______________________________________________________________________________________________________________  
Building I, San Lazaro  Compound , R izal Av·enue, Sta .Cruz, 1003 Mani  la • Trunk  Line  651-7800 • Direct Line: 7 1 1-9501 
Fa x: 743-1829, 743-1786 • URL: http://www.doh.gov.ph  • e-mail: osec@doh.gov.ph                                                                                                                                                                                                                                                                                                                                                                                                                        
 
 
 
ADMINISTRATIVE ORDER No. ________________  
SUBJECT:  Guidelines on the Issuance of an Authorization for Equipment or 
Devices Used for Treating Sharps, Pathological and Infectious Waste  
________________________________________________________________________  
 
I. RATIONALE / BACKGROUND  
The Department Environment and Natural Resources (DENR) and the Department 
of Health (DOH) issued Joint DENR -DOH Administrative Order No. 02 series of 2005 to 
provide guidelines on the management of health care wastes relative to the Implementing 
Rules and  Regulations (IRR) of Chapter XVIII – “Refuse Disposal” of the Code on 
Sanitation of the Philippines (P.D. 856).   
The Joint DENR -DOH Administrative Order mandated the DOH to require all 
health care waste treatment, storage, disposal (TSD) facility operato rs and health care 
waste generators with on -site waste treatment facilities to use DOH registered equipment 
or devices used for treatment of health care wastes.  
On 14th March 2007, Administrative Order No. 2007 -0014 was issued by the 
Secretary of Health t hrough the Bureau of Health Devices and Technology (BHDT) to 
provide guidelines on the rules and regulations with respect to registration, monitoring and 
evaluation of devices and equipment used in the treatment of sharps, pathological and 
infectious waste s.  
Republic Act 9711, otherwise known as the “Food and Drug Administration (FDA) 
Act of 2009” through its IRR enhance, strengthen and rationalize the regulatory systems 
for establishment and products under its jurisdictions.  
 
To effectively implement the  above provisions on the regulations of all devices and 
equipment used in the treatment of sharps, pathological and infectious wastes in the 
Philippines, the FDA - Center for Device Regulation, Radiation Health, and Research 
(CDRRHR) (formerly BHDT) hereby issues this Administrative Order.  
II. OBJECTIVE  
This Administrative Order aims to enhance and strengthen the existing rules and 
regulations of the FDA -CDRRHR relative to the safety, efficacy and quality of equipment 
or devices used for treating sharps, pat hological and infectious wastes.  Republic of the Philippines  
Department  of Health 
OFFI CE OF THE SECRETARY  
 
 
III. SCOPE  
This Administrative Order shall apply to all manufacturers, importers, distributors, 
traders, exporters, healthcare waste generators and Treatment Storage and Disposal 
Facilities of equipment or devices used for treating sharps, pathological and infectious 
wastes.  
IV. DEFINITION OF TERMS   
1. AUTHORIZATION –  means a permission embodied in a document granted by the 
FDA to a natural or juridical person who has submitted an application to implement the 
manufacture, importation, exportation, sale, offer for sale, distribution transfer, and or 
where appropriate, the use, testing, promotion, advertising, or sponsorship of health 
products. The authorization can take the form of a permit, a license, a certificate of 
regis tration, of accreditation, of compliance, or of exemption or any similar document.  
 
2. AUTOCLAVE – an equipment using  steam under pressure and temperature for 
effective sterilization.  
 
3. CHEMICAL DISINFECTION – refers to the treatment process where chemicals 
like aldehydes, chlorine compounds, phenolic compounds, etc. are added to waste in 
order to kill or inactivate pathogens present in healthcare waste.  
 
4. DISTRIBUTOR/IMPORTER/EXPORTER – means any establishment t hat imports 
or exports raw materials, active ingredients and/or finished products for its own use or 
for wholesale distribution to other establishments or outlets. If the 
distributor/importer/exporter sells to the general public, it shall be considered a r etailer.  
 
