Introduction
This Article deals with Class A Non-Sterile/Measuring Medical Devices which are now exempted from the MD-15 Requirement. The Ministry of Health and Family Welfare has released a new amendment to the Medical Devices Regulations (MDR) 2017. This includes provisions exempting Class A Non-Sterile/Measuring Medical Devices from the approval system, as well as specific Draft Regulations to supplement the Central Government’s proposed Medical Devices Regulations 2017This is a simple registration process and does not need to follow the registration pathway which is followed for other Class A,B,C and D devices.
Class A Medical Devices Registration Requirements
Pathway
19G Application: Applies to all Class A Non-Sterile/Non-Measuring Medical Device classified as Class A Medical Devices according to the first annex. Medical devices referred to in sub-regulation (1) must be registered through the online portal established for this purpose.
19H Uploading: The Class A Non-Sterile/Non-Measuring Medical Device Manufacturers/Importers must upload the information specified in the medical device rules for registration in the “Medical Device Network System” and the Manufacturer/Importer must transmit the information to the network port.
19I Registration Numbers: Registration numbers for Non-Sterile/Non-Measuring Class A Medical Devices are generated upon provision of the information required by regulation 19H in the online Medical Device system established for this purpose.
19J Import of Class A Non-Sterile/Non-Measuring Medical Device: Any person who intends to import Class A Non-Sterile/Non-Measuring Medical Devices must upload the relevant subrule information for the Medical Device in order to register with the online medical device system.
19K Registration Number for Import: Registration numbers for the importation of Class A Non-Sterile/Non-Measuring Medical Devices are generated upon provision of the information required by Regulation 19J in the online medical device system established for this purpose.
19L Maintenance of Records: Manufacturer/importers keep records of manufacturing or importing along with sales or distribution. The manufacturer/importer prepares records, labels and instructions for use as required by the approval authority. Approving authorities may at any time review the records and documents referred to in the sub-regulations and investigate any errors or complaints relating to quality or safety.
19M Cancellation or Suspension of Registration: Rule 19-M of the Medical Device Rules (Sixth Amendment), 2022 provides information regarding the cancellation or suspension of Class A (Non-Sterile/Non-Measuring Medical Device. Suppose the registration has been canceled or suspended, the state registration authority or the central registration authority must give the registrant an opportunity to explain why the registration should not be canceled or suspended. If the authorities are not satisfied with the reasons, they must issue a written order stating the reasons for the cancellation or suspension of the registration.
Documents required for Class A (NS and NM) Medical Devices
- Name and Address of the Manufacturer/Importer
- Class A Non-Sterile/Non-Measuring Medical Device information such as brand name, model number and intended use
- Manufacturer/Importers must self-certify that their products comply with a checklist of ground rules governing the safety and performance of such equipment.
- Manufacturer/importer must self-certify that they comply with the standards laid down in these regulations
- A duly signed statement by the manufacturer/importer that the information provided by the applicant is true and authentic.
Conclusion:
The Ministry of Health and Family Welfare or MoHFW has notified Medical Devices (Sixth Amendment) Rules, 2022, in a notification GSR 777 (E) dated 14th October 2022. It is always advisable to get assistance from experts and professionals while obtaining a Medical Device Registration Certificate. Please Contact Morulaa for more information and register your Medical Device now.
