Medical Device Wholesalers/Traders and Retailers Registration (CDSCO Form MD-42)

Diagnosing and evaluating patients in this complex healthcare environment requires medical equipment and in-vitro diagnostics (IVDs). The demand for medical devices has increased rapidly due to the changing healthcare sector in India. The Indian government places regulations that organizations need to follow to ensure the safety, accessibility, and quality of medical equipment.

Obtaining a medical device wholesale license Form MD–42 becomes imperative. If you are a wholesaler, retailer, and stockiest of medical equipment, you should receive a registration certification from the state licensing authority on Form MD – 42. The MD 42 Registration Certification is essential from September 30, 2022.

The Central Drug devices and Control Organization or CDSCO monitors Indian medical devices (It is) regulated under the 1940 Drugs and Cosmetic Act and 1945 Rules. Also, the pharmaceuticals from India are registered through the CDSCO process.  The body will permit the importing and manufacturing medical devices, cosmetics, and pharmaceutical products.

New Rules from the Department of Health and Family Welfare

The Ministry of Health and Family Welfare and the Department of Health and Family Welfare have recently introduced a new regulation called Medical Devices (5th Amendment) Rules, 2022. This amendment has Section 12(1) and Section 33(1) of the Drugs and Cosmetics Act passed in 1940.

Some modifications have been made to the initial Medical Devices Rules issued in 2017, which took effect on September 20, 2022. The essential modifications include:

1. The exclusion of phrases such as “Wholesale License for Sale or Distribution” and “Registration Certificate in form MD-42.” “

2. A new sub-rule in Rule 87(1), already known as Rule 87A, deals with the Registration Certificate of the sale, stocking, exhibition, or distribution of medical devices, including in vitro diagnostic medical devices.

The specifics of Rule 87A are as follows:

♦ State Licensing Authorities have been authorized as the Licensing Authorities for Registration in concerned areas.

♦ The distributors planning to sell, display, store, or market medical devices or IVDDs must get a Registration Certificate.

♦ To apply for the Sales Tax License, the applicant has to complete Form MD-41 and submit it to the relevant State Licensing Authority, mentioning his intention to sell, stock, distribute, exhibit, or offer for selling.

This regulation seeks to rationalize and provide the legal framework for the selling and distribution medical devices to meet the new standardization standards and necessary oversight for improving public health.

1. A self-certificate from the applicant confirming compliance with the contract’s Good Distribution Compliance (GDP). It ensures that the distributor complies with the minimum quality standards of medicines and that the right product is delivered to the correct receiver within the stipulated timeframe.

2. Documentary proof of premises, including ownership letter and rent agreement.

3. Applicant information, including Pan Card and Aadhaar Card.

4. Organization constitution details (MOA & AOA)

5. Technical Staff details observing medical device sales activities like qualifications and experience like:

♦ Pharmacist registered

♦ Holder of UG/PG degree from a reputable University in the relevant sector;

♦ Intermediate or similar qualifications with a minimum of 1 year of experience in medical device sales.

6. An undertaking from the applicant sales regarding exhibition and provides medical device sales.

7. Other activities and details on the premises, such as storage of medical devices, food items, drugs, etc., and other actions undertaken by the applicant.

The process of submitting Form MD 42 registration is as follows:

1. Preparation Application

It initiates a comprehensive application with the business organizations that includes details of the business, ownership, structure, personnel, and storage facilities.

2. Documentation

Organizations or individuals must submit address proof, identity, technical information, etc.

3. Premises Condition

The premises where the medical equipment and IVDs are stored and distributed should comply with the regulations set by the CDSCO.

4. Quality Management System 

The applicant needs to set up a Quality management system (QMS) that includes details like managing, distributing, and storing medical equipment. The quality management system ensures compliance with quality standards and regulations instructions.

5. Fees Payment

The applicant must submit 3000/- at the time of submission, valid for years.

6. Onsite Evaluation

After application submission, CDSCO needs to evaluate the premises to check and read compliance with the rules and information given in the application.

♦ The state licensing authority has the power to issue a registration certificate. After scrutinizing the application and other documents, if satisfied that the applicant complies with the requirements of medical devices, then the certification is granted in the form of MD–42.

♦ If applicants can’t process the following rules, the Licensing authority must reject the application within ten days of submission.

​​​​​​​♦ After rejecting the application, they can appeal before the State Government within 45 days.

​​​​​​​♦ The state government will conduct an applicant hearing within 60 days and decide on the grant of the appeal.

​​​​​​​♦ Terms and Conditions of MD 42 Registration Certification

​​​​​​​♦ This registration certificate must be publicly available and placed strategically within the premises.

​​​​​​​♦ There is a requirement that the licensee have enough space and the proper storage conditions for medical devices.

​​​​​​​♦ The licensee shall maintain the temperature and lighting as required by medical devices.

​​​​​​​♦ The licensee shall use the devices he has acquired only from the importer, a licensed manufacturer, or a registered or licensed entity.

​​​​​​​♦ The licensee shall keep records of all sales and purchases of the devices, and all records shall be made accessible to a Medical Device Officer.

​​​​​​​♦ The licensee shall also maintain records of all sales and purchases of the devices. Further, all documents shall be made available to a Medical Device Officer.

​​​​​​​♦ The licensee must retain all the records for at least two years from the last entry.

♦ The authority will issue MD–42 certifications valid indefinitely, but the retention charges should be paid periodically, and obligations remain for five years until the issuance date. Note: The state government is not authorized to cancel the certificate.

​​​​​​​♦ If retention changes are not paid within the deadline, then late fees of 2% of the retention changes until the payment is paid. It will be canceled unless it is paid within six months.

Suppose the certificate holder violates the regulations of a medical certificate or the state licensing authority. In that case, they may allow the certificate holder to show why they should not have their license suspended before suspension occurs. Upon suspension, the certificate holder should be provided written reasons for this action.

Appeal:

♦ If the Registration is canceled, the certificate holder must appeal to the state government within 45 days.

♦ The state authority will discuss the cancellation order with the registration holder before confirming it, rejecting it, or making alterations.

Agile Regulatory plays an important role as an MD 42 medical device wholesale license registration consultant in Noida. We offer a smooth  registration process for obtaining a MD 42 license and ensuring compliance with local and international standards. Our expertise facilitates the efficient registration and licensing of medical devices, helping businesses navigate legal requirements, reduce delays, and boost market entry. By offering tailored advice and support, Agile Regulatory enhances operational efficiency and ensures adherence to regulatory frameworks, crucial for maintaining competitive advantage in the medical device industry.