Introduction: Central Drugs Standard Control Organization For Medical Devices
Have you ever wondered about the consequences if the medical devices operating in the country started giving wrong results? How chaotic can this be for the people and the country? For instance, a patient with Covid, who could have been saved if diagnosed earlier, became a victim of the bitter truth of life, Death. And, why? Only because the medical device used to run his/her test was faulty. Seems pretty unfair, right! Fortunately, such situations don’t reflect the reality of the present and the credit for that goes to India’s national regulatory authority - CDSCO. Also referred to by people as the Central Drugs Standard Control Organization, CDSCO, comes under the Directorate General of Health Services, Ministry of Health and Family Welfare. As per the Drugs and Cosmetic Act of 1940, CDSCO acts as the central drugs authority and oversees the import, manufacturing, trading, and distribution of drugs, including medical devices in the country. Additionally to this, its responsibility includes regulating & approving new drugs and their clinical trials for quality checks to ensure the safety of public health as a priority remains at the top. This article will introduce you to the importance of CDSCO online registration for Indian Medical Device Companies and the procedure to obtain it as well.
Table of Contents
- Introduction: Central Drugs Standard Control Organization For Medical Devices
- Purposes For CDSCO Online Registration
- Compliances Required for CDSCO Online Registration
- Types of Applicants Eligible for CDSCO Online Registration
- Documents Required for Online CDSCO Registration
- Process to Obtain CDSCO Online Registration
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CDSCO Online Registration
Any mistake on the part of Indian medical companies, including pharmaceuticals while dealing in drugs can create a catastrophic situation for the country, which can become too complicated for the government to handle and not to forget the unimaginable consequences full of destruction. And this is why the CDSCO stands as such of high significance today. Being the country’s national regulatory authority, the Central Government has bestowed CDSCO with the responsibility to make regulations and norms for drugs and cosmetics with the motive to ensure the safety, basic rights, and welfare of the patients. Alongside this, the Central Drugs Standard Control Organisation (CDSCO) also keeps a check on the qualitative and efficiency-related aspects of products manufactured, imported, or distributed by the Indian Medical Device Companies in the country.
CDSCO also provides State Drug Control Organizations with guidance and expertise from time to time and maintains coordination with them in periodic activities. Today, CDSCO online registration is mandatory for every entity that manufactures, imports or exports drugs and cosmetics and does drugs-related R&D (Research and Development) operations. Besides this, the organizations that import drugs for the purpose to conduct BA (Bioavailability) & BE (Bioequivalence) studies in drugs for export are also bound to obtain it.
Now that we have been seeing the term ‘medical devices’ again and again, it’s important to understand what actually defines it.
As of the current definition under the regulatory frameworks, medical devices are the devices that come into use during medical operations. For example, medical apparatus, instruments, appliances, etc. These medical devices can come into use individually or in combination for purposes, such as analysis, prevention, observation, mitigation, or treatment of diseases related to human beings or animals. And, all the Indian Medical Device companies dealing in such products are required to obtain CDSCO registration, and violation of this on their part can lead them to legal troubles.
Purposes For CDSCO Online Registration
But not anyone can apply for the CDSCO online registration as the CDSCO has laid down a list of purposes only for which an organization can obtain it. To check them, go through the below-mentioned list:-
- Registration of Cosmetic Products
- Drugs Manufacturing or Importing
- No Objection Certificate (NOC) for the export of drugs
- Test License to import medical devices to test, evaluate, or conduct clinical trials
- Registration under Ethics Committee
- Formulation Research and Development Organization
- Registration of Blood Bank
- Registration of Blood Products
- Dual Use No Objection Certificate (Trader)
- BA (Bioavailability)/BE (Bioequivalence) Approved Sites
- Sponsors (BA/BE and CT)
Compliances Required for CDSCO Online Registration
- ISO 13485 (India’s Medical Devices Quality Management System Certificate).
- Full Quality Assurance Certificate /CE (European Conformity) Product Quality Assurance/ CE Type Examination Certificate
- CE (European Conformity) Design Certificate
- Declaration of Conformity
- An undertaking that all the information provided by you is authentic and stands true as per your knowledge
- Certificate of Free Sale (Also referred to as “Certificate to Foreign Governments or “Certificate for Export”)
- The Plant Master File
- The Drugs Master File
Types of Applicants Eligible for CDSCO Online Registration
Below, we have mentioned the types of applicants eligible for CDSCO online registration under the act:-
- Indian Agents
- Foreign Enterprises holding Indian Subsidiary
Documents Required for Online CDSCO Registration
The followings are the documents Indian medical device companies must gather to apply for online CDSCO registration
- Identification proof of the applicant
- Address proof of the applicant
- An undertaking granted by a government authority.
- For BA/BE approved sites registration, a copy of BA or BE Site Registration as approved by CDSCO is also required.
- For purposes including, import or manufacture of drugs/blood product registration/test license registration, documents associated with Manufacturing or Wholesale licenses are also necessary.
Process to Obtain CDSCO Online Registration
Below, we have mentioned the step-by-step process to get CDSCO Online Registration. Make sure you follow every step carefully:-
- Visit the CDSCO Online Registration Portal and then go to the Login/Sign Up Page.
- After that, visit the Registration Purpose page and then click Submit.
- In the Application form, fill in all the asked details, such as applicant type, username, name, contact number, and email address. After that, attach the identification proof and the undertaking issued to you by the government authority.
- Fill in the business details in the ‘Registered Indian Address Form,’ such as the organization’s name, type, CIN (Corporate Identification Number), and address details. After that, attach the document related to the corporate address proof.
- After that, you will receive a confirmation link on the registered email address for verification purposes.
- Once the verification is done, the application for CDSCO online registration will be forwarded to the CDSCO officials.
- If the CDSCO officials find everything satisfactory, you will receive approval on the registered email address.
Note: In case the online CDSCO registration application gets rejected, you will receive a rejection mail on the same email address.
Let us conclude this article with the hope that you have found it informational and useful. With this, we have given our best to explain to you the significant roles CDSCO online registration plays and the process through which the Indian medical device companies can apply for it. If you’re among the entities who seek to get online CDSCO registration but getting hesitant due to the requirement of compliance, then, without any hesitation, get in contact with the experts of Corpseed ITES, who are well-known throughout the country for their business, technical and legal consultancy services.
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This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.
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