The National Medicines Regulatory Authority is committed to ensure the availability of real time PCR diagnostic tests for Covid-19 in Sri Lanka. To address the urgent need for detection of Covid-19 infection, NMRA has established a temporary Waiver of Registration (WOR) process in line with provisions of section 109 of the NMRA Act. NMRA has worked with the support of Sri Lanka College of Microbiologist and Medical Research Institution (MRI) to ensure the quality of test kits before issuing such waivers of registration. This has helped expand the number of diagnostic tests available in Sri Lanka.

1. Real Time PCR test kits :
Based on the recommendation of the President, Sri Lanka College of Microbiologists, the NMRA shall follow the below mentioned criteria to issue WOR for Real time PCR test kits.

i. The NMRA shall request for the following mandatory documents:

a. Letter of appointment issued by the manufacturer
b. Copy of business registration issued to the local importer
c. Free Sale Certificate / other type of approval with summery evaluation sheet issued by health authority
d. ISO certificate for manufacturing site
e. Manufacturer's EC declaration and EC Quality Assurance System Certificate (CE)
f. List of countries and evidence from one of the reference countries of NMRA (USA, Australia, Canada, Japan, Switzerland, Germany, France, Italy, Sweden, Norway, and Netherland). This is applicable only for manufacturer from non-reference country.
g. Certificate of Analysis (COA) for finished product including the quality of primers and probes
h. Manufacturers specifications and test method
i. Scanned outer pack and label of primary pack
j. Product Information Leaflet (PIL)
k. Performance report from government institute and distribution details (mandatory for second consignment)
l. Invoice

ii. NMRA may issue a WOR after review of the above-mentioned documents;

• if the manufacturer is from a NMRA reference country or market authorization evidence submitted is from NMRA reference country, or
• for products that are listed in the update on COVID-19 in vitro diagnostics listed by National Regulatory Authorities published IMDRF jurisdictions or WHO April 2020, Medical Devices Newsletter: COVID-19.

However:
• If the manufacturer is from non - reference country and there is no evidence submitted to the NMRA from reference countries,
- NMRA shall not issue waiver of registration and may issue a sample licence for importing samples for testing.

- Samples should be tested for quality/performance by an accredited institution acceptable to the NMRA
- Based on a satisfactory test report NMRA may issue a WOR

2. For Rapid test kits :

i. NMRA does not issue WOR for rapid antibody tests at present.
ii. However, the quality/performance of samples submitted to the NMRA will be evaluated. Accordingly, NMRA only issues sample import licence for rapid antibody test kits at present.
iii. Quantity for samples required will be based on the recommendation provided by the Sri Lanka College of Microbiologists.
iv. Samples should be tested in an accredited institution accepted by NMRA for quality /performance testing.
v. The NMRA shall request for the submission of the following mandatory documents:

a. Letter of appointment issued by the manufacturer
b. Copy of business registration issued to the local importer
c. Free Sale Certificate
d. ISO certificate for manufacturing site
e. Manufacturer's EC declaration and EC Quality Assurance System Certificate (CE)
f. If the test kit is manufactured in a non-reference country a list of countries where the product is marketed along with evidence of market authorization in at least one reference country should be provided.
g. Scanned outer pack and label of primary pack
h. Manufacturers specifications and test method
i. Product Information Leaflet (PIL)

vi. After obtaining evaluation reports from testing authorities NMRA shall maintain a list of the products for waivers of registration when the need for these rapid tests is announced by relevant authorities.