5. DISTRIBUTOR/WHOLESALER – means any establishment that procures raw 
materials, active ingredients and/or finished products from a local establishment for 
local distribution on wholesale basis.  
 
6. DEVICE – for the purpose of this order it  refers to equipment or devices used to treat 
sharps, pathological and infectious waste.  
 
7. ESTABLISHMENT – means a sole proprietorship, a partnership, a corporation, an 
institution, an association, or an organization engaged in the manufacture, importation, 
exportation , sale, offer for sale, distribution, donation, transfer, use, testing, promotion, 
advertising, or sponsorship of devices used to treat sharps, pathological and infectious 
wastes, including the facilities and installation needed for its activities.  
 
8. HEALTH CARE FACILITIES  - for this purpose, are public, private and non -
governmental institutions/facilities that contribute to the improvement of the health 
status of an individual.  
  
 
 9. HEALTHCARE WASTES – include all wastes generated as a result of the  following:  
 
 Diagnosis, treatment or immunization of human beings;  
 Research pertaining to the above activities;  
 Research using laboratory animals for the improvement of human health;  
 Producing or testing of biological products; and  
 Other activities performed by HCF.  
 
10. HEALTHCARE WASTE GENERATOR - shall refer to health care facilities, 
institutions, business establishments and other similar health care services with 
activities or work processes that generate health care waste. (Please see Annex A)  
 
11. HYDROCLAVE – an equipment similar to autoclave where steam, heat and pressure 
are used for sterilization.  
 
12. INFECTIOUS WASTE – shall refer to type of waste suspected to contain pathogens 
(bacteria, viruses, parasites or fungi) in sufficient concentration or quantity to cau se 
disease in susceptible.  
 
13. ITDI -DOST – refers to the Industrial Technology Development Institute of the 
Department of Science and Technology.  
 
14. LGU – refers to the Local Government Units.  
 
15. LICENSING  - means the process of approval of an application to operate or establish 
an establishment prior to engaging in the manufacture, importation, exportation, sale, 
offer for sale, distribution, transfer, and where applicable the use, testing, promotion, 
advertisement, and/or sponsorship of health products.  
 
16. MANUFACTURER – in relation to a health product, means an establishment engaged 
in any and all operations involved in the production of health products including 
preparation, processing, compounding, formulating, filling, packaging, repackaging, 
altering, or namenting, finishing and labeling with the end in view of its storage, sale or 
distribution: Provided, That the term shall not apply to the compounding and filling of 
prescriptions in drugstores and hospital pharmacies. A trader shall be categorized as a 
manufacturer.  
 
17. SAFETY DATA SHEET (SDS) - formerly (MSDS) , provide useful information on 
chemicals, describing the hazards the chemical presents, and giving information on 
handling, storage and emergency measures in case of an accident.  
 
18. MICROWAVE – refers t o a technology that typically incorporates some type of size 
reduction device. Shredding of wastes is being done before or after disinfection. In this 
process, waste is exposed to microwaves that raise the temperature to 1000C for at least  
30 minutes. Micr oorganisms are destroyed by moist heat that irreversibly coagulates 
and denatures enzymes and structural proteins.  
 
19. NRL -EAMC – refers to the National Reference Laboratory for Environmental and 
Occupational Health, Toxicological and Micronutrient Assay – East Avenue Medical 
Center.  
 
20. PATHOLOGICAL – refers to tissue sections and body material derived from biopsies 
or surgical procedures that are then examined in the laboratory.  
 
21. FORMANCE TESTING / EVALUATION  – refers to the test being done by NRL -
EAMC and the ir designated laboratories to verify compliance to the test criteria set by 
the NRL -EAMC or to the data submitted by the applicant.  
 
22. PYROLYSIS – refers to the thermal decomposition of substance and materials in the 
absence of supplied molecular oxygen in the destruction chamber in which the said 
material is converted into gaseous, liquid or solid form.  
 
