for Medical devices

1.Exemption of requirements specified under section 64(1) of the NMRA Act for limited time period.

It is hereby noticed that, after reassessing the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to exempt the requirements specified under section 64 (1) of the NMRA Act for a limited time period when accepting of renewal applications. Therefore, if the expiry of existing registration certificate or expiry of extended registration certificate falls between 2nd September 2021 to 30th May 2022, Section 64 (1) of the NMRA Act No.05 of 2015 will not be considered when submitting the dossiers/documents for renewal of registration.

2.Accepting of Re-Registration Application

It is hereby informed that NMRA will accept re-registration application manually for routine process which is not covered by above (1). (This is not applicable for applications (dossiers) which have been submitted through eNMRA. These application can be submitted with the evidence)

Note : A copy of extended registration certificate and import license should be enclosed with each application (Dossier).A declaration shall be submitted by the applicant if previous registration was not extended.

‍

(Date:18 October 2021)