The registration process for medical device wholesalers, traders, and retailers is essential to ensure the traceability and regulatory compliance of medical devices sold in the market. Previously, grocery stores, shopping centers, and similar establishments could sell certain medical devices with minimal regulation. However, the need for stringent regulations has become apparent to safeguard public health and ensure the quality and safety of medical devices. As a result, businesses that sell medical items, including reading glasses, adult diapers, gloves, orthopedic assistive devices (wheelchairs, walkers), face masks, prophylactics, condoms, and oxygen concentrators, are now required to be registered traders.
In response to the need for enhanced regulation, the Ministry of Health and Family Welfare introduced the Medical Devices (5th Amendment) Rules, 2022, which amend the Medical Devices Rules, 2017. These amendments are made under the authority of Section 12(1) and Section 33(1) of the Drugs and Cosmetics Act, 1940. The amendments were published on September 20, 2022, and include the following key provisions:
1. Rule 87A: This rule mandates the registration of businesses involved in selling, stocking, exhibiting, or distributing medical devices, including in vitro diagnostic medical devices.
2. State Licensing Authority: Appointed Licensing Authorities are responsible for registration in specified areas.
3. Registration Certificate Requirement: All persons or institutions intending to sell, offer for sale, exhibit, stock, or distribute medical devices must obtain a Registration Certificate.
To obtain the Registration Certificate (Form MD-42), applicants must follow these steps:
1. Submission of Form MD-41: The applicant must fill out Form MD-41 and submit it to the State Licensing Authority.
2. Online Registration:
- Access the CDSCO MD-online portal.
- Register using personal information and confirm via OTP.
-Create a password and log in using the generated ID and password.
3. Form Completion:
-Fill out the application form, indicating the relevant project unit.
- Verify the certificate being applied for and the government agency to which the application is submitted.
4. Fee Payment: Pay the required fees online.
5. Application Scrutiny: The concerned department will scrutinize the application. If deficiencies are found, they will raise questions. If the application is in order, it will proceed to further audit and inspection according to the Medical Device Rules, 2017.
The following documents are necessary for the registration process:
1. Firm Constitution Documents:
ID Proof of Proprietor/Partnership Deed/CIN Document & Self Declaration of the Proprietor.
2. Details of Proprietor/Partner/Director/Trustee:
Bio data and photos in .jpg format.
3. ID Proof of Proprietor/Partner/Director/Trustee:
Aadhar/Passport/Driving License/Election ID/PAN Card.
4. Rent/Lease Agreement:
Preferably 5 Years. If own place - Sale Deed/Land Registration Agreement.
5. Premises Ownership Documents:
Property Tax Receipt / ID proof of Owner of the Building (Aadhar/Passport/Driving License/Election ID/PAN Card/Property Tax/Registration of Firms).
6. NOC:
Provisional Certificate of Clinical Establishment Act / Trade Licence / GST Registration Certificate.
7. Electricity Bill of the Premises:
A1 Commercial Service.
8. Plan Layout:
Certified by the Registered Engineer.
9. Cold Storage Proof:
AC & Refrigerator Invoice / Working Condition Certificate.
10. Appointment Letter of the Competent Person.
11. Acceptance Letter of the Competent Person.
12. Experience Certificate of the Competent Person:
Medical Devices.
13. Self-Declaration of the Competent Person.
Once the application and documents are submitted, the State Licensing Authority will review them. If the application complies with the requirements and rules of the Medical Devices Regulations, the authority will grant the Registration Certificate in Form MD-42. If the application is found non-compliant, the authority will reject it within ten days, and the applicant can appeal within forty-five days of refusal.
1. Display: The Registration Certificate must be prominently displayed in the public area of the business premises.
2. Storage Conditions: Maintain required temperature and lighting conditions for medical device storage.
3. Purchase Source: Medical devices must be purchased from registered manufacturers or licensed entities.
4. Record Keeping: Maintain separate records of purchases and sales, including details of manufacturers/importers, batch numbers, and expiry dates.
5. Inspection: Records must be available for inspection by the Medical Device Officer and preserved for at least two years from the date of entry.
6. Self-Certification: Ensure compliance with Good Distribution Practice (GDP) requirements.
The MD-42 certificate is valid indefinitely, but the retention fee must be paid every five years. Failure to pay the retention fee on time will result in a 2% late fee. If the fee is not paid within six months, the license will be revoked.
Before canceling a registration, the certificate holder is given a chance to explain. If the registration certificate is canceled, the holder can appeal within forty-five days. The state government must decide on the appeal within sixty days.
An applicant can appeal against the rejection of an application or the cancellation of a registration certificate within forty-five days. The state government will review and decide on the appeal within sixty days.
Registering as a medical device wholesaler, trader, or retailer ensures compliance with regulatory standards and enhances the traceability of medical devices. For assistance with the CDSCO Form MD-42 registration, it is advisable to consult experienced legal advisers, such as those at ValuExpert, who offer free initial consultations to guide you through the process.