The Ministry of Health & Family Welfare (MoHFW) issued GSR 754 (E) on 30th September 2022, notifying about the Medical Devices (Fifth Amendment) Rules, 2022. A Draft for the same was issued in notification number G.S.R. 104(E) on 9th February 2022, which has further been finalized as “Medical Devices (Fifth Amendment) Rules, 2022”. The Fifth Amendment informs about the provisions related to the sale, exhibit, offer, or stock for sale or distribution of medical devices, including in-Vitro diagnostic medical devices in India.
Overview of Medical Device Rules, 2017
Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority of India. It checks regulations and rules related to Medical Devices, Drugs and I.V.D.s from time to time. It also provides license and registration certificate manufacturing, importing, and conducting clinical investigations and trials. The Medical device rules, 2017 has also classified medical devices based on the risk involved along with every device, which is listed as follows-
- Class A – Medical Devices with Low Risk
- Class B – Medical Devices with Low- Medium Risk
- Class C – Medical Devices with Medium-High Risk
- Class D – Medical Devices with High Risk
Application and Registration certificate of Medical Devices
The Ministry of Health and Family Welfare or (MoHFW) notified the Medical Devices (Fifth Amendment) Rules, 2022, on 30th September 2022 to further amend the Medical Device Rules (MDR), 2017. The Fifth Amendment informed about regulations concerning the registration of medical devices, including in vitro diagnostic medical devices to sale, exhibit, offer or stock for sale or distribution in India. The Amendments have been made in the Medical Devices (Fifth Amendment) Rules, 2022, in which new rules have been Inserted after rule 87, which are as follows-
Rule 87 A – “Registration certificate to sell, stock, exhibit/offer for sale/distribute a medical device including in-vitro diagnostic medical device”
Under this rule, the State Licensing Authority is authorized to appoint licensing authorities to issue medical device registration certificates. A person who intends to sell, stock, offer or exhibit any medical device including in vitro diagnostic medical device, for sale or distribution must apply for the same in Form MD-41 to the State Licensing Authority to obtain the registration certificate for the same.
If the State Licensing Authority is satisfied after verifying the documents and compliances, it will grant the registration certificate in Form MD-42. Suppose State Licensing Authority is not satisfied with the submitted documents. In that case, it may reject the application, along with the reasons for doing so in writing, within ten days of the date of application.
If the application gets rejected, the applicant may also file an appeal before the State Government within 45 days from the date of the rejection. The applicant will then be given a chance to be heard & the case shall be disposed of within sixty days of such appeal.
Documents required along with the Application form
The Medical Devices (Fifth Amendment) Rules, 2022, informs about the registration process of medical devices, including in-vitro medical devices. The new rules have introduced a provision that the following vital documents must accompany the application form MD-41-
- Feed specified in Second Schedule
- Self-certificate of compliance concerning Good Distribution Compliance
- Information related to the firm, such as its constitution, I.D. proof such as Aadhar Card or P.A.N. Card
- Documentary evidence pertaining to ownership or occupancy, or rental of the premises
- Information regarding the competent technical staff, which directs and supervises the sales activity of Medical Devices. The competent technical staff must hold the following qualification and experience-
- A degree from a recognized university or Institution
- They must be a registered pharmacist
- They must have passed the intermediate or equivalent examination from a recognized board with 1 year of experience in dealing with the sale of Medical Devices.
- Short description of other activities carried out by the applicant, such as storage of drugs, food products, medical items, stationery, etc. or any other activity carried out by the applicant on the premises.
- An undertaking that all the storage requirements to sell, stock, exhibit/offer for sale or distribution of a medical device shall be in compliance
Conditions of registration related to Medical Devices
87B. Conditions of Registration Certificate to sell, stock, exhibit/offer for sale/distribute a medical device comprising in-vitro diagnostic medical device
The Medical Devices (Fifth Amendment) Rules, 2022 have laid down certain conditions for obtaining the registration certificate, which is as follows-
- The registration certificate, granted under rule 87A, must be displayed in a prominent space in the workplace, which is easily visible to the public.
- The certificate holder must provide enough space and proper conditions for storing the medical devices.
- The certificate holder must maintain the requisite temperature and lighting according to the requirements of the medical device.
- The medical devices shall be purchased from a licensed manufacturer or importer only.
- Separate records in the form of registers, invoices or electronic details such as software for the sale and purchases of a medical device shall be maintained. The details such as name, quantity, name and address of the manufacturer or importer, batch number or lot number and manufacturer expiry date must also be visible on the device.
- The Medical Device Officer can inspect and enquire about purchases and sales of medical devices, and he can also take samples for tests.
- All the registers and records shall be kept safe for a minimum of two years from the last entry.
- The registration holder must maintain an inspection book in Form MD-43 to allow the Medical Device Officer to note his observations and feedback on the inspection.
Registration Certificate Validity
According to Rule 87 C of the Medical Devices (Fifth Amendment) Rules, 2022, the valid registration certificate issued in Form MD-42 shall be valid for perpetuity, which is subject to payment of the retention fee as mentioned in the second schedule, before five years from the date of issue, unless the certificate is suspended or cancelled by the State Licensing Authority.
If the certificate holder fails to pay the registration fees before the due date, he will be liable to pay late fees at the rate of two per cent of the fees for every month for a total of six months, along with the original fees. In case of non-payment of such fees within the given period, the registration certificate shall be cancelled.
Suspension and Cancellation of Registration certificate
Rule 87D, which has been included in the Medical Devices (Fifth Amendment) Rules, 2022, gives information about the suspension and cancellation of the registration certificate. If the certificate holder contravenes any provisions of the rules, then the State Licensing Authority, after giving the certificate holder a chance to show why the order shall not be made, pass an order in writing by providing reasons for cancellation or suspension of the license.
The registration certificate holder may file an appeal for the same within forty-five days of such order.
Forms Included in the new amendment.
The Medical Devices (Fifth Amendment) Rules, 2022 has also included some forms for the regulations related to the registration of medical devices comprising in-vitro diagnostic medical devices, which are mentioned as follows-
Form MD-41: Application for the grant of Registration Certificate to sell, stock, exhibit/offer for sale/distribute a medical device comprising in-vitro diagnostic medical device
Form MD-42: Registration certificate to sell, stock, exhibit/offer for sale/distribute a medical device, including in-vitro diagnostic medical device.
Form MD-43: Form in which the Inspection Book shall be maintained
The Medical Devices (Fifth Amendment) Rules, 2022, which amend the Medical Devices Rules, 2017, were notified by the Central Government on 30th September 2022, following consultation with the Drugs Technical Advisory Board. According to the rules, any person who does not have a licence but plans to sell medical device exclusively must obtain a registration certificate. The registration process can become complex when it comes to rules and regulations. Therefore, it is always advisable to seek the assistance of experts and professionals to prevent any money, energy, or time losses.
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