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CDSCO - Medical Device Wholesale License

Overview of Medical Device Wholesale License

Every country in the globe has a competent government agency under the Ministry of Health that is responsible for managing all issues pertaining to medicines and medical devices. In India, the CDSCO is in charge of overseeing the registration and sale of recognized medical devices. The CDSCO has authority over the registration and sale of classified medical equipment in India. The Directorate General of Health Services, an organization within the Indian Ministry of Health and Family Welfare, is in charge of managing and monitoring CDSCO. 

To get a CDSCO Wholesale License, one must provide a current, duly notarized copy of Form 20B & 21B as per the Drugs and Cosmetics Rules, which permit the sale or distribution of drugs. If the CDSCO Whole License has to be renewed, the manufacturer (or the subsidiary office/representative of the parent business or its agent) receives Forms 21C from the State Licensing Authority of India.

Understanding CDSCO

The Central Drugs Standard Control Organization, or CDSCO, is in charge of managing the medical device industry in India. The Rules of 1945 and the Drugs and Cosmetics Act, of 1940 control it. Indian medications are registered using the CDSCO process. The Central Drugs Standard Control Organization is India's governing body for pharmaceuticals and medical equipment.

Foreign producers may appoint Indian Authorized Agents (IAA). It is a licensing body that authorizes the import of new chemical substances, or medicines, into India. Every country has its own separate government, which is a branch of the Ministry of Health. It administers every aspect of medical equipment and pharmaceuticals.

The Drugs & Cosmetics Act states that CDSCO is in charge of approving medications, carrying out clinical trials, developing drug standards, keeping an eye on the quality of medications that are imported into the country, and coordinating the work of State Drug Control Organizations by providing expert advice in an effort to guarantee uniformity as per the Drugs and Cosmetics Act.

What is the importance of a Medical Device Wholesale License?

Businesses that distribute, trade, or wholesale medical equipment are required by law to get a Medical Device Wholesale License (Form 41). Medical Device Wholesale License in Form 41 is issued by the Central Drugs Standard Control Organization (CDSCO), which is controlled by the Indian Ministry of Health and Family Welfare. This license ensures that medical devices are produced, stored, and distributed in a way that is high-quality, safe, and efficient.

Classification of Medical Devices in CDSCO

Medical devices are categorized into four groups by the Central Drugs Standard Control Organization (CDSCO) in India according to the degree of danger they pose to users and patients. The device's intended use and the possible harm it may cause in the event of a malfunction are the basis for the categorization system. 

Medical device classification according to Indian CDSCO: 

Class A: Low-risk medical devices with little to no chance of harming users or patients, such as bandages, stethoscopes, and other standard medical equipment. 

Class B: Low-to-moderate-risk medical equipment, such as syringes, blood pressure monitors, and needles, that might injure users or patients if they break down but don't pose a life-threatening risk.

Class C: Medical devices with a moderate to high risk of malfunctioning that might seriously hurt or injure patients, such as orthopedic implants, artificial heart valves, and catheters. 

Class D: High-risk medical devices that are vital to a patient's health and survival and have the potential to be fatal or seriously harmful if they malfunction, such as ventilators, pacemakers, and heart-lung machines.

What are the requirements for Medical Device Wholesale License Registration?

The requirements for getting a Medical Device Whole License are mentioned below:

  • The Medical Devices Rules, 2017's Rule 87A requires that the registration certificate shall be prominently displayed to the public.
  • Details on the space and storage conditions for the storage of medical devices must be provided by the applicant.
  • The registration holder is responsible for maintaining the appropriate lighting and temperature under the specified circumstances.
  • The medical equipment must be obtained from a licensed organization or registered manufacturer.
  • Records, such as registers or electronic data, containing software related to purchases and medical equipment, together with the names and quantities of such products shall be maintained. It is also required to preserve the batch/lot number, expiration information, and the name and address of the manufacturers or importers.
  • The Medical Device Officer designated under sub-rule 2 of rule 18 is entitled to review the records and may inquire about the sale and purchase of medical devices.
  • The records and registration information must be kept in a file for a minimum of two years from the date of such entry.
  • To allow the Medical Device Officer to check and identify any flaws, the registration holder must keep an inspection register in form MD 43.

Advantages of getting a Medical Device Wholesale License

The following are the advantages of getting a Medical Device Wholesale License in India:

Quality Assurance

The license guarantees that IVDs and medical equipment are disseminated and preserved in the best possible ways to maintain their effectiveness.

