Are you indulge in the services of cosmetics, pharmaceuticals, and medical devices then let me inform you that the CDSCO Registration is necessary for your organization. Without CDSCO approval you cannot enroll in this kind of business to regulate your products in India or another country. So, before applying for the CDSCO Certificate let just go deep in understanding the necessary terms that you have to understand before applying online for a CDSCO license.
Apply For CDSCO Registration In India
What is The Full Form Of CDSCO?
The full form of CDSCO is the Central Drugs Standard and Control Organization.CDSCO is a National Regulatory Authority (NRA) that work for the cosmetics, pharmaceuticals and medical devices. It is one of the powerful organization in India for the CDSCO registration. The NRA is operate under the directorate General Of Health Services, MInistry Of Family Welfare, And the Government Of India.
For the safety and security of the product, the Government of India has announced its plan to bring all the medical devices, including implants, cosmetics, and contraceptives under the review of CDSCO. The CDSCO organization is responsible to approved the product quality and provide the license for the multiple specialized categories of critical drugs. The products that need CDSCO registration in India are as follows blood, blood products, I.V. Fluids, Vaccine, injections, Medical devices, Sera, & more.
What Is CDSCO Registration?
CDSCO registration is a approval from the side of the Central Drugs Standard and Control Organization. The CDSCO license is issued by the organization after the assurance of quality and efficiency of products of medical devices, pharmaceuticals, and cosmetics.
The approval of CDSCO shows that the product is not harmful to use & devoid of harmful elements. The certificate ensure that it is safe for the public and no harm to animals during production.
The registration of CDSCO is necessary to have for the better regulatory of medical device in India.
What Is The Purpose Of CDSCO License?
There are multiple purpose of CDSCO registration that you have to understand. The different purpose of the CDSCO certificate are as follows:-
- Test License
- Import or Manufacture Of Drugs
- Cosmetics Registration
- Export NOC (Zone)
- Blood Bank Registration
- Blood Product Registration
- Test License
- Ethics Committee Registration
- Formulation R & D Organization
- BA/BE Approved Sites
- Sponsors (BA/BE/CT)
Who Can Apply For CDSCO Registration In India?
If you are from the mentioned category then you can apply online for the CDSCO Registration In India:-
- Indian Agents
- Importers and Manufacturers
- Foreign Enterprise Holding Indian Subsidiary
- Dealer of Medical Devices
Notice – A manufacturer cannot apply directly on the website or portal. A corporate has to create a login credential through which manufacturer registration can login into it for the application.
What Are The Different Division Of CDSCO?
The CDSCO is divided into different section. The different section of the Central Drugs Standard and Control Organization are:-
- Cosmetics – Under the drugs and Cosmetics Act, Cosmetics means the product that are directly used on the human body or any part for cleaning, glowing, and changing the appearance. These items are such as gel, spray, or any other. Any item that is used as a component of cosmetics.
- DCC-DTAB – These are the authorities that give suggestions on the matter that is raised out of the administration of the Act & Rules. It must be done by the changing in the pertinent particular of Drugs & Cosmetics Act & Rules. DCC-DTAB is the authority that organizes the meeting of the effective checking of rules. It also arranges the meetings to organize meetings effectively.
- BA/BE – BA and Bioavailability assure the amount of the drugs that are effective to use for a particular body in any item. BE stands for Bioequivalence When the two drugs are used in an equivalent proportion are said to be a BE Drugs.
- Import and Registration Of Drugs – Under Chapter III of the Act and Part IV of the Rules import of drugs in India is governed. In this, the registration and the medical device import license of the drugs are processed according to the drugs and cosmetics rules.
- New Drugs – The testing and the safety of new drugs are essential before they are consumed by humans or the manufacturing and importing of the product for a particular pharmaceutical product. The uses and consumption of new drugs are defined under the Rule 122-E of the Drugs & Cosmetics Rules.
- Medical Device And Diagnostics – In India, all kinds of drugs are not allowed to be consumed for medical devices. Currently, for medical devices, you can only use selected drugs under the Act & Rules of Drugs & Cosmetics made thereunder in 1945.
- Biological – Some of the biological products are medical products. Some of the biological products available in the market are from natural resources.
- Vaccines – Gene and cellular therapies, blood donor tests, humans/organs/cell/tissue used fro transplantation, Allergic extract from plants that is used for diagnosis and treatment.
Necessary Documents For CDSCO Registration In India
If you are willing to apply for the CDSCO registration in India then you have to submit the following documents. Without these documents you are not allowed to apply for the CDSCO License:-
- Form MD – 1
- Identity Proof Of The Applicant
- Address Proof Of The Applicant
- Covering Letter
- Description of the Product
- Test Protocol
- Quality Certificates
- Instructions For Use
- Undertaking From The Government Authority
- Fee Challan
- Legal Form
- PMS Surveillance
How To Apply For CDSCO Registration Online?
The Registration of CDSCO Application is complete online process. To apply for CDSCO certificate follow the step by step guidance and apply CDSCO License In India:-
- Visit The CDSCO Registration portal.
- Click on the registration
- Go to the registration purpose page and click to submit
- When you open the registration page, fill in the necessary information Applicant Type, Name, User Name, Password, Mobile Number, Email ID.
- Fill out the Indian Addressed Form Registered Organization Name and Type, CIN, Contact Number, and Address, and Upload the Corporate Address Proof.
- When you submit the form later you will receive a confirmation mail on registered mail.
- Go to that mail and confirm the account to activate your CDSCO portal.
- Once the email is confirmed the application will sent to the concerned authority of the CDSCO for approval and review.
- Once your application for CDSCO is approved you will receive a mail on your registered mail. If due to any circumstances your application got rejected you will receive the mail of rejection.
- Once you receive the approval mail your CDSCO registration is completed.
How Does MDR Help You In CDSCO Registration?
Medical Device Registration Consultant will help you to make this CDSCO registration process simple and easy for you. They will assist you and fill in the registration form on your behalf. Our experts will assist you and update you about the status of your medical device registration.
Frequently Asked Questions
What is CDSCO?
CDSCO is an organization that is accountable for CDSCO registration in India of medical devices and drugs regulatory in India.
Who Approved Medical Devices in India?
The medical device in India is approved by the Drug Controller General of India or DCGI.