO portal.

 

Products/Devices under CDSCO Registration

The CDSCO department caters to multiple divisions of Drugs and Cosmetics in India. Let us discuss them one by one.

Cosmetics

The Drugs & Cosmetics Act defines the Cosmetic as an item that is deliberately pat, sprayed, or used or applied to the human body parts or whole for any of the following purposes:

• Decorating
• Cleaning
• Glowing
• Changing the appearance

A Cosmetic product also includes items intended for use as a component of another cosmetic production. Under the Cosmetic Act, the State Licensing Authority controls cosmetics manufacturing under a system of examination. The concerned State Governments assign this Authority. However, the import of cosmetics from Foreign Lands is governed under a registration system by a Central Government appointed Authority.

Bioavailability and Bioequivalence

Bioavailability is the amount of drug that reaches the intrinsic circulation. Such chemicals can have an active effect on the human body, whereas two drugs are said to be bioequivalent if they function similarly in all intent by providing equivalent proportions.

New Drugs

The CDSCO considers it vital for the new drug products to illustrate their safety & efficacy for use by humans before it is green-flagged for manufacturing or import in the country. The Drugs & Cosmetics Rules defines the New Drugs as a chemical comprising of any of the following which has not been used in India to a remarkable extent:

• Bulk Drug substance
• Phytopharmaceutical Drug

Medical Devices

The Drugs & Cosmetics Act regulates the notified medical devices in India made thereunder in 1945. These notified medical devices include the following:

• Substances used for Artificial Insemination recognition
• Incision Dressing stapes
• Sutures
• Bandages
• Ligatures
• Blood
• Component collection bag w/w/o anticoagulant

The CDSCO-approved medical devices can also contain substances comprising the following:

• Prophylactic Techniques
• Intrauterine Devices
• Antiseptic
• Insect Killer

Biological Products and Vaccinations

Biological products are medical extracts biologically available from various natural sources on earth. These products are aimed at treating diseases & other syndromes. Biological products can also be used to prevent or diagnose/prognose diseases.

You can use any of the following as a Biological Product for the treatment of medical conditions:

• Human Organs
• Human Cells
• Human Tissues, primarily for transplantation
• Gene & Cellular Therapies
• Blood Donor test
• Allergic extracts from plants used for treatment & diagnosis

 

Documents required for CDSCO Registration of Medical Devices

The applicant must submit the following documents along with the CDSCO registration application for medical devices to further their candidature to the Authority for the requisite license:

• Proof of Identification of the CDSCO applicant
• Proof of Residence of the CDSCO applicant
• Copy of BE or BA. Site Registrations that the CDSCO has issued
• Undertakings allotted by the appropriate Authority
• Wholesale/Manufacturing License if the devices have been manufactured or imported within the country

 

Procedure for CDSCO Registration of Medical Devices

Nowadays, the applicant can file the CDSCO Registration for medical devices online. It is a complete digital procedure. Here, we have defined the procedure for CDSCO Registration for medical devices in the following enumerations:

• The applicant must begin by visiting the online CDSCO web portal SUGAM.
• Apply for registration. Go to the Registration Purpose page, fill in the basic details, and click the submit button.
• The Application Registration page will open up.
• Then, fill in the required information as provided in the e-form, which includes the following:
  • Type of Applicant entity
  • Name of the Applicant company
  • Registered User Name of the applicant post login
  • Chosen Password
  • Contact Number
  • Email ID

The applicant must also fill out the e-Address Form containing the following details:

• • Organization Name
  • Organization Type
  • Company Identification Number
  • Contact Number
  • Address Proof of Corporate Facility
• Upon submitting the application form, the Authority will send you a confirmation link to your registered email Id for verification.
• Click on the link you received in your mail to activate your account on the CDSCO official portal.
• After activating the account, you can send the CDSCO Registration application to the Authority for the required approval.
• If the Authority approves your application for CDSCO Registration, it will send an approval email to your email ID. If the CDSCO rejects your application, the Authority will send the rejection email to your ID.
• Upon receiving the approval mail, your CDSCO Registration procedure will be completed.

 

Our Assistance in getting the CDSCO Registration for Medical Devices

A Cosmetic license for medical devices is an old authorization, but not many can provide it to you. That's not the case with us. At Registrationwala, we perceive your need to register medical devices with an analytical eye. We provide the following services with respect to Medical Device registration:

• Drafting your cover letter
• Ensuring the correct documentation at hand
• Submitting your application
• Conducting a thorough follow-up
• Dealing with any discrepancies 

Registrationwala assists in every matter of CDSCO Medical Device registration. And another reason to choose us is the low professional CDSCO Medical Device registration fees. Our CDSCO license consultants charge nominally but deliver exponentially.

So why wait? Contact our CDSCO registration consultants at site:www.registrationwala.com and start getting licenses for Medical Devices today.