Legal Compliance

Failure to get a medical device wholesale license may result in legal issues and penalties. Compliance with Indian laws is guaranteed by a current medical device wholesale license.

Building Trust

Having a medical device wholesale license makes your company more credible in the healthcare industry and helps to build trust with patients and other stakeholders.

Market Access

Suppliers must hold the required licenses in order to do business with many hospitals, clinics, and healthcare organizations. This allows licensed enterprises to reach a larger market.

Who can obtain a Medical Device Wholesale License?

The following is a list of businesses or individuals who can register for the medical device wholesale license:

  • Indian importers
  • Agents
  • Corporations
  • Foreign Companies having Indian Subsidiaries

What are the documents required to obtain a Medical Device Wholesale License?

The documents required for a medical device wholesale license are as follows:

  • A cover letter describing the objectives of the application.
  • A complete Application for a medical device wholesale license in Form 19.
  • Challan of fees paid for getting permission for a distribution license.
  • Declaration format in the approved manner as advised by the appropriate authorities.
  • The property's perimeter and total area or floor arrangement.
  • Proof that the applicant is the rightful owner of the property.
  • Documents that specify the kind of company the applicant has created, such as an AOA or MOA and a certificate of incorporation.
  • Affidavits confirming the applicant has not committed any offense listed under the Drug and Cosmetic Act, 1940. Verify that the authorized individual has signed the affidavit.

A letter of appointment designating the applicant as a full-time, registered pharmacist

Process of obtaining a Medical Device Wholesale License

The process listed below is necessary to get a medical device wholesale license. You can apply online for a CDSCO wholesale license. The steps to register on the CDSCO site are as follows:

Step 1: Visit the CDSCO Website

Go to the registration page for CDSCO. On the top of the portal, select the "Login/Sign up" button.

Step 2: Start the Registration Process

After that, select "Sign up Here" to begin the registration process. You will be directed to the "Registration Purpose Page". To submit, click the button at the end.

Step 3: Fill the Application form

Select the page for applicant registration. Fill out the application details form. It includes information such as the password and applicant type. Now, you will be requires to upload the ID proof and submit the undertaking. 

Step 4: Fill the Address Form and Submit the Application

Next, complete the form for the Registered Indian address. This includes details like the Organization Type, Contact Number, and Name of the Organization.

Upload the Corporate Address proof at last. Once you have filled all the details, simply click on Submit?.

Step 5: Activation of CDSCO Account

An email with a confirmation link will be sent to the email address you registered with upon submission. In order to Activate your CDSCO account, click the email link

Step 6: Grant of Medical Device Wholesale License Registration

The application will be forwarded to the relevant Authority (CDSCO Officials). If the application is approved, an email requesting approval will be sent to the relevant email address. Your registration for a CDSCO Wholesale license is complete once you get an email confirmation approval.

Why Choose PSR Compliance for Medical Device Wholesale License Registration?

A medical device wholesale is not merely a legal requirement, but this license is a symbol of a company's dedication to patient safety and quality. This license is proof of a company's commitment to following rules and regulations and helping the Indian healthcare industry flourish. PSR Compliance helps distributors and wholesalers of medical devices obtain a medical device wholesale license quickly and easily. With years of experience in the same domain, we are committed to offering the best services all over India. Not only this, we provide end-to-end support with real-time updates to our clients. Connect with us for more details. 

Frequently Asked Questions

Q1. Which license is required to sell medical devices in India?

In India, a wholesale drug license form 20/21B or a registration certificate form 41/42 is required in order to sell any kind of medical device.

Q2. What is the concept of voluntary registration in CDSCO?

Voluntary registration is for all Class C and Class D items that have not been informed in accordance with the CDSCO notice. The registration process is conducted online, and voluntary registration is free of charge with no CDSCO fees.

Q3. Who is authorized to approve medical devices in India?

Medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), a division of the Ministry of Health and Family Welfare.

Q4. What is an MD 42 license?

The State Licensing Authority issues the MD 42 Legal Medical Device Registration Certificate to retailers, wholesalers, or distributors so they can sell, stock, display, offer for sale, or distribute medical devices, including In-Vitro diagnostic devices.

Q5. What is the validity of a Medical Device Wholesale License?

The medical device wholesale license is valid for an infinite period, but there is a condition that the license fee has to be paid after five years of issue.