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Annex 1 Application for CPR - Healthcare Waste Treatment Equipment

FDA application form for registration of equipment/devices use to treat sharps, pathological and infectious waste.

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Revision No. 01 Date Effective: 01 January 2018

APPLICATION FOR REGISTRATION OF EQUIPMENT/DEVICES USED TO TREAT
SHARPS, PATHOLOGICAL AND INFECTIOUS WASTES
New Application

Renewal

I. Applicant Description
Name of Company: _________________________________________________________________
Office Address: ____________________________________________________________________
Plant Address: _____________________________________________________________________
Tel. No. _______________Telefax No. ___________________ Email Address: _________________
Company TIN:_____________________________________________________________________
Name of Chief Executive Officer (CEO) : ________________________________________________
Name of Company Representative: _____________________________________________________
Position/Designation: ________________________________________________________________
II. Business Activity Description
Manufacturer / Distributor / Importer
Service Provider with TSD Facility
Healthcare Waste Generator (Hospital, clinic, birthing homes, infirmaries, laboratories)
Capital Investment:
Capitalization (Total Cost of Equipment)_________________________________________________
Total Number of Emplyees:___________________________________________________________
No. of Hours of operation / day:________________________________________________________
III. Product Description
Type of Treatment Technology
Autoclave
Hydroclave
Microwave
Pyrolysis
Chemical Disinfection
Others
PRODUCT
BRAND
DESCRIPTION
CLAIMS
_________________ ________________ ____________________
________________
_________________ ________________ ____________________
________________
Use additional sheet if necessary)

Capacity of the Equipment / Device (in kg/day):___________________________________________
Type of healthcare waste treated (sharps, infectious, pathological etc)__________________________
__________________________________________________________________________________
Weight of the waste treated per batch (kg)________________________________________________
Weight of waste treated per day (kg):____________________________________________________
Type of Disposal:
Sanitary Landfill
Private Dumpsite
Controlled Dumpsite
Others
Location of Disposal Facility:_________________________________________________________
I hereby certify that all the information given above and all other data in connection with this application
are true and correct. I understand that any misrepresentation or false information will be ground for
outright rejection of my application for registration of equipment/devices used to treat sharps,
pathological and infectious wastes. I am also authorizing representatives from CDRRHR-LRD to
conduct verification of all the documents attached herewith and inspection of the above-stated products
as may be deemed necessary. Furthermore, I understand that my application will not be processed until
after I have completely submitted all the requirements enumerated in this application form.

Signature of Company Representative over Printed Name

Date
 
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