Government of Pakistan Sr. No.

1731
Ministry of National Health Services
Regulations & Coordination
Drug Regulatory Authority of Pakistan

FORM-8
[see rule 15(5))
CERTIFICATE OF ENLISTMENT OR REGISTRATION OF A MEDICAL DEVICE
OR ACCESSORY OR COMPONENT FOR LOCAL MANUFACTURE

Licence No. ELM-0032

Date of Issue: 10/11/2020
F.No: 12-117/2020-MD
M/s National Electronics Complex of Pakistan
Plot 23, Street 6, Sector H-9/1, Islamabad.
Al Lab NECOP, Plot 23, Street 6, Sector H-9/1, Islamabad

The medical device as per details given below has been registered or enlisted under the DRAP Act, 2012 and
the rules made there-under subject to the conditions appearing hereinafter:

EnlistmenV Name of Brief Class Shelf life

Registration medical description
No. device or
accessory
or
component

(1) (2) (3) (4) (5)

MDMR-000099 COV-RAID COV-RAID Is a Windows based B N/A
(COVID-19 Rapid software program based on python
Artificial Intelligence using TensorFlow and Keras
Detection) libraries. it shall employ
Convolulional Neural Networks to
predict Covid-19 in suspected
individuals. The purpose is to
identify suspected patients
economically using X-Rays. The
product Is approved for secondary
detection of COVID-19.

Name and complete address of manufacturer: (

M/s National Electronics Complex of Pakistan

Plot 23, Street 6, Sector H-9/1, Islamabad

Drug Regulatory Authority of Pakistan• TF Complex G9/4, Islamabad Pakistan. Ph. +92 51 9262180, 051, +92 51 9107402
Page 112
 Sr. No. _____
1730
Government of Pakistan
Ministry of National Health Services
Regulations & Coordination
Drug Regulatory Authority of Pakistan

FORM-3
{see rule 5(2))
LICENCE TO MANUFACTURE MEDICAL DEVICES

Licence No. ELM-0032

Date of Issue: 09/11/2020
F.No: 12-117/2020-MD
Mis National Electronics Complex of Pakistan, Is hereby licensed to manufacture medical devices at the
following premises: Address of Manufacturer: Plot 23, Street 6, Sector H-911, Islamabad.
Manufacturing Site Address; Al Lab NECOP, Plot 23, Street 6, Sector H-9/1, Islamabad.

2. This licence permits the manufacture of following medical devices

S.No Name or Medical Device

1 COVID related artificial Intelligence based software
3. This licence shall, In addition to the conditions specified in the Medical Devices Rules. 2017 made
under the DRAP Act. 2012, be subject 10 the following conditions namely:-
(a) The licence shall be in force for a period of five years from the date or issue unless earlier
suspended or cancelled.
(b ) The licence authorizes the sale by way of wholesale dealing and storage for sale by lhe
licensee or the products manufactured under this licence, subject 10 the condltlons
applicable lo licences for sale.
(c) Name of the approved qualified technical staff.

Mr. Muhammad Ajmad Mr. Umalr Hammad

Biomedical Engineer Biomedical Engineer
Production lncharge Quality Control lncharge

Renewal Date: 08/11/2025

DNg Regul•lory Aulhorlty or P•klsl>n. TF Compl•� G9/4, lsl•m•b>d Pakl$Un • Ph. •92 51 9262180, 051, •92 51 9107402
Paga Ill
I.