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Annex 2 Annex 2 - Checklist Of Requirements for Registration of Equipment Devices

FDA requirement checklist for registration of equipment devices used To treat sharps pathological and infectious wastes

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Revision No. 01 Date Effective: 01 January 2018

CHECKLIST OF REQUIREMENTS FOR REGISTRATION OF EQUIPMENT/DEVICES
USED TO TREAT SHARPS, PATHOLOGICAL AND INFECTIOUS WASTES
A. FOR INITIAL APPLICATION
1.
2.
3.
4.

Properly filled up application form
Copy of SEC Articles of Incorporation or DTI Certificate of Business Registration
Technology Approval from DOST-ITDI for new technologies
Technical Report
4.1 Company profile;
4.2 Characteristics and Sources of generated waste;
4.3 Detailed description of treatment equipment to be tested including manufacturer’s
instructions and technical specifications;
4.4 Operating procedures and conditions including as applicable treatment time, pressure,
temperature, chemical concentration, doses, feed rates and waste load composition;
4.5 Storage, handling and volume capacity;
4.6 Applicable emission controls for suspected emissions;
4.7 Potential hazards/toxicities of waste residues;
4.8 Energy efficiency
4.9 Occupational safety and health assurance.
5. Copy of Operation Manual
6. Layout / Plans
6.1 Location of installation;
6.2 Design / Drawing or picture of the device / equipment applied for;
7. Supplementary requirements for equipment / devices used for chemical disinfection:
7.1 Material Safety Data Sheet (MSDS) of the chemicals to be used for disinfections
7.2 The chemical to be used should be registered with the DENR-EMB or must be compliant
with the WHO guidelines for hazardous wastes.

For healthcare waste generators (e.g. hospitals) and Treatment, Storage and Disposal (TSD)
Facilities, the Environmental Compliance Certificate (ECC) issued by the Environmental Management
Bureau-Department of Environment and Natural Resources (EMB-DENR) and the License to Operate
issued by the Department of Health shall be submitted together with the above documentary
requirements.

B. FOR RENEWAL APPLICATION

1.
2.
3.
4.

Properly filled up application form
Copy of issued CPR
Result of valid Microbiological Tests/Leachate Characteristic Toxicity Test
Location of Installation

Notes:
1.
2.
3.

This office shall not accept applications with incomplete requirements.
All documents should be submitted in electronic copy format.
All information contained in this application form will be held strictly confidential.
 
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