Introduction: Medical Wholesales/Traders and Retailers

Grocery stores, shopping centers, etc., had the opportunity in the past to use a straightforward registration method for recalls and traceability by regulators and manufacturers. Looking at the necessity of registering Medical Devices Traders and Resellers, Shopping Malls, etc., to increase the scope of regulating Devices Industries. Now that they are registered traders, businesses can sell medical items, including minor packages like reading glasses, adult diapers, gloves, orthopedic assistive devices (wheelchairs, walkers), face masks or prophylactics, condoms, oxygen concentrators, etc.

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New Regulation from the Department of Health and Family Welfare

Looking into the need, the Ministry of Health and Family Welfare runs (Department of Health and Family Welfare) government has made the Medical Devices (5th Amendment) Rules, 2022 to the Medical Devices Rules, 2017 as per the requirement of Section 12 (1) and Section 33 (1) of the Drugs and Cosmetics Act, 1940.

From the recent amendment made on September 20, 2022, the following changes have been made to the rules of the Medical Device 2017, these are:

• The words “Wholesale License for Sale or Distribution” and “Registration Certificate in form MD-42.” 
• In rule 87(1) following sub-rule is added

Rule 87A For Registration certificate to sell, stock, exhibit, or offer for sale or distribute a medical device, including in Vitro diagnostic medical device- 

1. The State Licensing Authority appointed Licensing Authorities for Registration for such for certain specified areas.
2. Persons or Institutions who intend to sell, offer for sale or exhibit, stock, or distribute Medical Devices, In vitro diagnostic devices shall have to grant a Registration Certificate.
3. For Registration, the applicant has to fill the form MD-41 to Concerned the State Licensing Authority for the Sell, Stock, distribution, exhibit, or offer for sale.

Process of Registration

The process for submitting a Form MD-41 registration application is as follows:

• Through the CDSCO MD-online portal, the applicant must access the CDSCO’s online application submission facility.
• Using your personal information, register on the website.
• Through the confirmation of the OTP, a password is generated. The portal stores the Email Id and Password.
• Visit the portal’s home page and log in using your generated ID and password.
• Fill out the application and indicate the Project unit it falls under.
• Verify the certificate you’re applying for, the project’s unit, and the government agency to which the application is being sent.
• When the payment page loads, pay the necessary fees.
• The concerned department will scrutinize the application, and a question will be raised if any deficiencies are found. If the application is in order, it will move forward for further audit and inspection by the concerned department by the Medical Device Rules, 2017.
• If the applicant is found noncompliant, this will be communicated to him, and the resulting audit report and NC closure will be uploaded.
• The process will move forward if the audit report is deemed satisfactory.
•  If the inspection report conforms to the standards, the application for the license award will be submitted.
• A license must be given while noting the required CDSCO conditions.

Documents Required

• The applicant’s self-certification of compliance that such goods fully comply with the Contract’s Good Distribution Compliance (GDP) requirements, which is the minimum standard that a distributor must meet to make sure that the quality of medicines is as required and that the right product is delivered to the right addressee within the required time frame.
• Applicants’ Details, such as Aahar card and PAN card
• Details of the constitution of the firm (MoA &AoA);
• Documentary evidence of the Premises (Ownership Letter, Rent agreement, etc.)
• Details of Technical staff under whose supervision the sales activities of medical devices  shall be done, the qualifications and experience required by the technical staff shall be as follow:

1. UG/PG degree holder from a recognized University/Institution in the relevant field; or,
2. A registered Pharmacist, or,
3. Intermediate or equivalent qualification with a minimum of one year of experience in selling medical devices.

• Details of other activities such as medical equipment storage, drugs, stationeries, food products, etc., including any other action the applicant is carrying out on the premises.
• An undertaking by the applicant for the sale, exhibit, or offer for the sale of the medical device.

Fee Required

• A registration cost of Rs. 3000/- and an additional Rs. 3000/- must be paid for the retention fee for the registration certificate for the sale of medical devices.

Grant of Application

• The State Licensing Authority shall have the power to grant a Registration Certificate. The authorities shall scrutinize the application and other attached documents, and after satisfied that the applicant has complied with the requirements and rules of Medical Devices, shall grant the certificate in Form MD-42, 
• Suppose the applicant has not followed the Registration process and rules mentioned in the Medical device regulations, mentioning the same. In that case, the Licensing authority should reject the application within ten days from the date of filing of the application.
• On the rejection of the application, the applicant can prefer an appeal before the State Government within forty-five days from the date of refusal.
• The state government shall, within sixty days, hear the applicant and decide whether the appeal shall be granted.

Condition of Registration Certificate

• The grant of Registration under Rule 87A of the Medical Devices Rules, 2017 shall be displayed at a prominent place in the Public.
• The applicant must provide details of Space and Storage Conditions for the Medical Devices Storage.
• The Registration holder shall maintain the required temperature and proper lighting per the required conditions.
• The medical devices shall be purchased from the registered Manufacturer or licensed entity.
• Separate records, in the form of register or electronic details, including software of Purchases, Medical devices including name and quantities of medical devices. Name and address of the Manufacturers or Importers, batch number/lot number, and expiry details shall be maintained.
• The records shall be inspected by the Medical Device Officer appointed under sub-rule 2 of rule 18, who may enquire about the purchase and sale of medical devices and can inspect the same.
• The records and registration details shall be preserved for at least two years from the date of entry.
• The Registration holder shall maintain an inspection register in form MD–43 to enable the Medical Device Officer to inspect and notice the defects.

Validity of Registration Certificate

• The MD-42 certificate that the Authority issues will be valid indefinitely, but the retention fee will need to be paid after the allotted period has passed until five years have passed since the certificate was issued. Additionally, the State Licensing Authority should not, however, cancel the certificate.
• If the registration certificate does not pay the retention amount before the deadline, a late fee of 2% of the retention amount will be assessed until the payment is made; however, if the needed amount is not paid within six months, the license will be revoked.

Cancellation of Registration Certificate 

Suppose the certificate holder violates the terms of the medical certificate regulations or state licensing authority. In that case, they must provide the certificate holder a chance to explain why their license should not be suspended before ordering the suspension and providing written justification.

Appeal

• Within 45 days of the cancellation of Registration, the certificate holder must file an appeal with the state government.
• The state authority will consult with the registration holder before confirming, rejecting, or changing the cancellation order.