The Medical Devices Rules as Medical Devices (Amendment) Rules, 2022 are notified. (New Rules)
The New Rules provision are for all class A medical device manufacturers. Manufacturers must register themselves through an identified online portal established for this. After furnishing the said information on the “Online System for Medical Devices” established for the purpose, a registration number will be generated.
“An undertaking (is needed) from the manufacturer stating that the proposed device is class A medical device (non-sterile and/or non-measuring), according to First Schedule of the said rules,” the notification read.
Importers of Class A medical devices will have to display the generic name, brand name, intended use, material of construction and shelf life of the product. All class A and class B manufacturers are required to transition to the licensing regime by October 1.
The manufacturer to self-certify that the product is conforming to the essential principles’ checklist of safety and performance of such devices.
WHAT IS CLASS A MEDICAL DEVICES?
In India, medical devices have 4 categories – class A being the low-risk medical devices, class B low-moderate risk, class C moderate-high risk and Class D high-risk.
Class A and Class B medical devices, with low-to-moderate risk to the patient or user will have to transition to the licensing regime with Online registration and self-declaration.
RULE FOR IMPORTER OF MEDICAL DEVICE
Importers of medical devices will upload the name and address of the importer and the manufacturing site along with details of medical devices. The Class related declaration will have to be given by the Importer with undertaking that it conforms to essential principles of safety. Importer must provide an undertaking duly signed by them stating that the information furnished by the applicant is true and authentic.
Interestingly, importers will have to approach the overseas manufacturing site or establishment or plant registration in the origin country, issued by a competent authority for this declaration.
MAINTENANCE OF RECORDS
Manufacturers or Importers are required to maintain records of manufacturing, import along with sales and distribution. Licensing authorities have right to call for this information. For non-compliance, State Licensing Authority (SLA) or Central Licensing Authority (CLA) can cancel the registration number or suspend it.
An appeal can be filed against such an order within 45 days with the State Government or the Central Government.
APPLICATION PROCESS FOR CLASS C AND CLASS D
Class C and D manufacturers have stringent procedures to be adhered to get licenses for manufacturing, which are now being extended to low-risk medical devices as well. Class C includes devices like ventilator and joint implants, Class D includes devices with high risk, like pacemakers and heart valves.
According to the Medical Device Rules 2017, to import or manufacture Class C and D medical devices, manufacturer must obtain prior permission in the form of a manufacturing and Import license from CLA under CDSCO.
For License to sell, manufacture of trade applicants have to submit Form MD-7 for Class C and D and Form MD-9 for manufacture, sell, or distribute Class C and D.
The process involves:
- Registering with the Ministry of Health and Family welfare.
- Submitting Form MD-7 along with business details and other documents.
- CDSCO grants license only for Class C and D medical Devices.
- Class A and B medical devices are governed by the SLA.
- Upon completion of verification, the CDSCO grants a manufacturing license or a loan license under Form MD-9 and MD-10, respectively.
- If the license is rejected, the CLA or CDSCO notifies the reason for such rejection to the applicant within 45 days.
This is only for informational purposes. Nothing contained herein is, purports to be, or is intended as legal advice and you should seek legal advice before you act on any information or view expressed herein. Endeavoured to accurately reflect the subject matter of this alert, without any representation or warranty, express or implied, in any manner whatsoever in connection with the contents of this. This isn’t an attempt to solicit business in any manner.
Sources: business-standard.com, mint.com, https://corpbiz.io