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Overview of the new amendments to the Medical Device Rule 2017
The Indian medical device industry is undergoing a major transformation with the introduction of new amendments to the Medical Device Rule 2017 by the Ministry of Health and Family Welfare (MoHFW). These changes aim to strengthen the medical devices ecosystem in India. One of the most significant changes is the introduction of a “Registration Certificate for sale of medical devices” in Form MD-42, which acts as an alternative to the wholesale license in Form 20B & 21B for the sale, distribution, or offer of medical devices in the country.
Advantages of the introduction of the Registration Certificate
This move has two main advantages. Firstly, it allows importers and distributors an easier and faster process for necessary approvals to sell, stock, exhibit, or distribute medical devices, including in vitro diagnostic medical devices. Secondly, the draft notification stresses on the compliance of requirements applicable to the medical device being stored, unlike the current drug-specific storage requirements that wholesale license holders must adhere to.
Key Points 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 to sell, distribute, or offer medical devices for sale in India. The new rules in Medical Device Rule 2022 are inserted after Rule 87 and consist of four sub-rules:
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 must submit 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. These 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 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 the 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 for sale of medical device :
Step 1: Apply on Form 41 for the grant of a registration certificate to the State Licensing Authority (SLA) Step 2: Submit the fee prescribed by the state licensing authority Step 3: Review and grant of registration certificate in Form 42
About Regulatory Solutions India
Regulatory Solutions India (RSI) is a company that has been leading 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, the process of registering products is made easy and comprehensive through the entire lifecycle. The company assists companies in preparing their applications and navigating the complexities of the central licensing authority in India, CDSCO. The team works tirelessly to ensure that clients’ products obtain successful registrations, making it possible to market their products in India. Regulatory Solutions India offers guidance through the regulatory process and helps clients unlock the potential of the Indian market.
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