The Ministry of Health and Family Welfare or MoHFW notified G.S.R. 777 (E) on 14th October 2022, Notifying about the Medical Devices (Sixth Amendment) Rules, 2022. A draft for the same was issued in notification no. G.S.R. 710(E) on 20th September 2022, which this notification has further finalised as “Medical Devices (Sixth Amendment) Rules, 2022”. The Amendment informs about the provisions related to the Registration of Class A (Non-Sterile and Non-Measuring) Medical Devices under the Medical Device Rules 2017.
Overview of the Medical Device Rules, 2017
The Central Drug Standard Control Organization (CDSCO) is the highest regulatory authority in India. It is responsible for checking medical device standards and regulating them from time to time. It is accountable for granting licenses for manufacturing and importing medical devices in India. Medical device rules, 2017 have been introduced by CDSCO to regulate the regulations related to the manufacture and Import of Medical devices in India. The Medical Device Rules 2017 classifies Medical Devices into four types based on their risk classification, which is listed as follows-
- Medical Devices with Low Risk- Class A
- Medical Devices with Low- Medium Risk- Class B
- Medical Devices with Medium-High Risk- Class C
- Medical Devices with High Risk- Class D
CDSCO is also responsible for performing various functions to ensure that customers use good quality and certified medical devices. The tasks of CDSCO are as follows-
- Medical device imports
- Medical device manufacturing
- Medical Device Clinical Investigation
- Approval of Investigational Medical Devices
- Performing clinical tests on Medical devices
- Coordination with State Licensing Authority (S.L.A.)
Regulations of the Sixth Amendment
The Medical Devices (Sixth Amendment) Rules, 2022, has been notified by the Ministry of Health and Family Welfare, in a notification vide GSR 777 (E) dated 14th October 2022. The notification made a few rules to amend the Medical Device Rules 2017, under which a new chapter III B has been included after rule 19 F. The Amendment also regulates provisions related to the Registration of Class A (Non- Sterile and Non-Measuring) Medical Devices. Seven Rules (19 G-19 M) have been inserted in the new amendment chapter.
According to Rule 19-G, Chapter III B would apply to all non-sterile and non-measuring medical devices classified as Class A Medical devices under Schedule I of the Medical Device Rules, 2017. The registration process for these devices shall be done through an Identified Online Portal made for this purpose.
Documents required by Manufacturers of Class A (Non-Sterile and Non-Measuring) Medical Devices
According to Rule 19H of the Medical Devices (Sixth Amendment) Rules, 2022, the manufacturer of Class A non-sterile and non-measuring medical devices must submit the required information for medical device registration through an online portal.
The documents which are required to be submitted by the manufacturer are-
- Name and Address of manufacturing site
- Medical device details such as-
- Generic Name
- Dimension (If applicable)
- Model no. (If any)
- Brand Name ( If the device is registered under Trade Marks Act, 1999)
- Material of Construction
- Intended use
- Shelf life ( If applicable)
- The manufacturer must submit an undertaking stating that the proposed medical device is a Class A medical device (non-sterile and non-measuring) under Medical Device Rules 2017, Schedule I.
- The manufacturer must submit a self-certification stating that the product conforms to the essential principle checklist for product safety and performance.
- The manufacturer must submit a self-certification stating that he will comply with the Standards specified in the Medical Device Rules, 2017.
- The manufacturer must submit an undertaking signed by him, mentioning that the information furnished by the applicant is authentic and genuine.
Documents required by Importers of Class A (Non-Sterile and Non-Measuring) Medical Devices
According to Rule 19J of the Medical Devices (Sixth Amendment) Rules, 2022, the Importer of Class A non-sterile and non-measuring medical device must submit the required information for medical device registration through an online portal.
The documents which are required to be submitted by the Importer are-
- Name and Address of Importer and Manufacturing site
- Medical device details such as-
- Generic Name
- Dimension (If applicable)
- Model no. (If any)
- Brand Name ( If the device is registered under Trade Marks Act, 1999)
- Material of Construction
- Intended use
- Shelf life ( If applicable)
- The Importer must submit an undertaking stating that the proposed medical device is a Class A medical device (non-sterile and non-measuring) under Medical Device Rules 2017, Schedule I.
- The Importer must submit a self-certification stating that the product conforms to the essential principle checklist for product safety and performance.
- The Importer must submit a self-certification stating that he will comply with the Standards specified in the Medical Device Rules, 2017.
- The Importer must submit a self-attested copy of the overseas manufacturing site or establishment or plant registration in the country of origin issued by the competent authority or a Free Sale Certificate issued by the National Regulatory Authority.
- The Importer must submit an undertaking signed by him, mentioning that the information furnished by the applicant is authentic and genuine.
The registration number for Class A (Non-Sterile and Non-Measuring) Medical Devices
Rule 19-I and Rule 19-K of Chapter IIIB of the Medical Devices (Sixth Amendment) Rules, 2022, give information about obtaining a registration number for Class A Non-Sterile and Non-Measuring medical devices by Manufacturer and Importer, respectively. The Medical Devices (Sixth Amendment) Rules, 2022 guides that the registration number shall be granted for Class A (Non-Sterile and Non-Measuring) Medical Devices after furnishing the information submitted by the Manufacturers and Importers on the “Online system for Medical Device”, which is established for the same purpose.
Maintenance of records by Manufacturers and Importers
Rule 19-L of the Medical Devices (Sixth Amendment) Rules, 2022, instructs the Manufacturer or Importer that they must maintain all the records of manufacturing or import along with the sales and distribution. The Manufacturers or Importers must produce all the Records, Instructions and Labels for use if the licensing authorities request so. The Licensing Authorities may also verify the records and documents to investigate quality or safety-related issues.
Cancellation or Suspension of registration
Rule 19-M of the Medical Devices (Sixth Amendment) Rules, 2022 provides information on the Cancellation or Suspension of registration of Class A (Non-Sterile and Non-Measuring) Medical Devices. Suppose the registration has been cancelled or suspended. In that case, the State licensing Authority or Central licensing Authority must give the registrant a chance to explain why the registration must not be cancelled or suspended. If the Authorities are not satisfied with the reasons, they must pass an order in writing, mentioning the grounds for cancellation or Suspension of the registration.
If a person is aggrieved by an Order passed by the S.L.A. or C.L.A., they may file an appeal to the State Government or the Central Government within forty-five days of receiving a copy of such order. After giving the aggrieved an opportunity to be heard, the government may confirm, reverse or modify such orders.
Conclusion
The Ministry of Health and Family Welfare or MoHFW[1] has notified Medical Devices (Sixth Amendment) Rules, 2022, in a notification GSR 777 (E) dated 14th October 2022. Before finalising the Amendment, the MoHW released its draft in the notification GSR 710 (E) on 20th September. The Medical Devices (Sixth Amendment) Rules, 2022 provides information on the rules relating to Class A (Non-Sterile and Non-Measuring) Medical Devices. The rules and regulations might get complicated to understand while obtaining the registration. It is always advisable to get assistance from experts and professionals while obtaining a medical device registration certificate.
