Last Updated on January 6, 2024 by The Health Master
As part of bringing the medical devices sector under a larger regulatory framework, the Union ministry of health and family welfare (MoHFW) is taking steps to mandate registration certificates for sales of medical devices both from the country and overseas.
The registration certificate to sell, stock, exhibit, offer for sale or distribute a medical device, including in-vitro diagnostic medical devices, will be made mandatory through an amendment to the Medical Devices Rules, 2017 (MDR).
Objections and suggestions on the draft should be submitted within a period of 45 days from the date of publication of the draft notification, following which the government will issue the final notification.
The Ministry has issued a draft notification with an amendment to the MDR, inserting a set of rules which stipulate a registration certificate for the stocking and sales of medical devices, the conditions the sellers have to follow as per the new rules, the validity of the certificate, and the suspension or cancellation clauses for the registration certificate.
So far, under the Rule 87 of the MDR, the provisions for the sale of medical devices stipulate that “Subject to the provisions of the rules, Part VI relating to the sale of drugs other than Homoeopathy medicines of the Drugs and Cosmetics Rules, 1945, shall be applicable mutatis mutandis in respect of sale of medical devices.”
The amendment in the Rule 87 has been proposed to insert a Rule 87(A) for registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.
The State Licensing Authority (SLA) shall appoint licensing authorities for the purpose of issuing the registration certificate, and any person who intends to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device shall make an application in Form MD-41, which has also been introduced in the draft rules, to the SLA for grant of the certificate.
The application shall be made along with a fees prescribed in second schedule of the rules, self certificate of compliance with respect to good distribution compliance, details of the applicant or firm including its constitution, along with identity proof, documentary evidence in respect of ownership or occupancy on rental of the premises and details of competent technical staff under whose direction and supervision the sales activity of medical device shall be undertaken and such staff shall possess the educational qualification including a degree of a recognised university or a registered pharmacist or one who has passed intermediate examination or its equivalent examination from a recognised board with the one-year experience in dealing with sale of medical devices.
A brief description of the other activities carried out by the applicant, such as storage of drugs, medical items, and others in the said premises, should also be attached with the application. It shall also be accompanied with an undertaking that the storage requirement to sell, stock, exhibit, offer for sale or distribute a medical device will be complied with.
The SLA shall grant a registration certificate in Form MD-42 if the documents are satisfactory or else reject the application for reasons to be recorded in writing, within ten days from the date of application.
If the application is rejected, the seller can file an appeal before the state government within 45 days from the date of receipt of rejection, and this appeal may be disposed within a period of 60 days from the date of its receipt.
Under 87(B), the Ministry says that the registration certificate shall be displayed at a prominent place in the premises visible to the public, the certificate holder shall provide adequate space, proper storage condition for storage, and required temperature and lighting as per the requirements of such medical devices shall be maintained.
The medical devices shall be purchased only from an importer or licensed manufacturer or registered or licensed entity under the rules.
Separate records, in form or invoice or register or electronic details including software of purchases and sales of medical devices showing the names and quantities of such medical devices, names and addresses of the manufacturers and importers, batch number or lot number, expiry date shall be maintained.
It shall be open for inspection by the medical device officer appointed, who can also take samples for testing.
All registers and records shall be preserved for a period of not less than two years from the lat entry. An inspection book in Form MD-43should be maintained by the certificate holder for the medical devices officer to record observations and defects notices.
The registration certificate on Form MD-42 shall remain valid in perpetuity, under Rule 87(C), subject to payment of a retention fee before the completion of five years from the date of issuance. Rule 87(D) has also been inserted regarding the suspension and cancellation of the registration certificate.
The amendment also inserts a provision for registration certificate under the Rule 34, in sub-rule (1) regarding the application for grant of import licence.
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