Submission Copy of
PLANT MASTER FILE
(As per Appendix – I of Medical Device Rules – 2017 )
Of
HAWKLUX INDIA PRIVATE LIMITED
Address : Second Floor, C-110, Sector - 65, Noida,
Gautam Buddha Nagar, Uttar Pradesh - 201301 ( India )
Phone : +91-9911070123
Email : hawkluxindia@gmail.com
Website.: https://www.hawklux.com
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2.INDEX
Sl. No. Description Page No.
1. Cover Page 1
2. Index 2
3. General Introduction 3-6
4. Personnel 7 - 10
5. Premises and Facilities 11 - 13
6. Equipment 14 - 15
7. Sanitation 16
8. Production 17 – 19
9. Quality Assurance 20 - 21
10. Storage 22
11. Documentation 23
12. Medical Device Complaints and Field Safety 24
Corrective Action
13. Internal Audit 25
14. Contract Activities 26
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3.General Introduction
Hawklux India Private Limited is one of the emerging manufacturer of Endoscopy &
Laparoscopy Cameras and Other Medical Devices in India with best-in-class German
technology in collaboration with German OEM Camera manufacturing company. After
having a rich experience of around 10 years in field of Sales and Distribution of medical
equipment’s, Company expands itself into manufacturing and Trademark its Brand name
“HAWKLUX”
The Corona Pandemic make us realise the need of the revolution in the medical field in our
country. In early 2022 started our new journey to facilitate our Doctors and Hospitals with
medical equipment’s at very competitive and reasonable price. Our Vision is to make all the
hospitals of our country equipped with best medical devices and other surgical instruments,
so every common man can get best in class medical services at their respective local area
hospitals.
Right from its inception, the management laid emphasis on high quality medical devices.
Thereafter the Quality management system was conceived & implemented. Which is very
rare to find in India. With trained & experienced staff, we strive for the best quality product
with latest technology and features which other companies fails to provide at cost effective
solution.
To make our products cost effective we are just importing the importing the best in class
lenses & sensor chips and making our products ready locally under Make in India program.
Followings are some of important Information of Organization –
(i) Brief information on the site (including name and address), relation to other sites;
Name : HAWKLUX INDIA PRIVATE LIMITED
Brand Logo :
Address : Second Floor, C-110, Sector - 65, Noida, Gautam Buddha Nagar, Uttar
Pradesh - 201301 ( India )
Phone : +91-9911070123
Email : hawkluxindia@gmail.com
Website.: https://www.hawklux.com
There is no other site is established and operated by Organization. Only this is the Sole
Site, from where the organization operates its’ All Operations.
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(ii) Manufacturing activities : The Organization is a manufacturer of Endoscopy
Camera (Generic Name - Visualization System For Arthroscopic And
Endoscopic Procedure) & Medical LED Light Device (Generic Name -
Surgical Light System) .
(iii) Any other operations carried out on the site : Trading of hospital furniture, o.t.
equipment & light, surgical instrument, lab equipment & consumables, suction
apparatus, anesthesia equipment, icu & nicu care equipment, orthopedic
implants, medical sutures, flexible & rigid endscope, electro surgical generator,
for Which the Trading License ( Form – 42 ) under Medical Devices Rules 2017
has be granted by “The Drug Controlling and Licensing Authority of Uttar
Pradesh” .
(iv) Name and exact address of the site, including telephone, fax numbers, web site
URL and e-mail address :
Name : HAWKLUX INDIA PRIVATE LIMITED
Brand Logo :
Address : Second Floor, C-110, Sector - 65, Noida, Gautam Buddha Nagar,
Uttar Pradesh - 201301 ( India )
Phone : +91-9911070123
Email : hawkluxindia@gmail.com
Website.: https://www.hawklux.com
(v) Type of medical devices handled on the site and information about specifically toxic
or hazardous substances handled, mentioning the way they are handled and
precautions taken :
The Organization has following two of its’ Products under Manufacturing –
Sl. Medical Device Name Class of Device as Notified Category
No. per MDR 2017
1. Endoscopy Camera (Generic Class A Others General Hospital
Name - Visualization System For / Orthopaedic
Arthroscopic And Endoscopic Instruments
Procedure)
2. Medical LED Light Device Class A Medical Devices
(Generic Name - Surgical Light Pertaining to Operation
System) . Theatre
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For Hazard Substances use , the organization use the only one Hazard Item, for General
Cleaning purpose only.
