Regulation/Guidelines

New Rules added by the CLA on suspension and cancellation of license of imported Medical Devices.

  • 22nd June, 2022
  • The Ministry of Health and Family Welfare (Department of Health and Family Welfare) under the Government of India, on 18th January 2022, G.S.R.78 (E) released an official gazette with a few new rules on the import of medical devices in India, and the final amendment of this rule G.S.R.174 (E) was released on 4th March 2022.
  • In chapter 5th, named -Import of medical device, after the rule no. Forty-three called – Import of medical devices for personal use a new law Forty-three (A ) called – Suspension and cancellation of licence have been added. It states that –
    1. If the manufacturer or importer, or license holder fails to fulfil the conditions of the import license or any requirements or the various acts of the MDR 2017 rules, then the central licencing authority (CLA) has the right to question the manufacturer or importer or license holder but only after giving them the opportunity to submit the cause with proof why an order to suspend and cancel their license should not be passed, the evidence should be in written form. The cancellation or suspension of a licence issued under the rules, either entirely or in respect of any part of a medical device to which it relates, or order the license holder to stop importing, selling, or distributing the said medical device and, directly, collecting the destruction of the medical device along with its stock but in the presence of an inspector or officer appointed by the Central licensing authority (CLA), only if the CLA feels that the license holder has been failed to follow the conditions of MDR 2017,  of the license or any legislations of the Act or the rule formed.
    2. It is also stated that any person affected by this new rule passed by the Central licensing authority (CLA) can file an appeal to the central government against the order of CLA within thirty days of giving the notice. After an inquiry of the matter, the central government can pass an order which they think fits best in the situation after hearing the applicant’s appeal.
  • Now, these rules shall be called the Medical Devices (Third Amendment) Rules, 2022.
  • From 19th January 2022, the copies of the said Official Gazette were made available to the public.
  • It is also brought to notice that these rules will be considered after the forty-five days of passing the notice, which means giving a transition period of forty-five days to the manufacturers, importers, or license holders.
  • All the objections or suggestions given by the public have been kept in mind by the central government while drafting the final rules.
  • The following import license will be covered under this rule:
    • MD Form 15 – covers the License to import medical devices.
    • MD Form 17 – covers the License to import medical devices for clinical investigations, examinations, assessments, demonstrations, or training.
    • MD Form 19 – covers licenses used to import investigational medical devices from the hospital or health institutions.
    • MD Form 21 – covers import permission of a small number of medical devices used personally.
  • The main aim of these amendments is to have stricter rules and laws so that the quality of medical devices in the Indian market can be maintained.

Summary –

  • As per this new rule in MDR 2017, if the CLA founds about the non-compliance with the import rules of MDR 2017 on the import of medical devices, then the license of such importers or manufacturers can be cancelled.
  • Suppose the manufacturer or importer is able to provide a valid and satisfactory reason for non-compliance with rules. In that case, the importers and manufacturers can continue selling or distributing their medical devices.
  • The main aim behind these rules is to have strict regulations to establish the safety and efficacy of medical devices being used by the public.
  • Prior to rule 43 A, there were no such rules on cancellation or suspension of import licenses in MDR 2017, even if some rules were violated by the manufacturer or importer or license holder.