1) Overview:
In the past, stores used a basic system to keep track of recalls and traceability for regulators and manufacturers. But things are changing. Now, we’re thinking of expanding this system to include Medical Devices Traders, Resellers, and even the shops we love to visit. This move is strategic, aiming to boost oversight in the Devices Industries.
So, when businesses register, they get the go-ahead to sell a variety of medical stuff—from everyday things like reading glasses, adult diapers, and gloves to more specialized items like wheelchairs and walkers. And it’s not just that; it also covers things like face masks, prophylactics, and oxygen concentrators, making sure we keep a close eye on the medical device market for everyone’s safety.
2) Changes in the Rules:
The Ministry of Health and Family Welfare, specifically the Department of Health and Family Welfare, has introduced a new regulation known as the Medical Devices (5th Amendment) Rules, 2022. This amendment is in alignment with the requirements outlined in Section 12(1) and Section 33(1) of the Drugs and Cosmetics Act, 1940.
As of the latest update on September 20, 2022, several changes have been implemented in the existing Medical Devices Rules of 2017. The key modifications include:
- The removal of terms such as “Wholesale License for Sale or Distribution” and “Registration Certificate in form MD-42.“
- Introduction of a new sub-rule in Rule 87(1), labeled Rule 87A, which pertains to the Registration Certificate for 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 are designated as the Licensing Authorities for Registration in specified areas.
- Individuals or institutions intending to sell, exhibit, stock, or distribute medical devices and in vitro diagnostic devices are required to obtain a Registration Certificate.
- The application process involves submitting Form MD-41 to the relevant State Licensing Authority, specifying the intent to sell, stock, distribute, exhibit, or offer for sale.
This regulation aims to streamline and regulate the sale and distribution of medical devices, ensuring compliance with updated standards and enhancing oversight in the interest of public health.
3) Step by Step Registration Process:
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4) Required Documents:
- Self-certification from the applicant confirming compliance with the Contract’s Good Distribution Compliance (GDP) requirements. This ensures that the distributor meets the minimum standards necessary to guarantee the quality of medicines, ensuring the correct product is delivered to the right recipient within the specified timeframe.
- Applicant’s details, including Aadhar card and PAN card.
- Firm constitution details (Memorandum of Association & Articles of Association).
- Documentary evidence of the premises, including ownership letter or rent agreement.
- Details of technical staff overseeing medical device sales activities, with qualifications and experience as follows:
- Holder of a UG/PG degree from a recognized University/Institution in the relevant field; or,
- Registered Pharmacist; or,
- Intermediate or equivalent qualification with a minimum of one year of experience in selling medical devices.
- Details of other activities on the premises, such as storage of medical equipment, drugs, stationeries, food products, etc., and any other actions undertaken by the applicant.
- An undertaking from the applicant regarding the sale, exhibition, or offer for sale of the medical device.
5) Fee Details:
The registration fee for the sale of medical devices is Rs. 3000/-, and an additional amount of Rs. 3000/- is required for the retention fee associated with the registration certificate.
6) Granting of Application:
- The State Licensing Authority is empowered to issue a Registration Certificate. Upon scrutinizing the application and accompanying documents, if satisfied that the applicant has adhered to the requirements and regulations of Medical Devices, the certificate will be granted in Form MD-42.
- If the applicant fails to follow the registration process and rules outlined in the Medical Device regulations, the Licensing Authority must reject the application within ten days from the submission date.
- Upon rejection of the application, the applicant has the option to appeal before the State Government within forty-five days from the date of refusal.
- The State Government will conduct a hearing with the applicant within sixty days and make a decision on whether to grant the appeal.
7) Conditions of Registration Certificate:
- The granted Registration under Rule 87A of the Medical Devices Rules, 2017 must be visibly displayed in a prominent public location.
- The applicant is required to furnish details regarding the space and storage conditions for the storage of medical devices.
- The Registration holder is obligated to uphold the necessary temperature and adequate lighting in accordance with the specified conditions.
- Medical devices must be procured from registered manufacturers or licensed entities.
- Separate records, in the form of a register or electronic details, including software, detailing purchases of medical devices, must be maintained. This includes information such as the name and quantities of medical devices, the name and address of manufacturers or importers, batch/lot numbers, and expiry details.
- The records are subject to inspection by the Medical Device Officer appointed under sub-rule 2 of rule 18. The officer may inquire about the purchase and sale of medical devices and conduct inspections accordingly.
- All records and registration details must be preserved for a minimum of two years from the date of entry.
- The Registration holder is required to maintain an inspection register in Form MD-43 to facilitate inspections by the Medical Device Officer and to document any observed defects.
8) Validity of Registration Certificate:
- The MD-42 certificate issued by the Authority remains valid indefinitely; however, the retention fee must be paid periodically, and this obligation extends until five years from the date of issuance. It’s important to note that the State Licensing Authority is not authorized to cancel the certificate.
- Failure to pay the retention amount within the specified timeframe will result in a late fee of 2% of the retention amount until the payment is made. If the required amount is not paid within six months, the license will be revoked.
9) Cancellation of Registration Certificate:
In the event of a violation of the medical certificate regulations or state licensing authority terms by the certificate holder, a fair opportunity to present an explanation must be afforded before the suspension is enforced. Written justification for the suspension must also be provided.
- Appeal:
- Following the cancellation of the Registration, the certificate holder has a 45-day window to file an appeal with the state government.
- The state authority will engage in consultation with the registration holder before confirming, rejecting, or modifying the cancellation order.
Conclusion: In conclusion, the introduction of the Medical Devices (5th Amendment) Rules, 2022 by the Department of Health and Family Welfare marks a significant step towards enhancing the regulation of the medical devices industry. This expansion of registration processes to include Medical Devices Traders and Resellers, along with Shopping Malls, reflects a commitment to comprehensive oversight and public safety. The streamlined registration process, outlined through Form MD-41 and the online portal, ensures transparency and efficiency for businesses seeking authorization to sell a wide range of medical devices. The stringent documentation requirements, coupled with a thorough scrutiny and inspection process, contribute to maintaining high standards and compliance with updated regulations.
The issuance of the Registration Certificate in Form MD-42 comes with clear conditions that focus on the proper storage, sourcing, and record-keeping of medical devices. The State Licensing Authorities play a crucial role in granting and monitoring these certificates, promoting adherence to regulations and public health standards.