Sl. Hazard Item Max. Qty. Provision of Remark
No. stored Control of
Substance
storage and
protection
1. Etyle Alcohol (Ethanol) 100 ml As per Material
Safety Data
Sheet provided
by
Manufacturer
-- -- -- -- --
(vi) Short description of the site (size, location and immediate environment and other
activities on the site) :
Total Covered Area : 1300 Sq. Ft.
Location : C-Block, Sector 65, Noida, Gautam Budh Nagar, Uttar Pradesh
Environmental Activities : Nil , No Pollutant Generation and No Stack Emission.
Other Activities : Nil apart of Manufacturing of Endoscopy Camera (Generic Name
- Visualization System For Arthroscopic And Endoscopic Procedure) &
Medical LED Light Device (Generic Name - Surgical Light System) and Trading of
hospital furniture, o.t. equipment & light, surgical instrument, lab equipment &
consumables, suction apparatus, anesthesia equipment, icu & nicu care
equipment, orthopedic implants, medical sutures, flexible & rigid endscope,
electro surgical generator, for Which the Trading License ( Form – 42 ) under
Medical Devices Rules 2017 has be granted by “The Drug Controlling and
Licensing Authority of Uttar Pradesh”
(vii) Number of employees engaged in production, quality control, warehousing, and
distribution :
(viii) Use of outside scientific, analytical or other technical assistance in relation to the
design, manufacture and testing :
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Yes, The Third Party NABL Accredited ( ISO 17025:2017 ) Third Party Laboratories are used
for Performing the Calibration of Measuring Gauges and Product testing as per
requirements.
(ix) Short description of the quality management system of the company :
For Quality Management System, the Organization has implemented the Medical Devices –
Quality Management System as per International Standard of ISO 13485:2016 and is
Certified from an Accredited Certification Body “ LMS Certification Limited” which is a Third
Party Certification Body , Accredited from “Korea Accreditation Board” under the
Membership of “The International Accreditation Forum (IAF) Multilateral Recognition
Arrangement (MLA)”
(x) Devices details registered with foreign countries :
The Organization Operates its’ Business in India Only and there is No Such Registration
within any Foreign Countries are available.
(xi) Brief description of testing facility:
For General Testing of Medical Devices manufactured , the followings Calibrated measuring
gauges are used -
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4. Personnel
(i) Organisation chart showing the arrangements for key personnel
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(ii).Qualifications, Experience and Responsibilities of key personnel :
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(iii) Outline of arrangements for basic and in-service training and how records are
maintained :
For Training includes Basic Training, Onjob Trainings , In-Service Trainings and
Class Room Trainings, the Documented Procedure of “Human Resources - Training”
No. PM-HR-01 Rev. 01 Effect. 01.03.2022 is implemented, and Respective Records of
Trainings are used to maintain and retain.
(iv) Health requirements for personnel engaged in production :
Since, there is no Hazardous, Toxic of Health affecting Substances are used in
any process, thus there is no potential for Health Affection. Also to maintain
the Ergonomic aspects of health, the Fully Air condition Office and Shop Floor is
equipped with Comfortable Seating arrangement with proper light intensity.
(v) Personnel hygiene requirements, including clothing :
Since, there is no Hazardous, Toxic of Health affecting Substances are used in
any process, and also no Micro level ( PCB Assembly Level ) Electronic
Assemblies are used to done where Electro-Static Discharge may affect in any
manner, thus there is no Specific Clothing is required.
Also to maintain the Personnel Hygiene, the Rubber hand Gloves and Apron are
provided to Production Operators.
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