The Indian medical device industry is currently experiencing a significant transformation with the Ministry of Health and Family Welfare (MoHFW) introducing amendments to the Medical Device Rule 2017 to strengthen the medical devices ecosystem further.
A notification was issued on 30th Sep 22 by the Ministry of Health & Family Welfare introducing the concept of “Registration Certificate” in Form MD-42 as an alternative to the wholesale license in Form 20B & 21B to sell, distribute, or offer medical devices for sale in India. This is indeed a welcome move on two main accounts:
- Allows importers/distributors an easier & faster process for getting necessary approvals to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical devices.
- Wholesale License holders for medical device currently need to comply with drug specific storage requirements whereas this draft notification stresses on complying to requirements as applicable to the medical device being stored.
This blog will provide an overview of the new regulations and the process for obtaining a registration certificate for the sale of medical devices in India.
Key Point of Medical Devices (Fifth Amendment) Rules, 2022
The new amendment to the Medical Device Rule 2017, mandates persons or businesses to obtain a registration certificate for sale to sell, distribute, or offer medical devices for sale in India. The new rules in Medical Device Rule 2022 have been inserted after Rule 87 and are as follows:
“Rule 87(A). Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.” —
Under this sub rule, the State Licensing Authority shall appoint licensing authorities to issue registration certificates. The applicant submits the application in Form MD-41 along with various documents and fees, including a self-certification of compliance with Good Distribution Compliance and proof of identification, ownership, or occupancy, technical staff qualifications, and an undertaking to comply with storage requirements. The State Licensing Authority will grant the registration certificate in Form MD-42 if all requirements are met.
“Rule 87(B). Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.” —
Rule 87(B) outlines the conditions that must be met by the holder of a registration certificate which include prominently displaying the registration certificate, providing adequate storage space and proper storage conditions, maintaining the required temperature and lighting, purchasing medical devices only from licensed manufacturers or entities, and maintaining detailed records of purchases and sales. These records must be open to inspection by a medical device officer, who may also take samples for testing. All registers and records must be preserved for a minimum of two years, and an inspection book must be maintained in Form MD-43 for the Medical Devices Officer to record their observations and findings.
“Rule 87(C). Validity of registration certificate.” —
According to Sub rule 87(C), a registration certificate issued in Form MD-42 will remain valid permanently if the registration certificate retention fee is paid before completion of five years from the date of its issue.
“Rule 87(D). Suspension and cancellation of Registration Certificate.” —
As per the sub rule 87(D), if the holder of a registration certificate violates any provisions of the Act or rules, the State Licensing Authority can suspend or cancel the certificate by issuing a written order after giving the holder an opportunity to explain why such action should not be taken.
Steps to Obtain a Registration Certificate:
Step 1: Apply on Form 41 for the grant of a registration certificate to the State Licensing Authority (SLA).
Step 2: Upload the prescribed fees challan as per the second schedule of Medical Device Rules 2017 and amendments thereof.
Step 3: The State Licensing Authority will review the application and, if found satisfactory, will grant the registration certificate in Form 42.If rejected, the applicant may file an appeal with the state government within 45 days of rejection.
Step 4: Maintain an inspection book in Form MD-43 for the medical officer to record their observations and findings.
About Regulatory Solutions India
Regulatory Solutions India (RSI) is a company that has been paving the way in regulatory consulting since its inception in 2011. RSI has successfully registered over 400 products in India, including medical devices, IVDs, and cosmetics across 25+ categories, such as stents, catheters, intraocular lenses, orthopedic implants, ablation devices, surgical dressings, hypodermic syringes and needles, and many more. With satisfied clients from 15+ countries, RSI offers a unique combination of technical, strategic, and project management support, all backed by their extensive industry experience.
At Regulatory Solutions India, we understand that the process of registering products can be daunting, which is why we offer comprehensive support throughout the entire lifecycle. We assist companies in preparing their applications and navigating the complexities of the central licensing authority in India, CDSCO. We work tirelessly to ensure that our clients’ products obtain successful registrations, making it possible to market their products in India. Let Regulatory Solutions India guide you through the regulatory process and help you unlock the potential of the Indian market.
FAQ's
1. Do I need a warehouse/distributor license to sell medical supplies in India?
Yes, After the implementation of medical device rule 2022, any person or individual who wishes to sell, stock, exhibit, offer for sale, or distribute a medical device, including an in-vitro diagnostic medical device, will require a registration certificate in Form 42 (i.e. wholesale/distributor license) from the respective state licensing authority.
2. What is form 41?
The application form to be filled out by the applicant and submitted to the State Licensing Authority (SLA) for the grant of a registration certificate to sell, stock, exhibit, or offer for sale or distribution.
3. What is form 42?
After the successful submission of the application in Form 41, the SLA will review your application and, if found satisfactory, will issue a registration certificate in Form 42.
4. What is form 43?
Form 43 is an inspection book that must be maintained by the applicant for the medical device officer to record their observations and findings.
