NMRA has decided to suspend accepting of Waiver of Registration (WOR) applications for KN 95 respirators until the issued once up to 4th December 2020 are reviewed.

1)    NMRA will allow importation of ONLY N95 or KN95respirators (N95 or KN95 mask) to Sri Lanka.      

2)    SurgicalN95 respirators or Medical grade KN95 respirators with exhalation valve is NOT allowed for Importation.

3)   Following documents should be submitted by the applicant / local agent

Request Letter
Business Registration (BR) of the applicant
WOR application (Click here to download)
Test Report including below mentioned test parameters & conclusions (Should be in English language or translation need to be submitted)Quality certificates including ISO Certificate, EC certificate etc, Approval issued by other NRAs (National Regulatory Authorities) to prove export sale (Eg : US FDA, EUA approval) if available
Proforma Invoice/Commercial Invoice
Label and other supportive documents (Color scanned Immediate and Outer pack)Any other relevant document which may be requested by NMRA if necessary

4)   Applications will be proceeded ONLY through online.

5)   Procedure for approval is as follows.

6)    Following main specifications as per the Guideline on COVID-19 Technical Specifications for Personal Protective Equipment and Related IPC supplies issued by the WHO(WHO/2020-nCoV/MedDev/TS/InfDev dated 7 August 2020) should be fulfilled to obtain a Waiver of Registration (WOR) approval for N95 or KN 95 Respirators.

7)    Please note that NMRA will not be able to proceed any application;

8)   which are not submitted according to the above procedure OR with incomplete documents

9)   Time period for processing will be 7 working days after receiving to NMRA.

10)  Maximum quantity allowed for importation is 1Million per week.

Make sure to attach above required documents and send to following Email address: worappnmra@gmail.com

Note: Please refrain from unnecessary communications through telephone calls within the timelines mentioned, allowing NMRA to provide you a fast tract service.

(Date: 04 December 2020)