23. REGISTRATION – refers to the process of appr oval of an application to register 
devices prior to engaging in the manufacture, importation, exportation, sale, offer for 
sale, distribution, transfer, and where applicable the use, testing, promotion, 
advertisement, and/or sponsorship of devices.  
 
24. SHARPS  – shall include needles, syringes, scalpels, saws, blades, broken glass, 
infusions sets, knives, nails and any other items that can cause a cut or puncture 
wounds.  
 
25. TRADER – means any establishment which is a registered owner of a health product 
and procu res the raw materials and packing components, and provides the production 
monographs, quality control standards and procedures, but subcontracts the 
manufacture of such product to a licensed manufacturer. In addition, a trader may also 
engage in the distri bution and/or marketing of its products.  
 
26. TREATMENT, STORAGE AND DISPOSAL (TSD) FACILITIES – refers to 
facilities where hazardous waste are stored, treated, reprocessed and/or disposed of, as 
prescribed under current DENR pertinent policies.  
 
V. POLICIES AND  GUIDELINES  
 
A. GENERAL GUIDELINES  
 
1. All establishments shall secure appropriate authorization from the FDA prior to 
manufacture, importation, exportation, sale, offer for sale, distribution, transfer, use, testing, 
promotion, advertising, or sponsorship of devices used to treat sharps, pathological and 
infectious wastes.   
 
 2. All applicants shall follow current rules, regul ation and guidelines of the FDA in the 
submission of LTO and CPR application.  
 
3. The LTO and CPR shall be issued by the CDRRHR upon the approval of the Center Director 
or his/her authorized representative if the application is found to be meritorious; otherw ise, 
the application shall be disapproved.  
 
4. All establishments shall operate based on the activities specified in their issued LTO . 
 
5. All TSD, healthcare waste generators and facilities with on -site facilities treatment shall use 
only FDA registered devices.  
 
6. The following are the approved technologies or processes that maybe used in the treatment 
of sharps, pathological and infectious wastes:  
 
i. Autoclave  
ii. Hydroclave  
iii. Pyrolysis  
iv. Microwave  
v. Chemical Disinfections  
 
7. For technologies or processes used in the treatment of sharps, pathological and infectious 
waste not mentioned above, a technology approval shall be secured at the ITDI -DOST first 
before applying for registration.  
8. The NRL -EAMC and its designated labo ratories shall conduct the performance 
testing/evaluation of devices prior to its initial and renewal registration. The results of the 
performance evaluation shall be valid for three (3) years.                                                                                                                                                   
VI  SPECIFIC GUIDELINES  
A. License to Operate (LTO)  
 
1. All local manufacturers, distributors, importers, exporters, wholesaler and traders shall 
apply for a LTO before engaging in the manufacture, importation, sale, offer for sale, 
and distribution of device.  
 
2. All establishments shall apply for LTO through FDA electronic portal (e -portal). 
Accessing the FDA e -portal to file for an LTO application, wheter initial, renewal or 
varia tion/s, shall be required to have an authorized User Account to be provided by the 
FDA Action Center (FDAAC) via email.  
 
3. Establishments whose applications have deficiencies shall be notified and be given 
thirty (30) calendar days  compliance period to correct the deficiencies; otherwise the 
application shall be disapproved. A notice shall be sent to the establishment stating the  
reason for the disapproval of their application for LTO. The establishment may re -apply 
for an LTO by su bmitting the required documents and paying the prescribed fees.  
 
4. For renewal  applications  filed within one hundred twenty (120) days from its original 
expiry  date, the LTO shall be considered valid and existing until a decision or resolution 
by the FDA is rendered on the application for renewal. (see Annex B for documentary 
requirements)  
 
5. Establishment shall follow the current provisions of variations stipulated in AO 2016 -
0003 (Guidelines on the Unified Licensing Requirements and Procedures of the Food 
and Drug Administration).  
 
B. Certificate of Product Registration (CPR)  
 
1. All local manufacturers, importers, distributors and traders, shall apply first for an LTO 
before applying for a Certificate of Product Registration (CPR) of device . 
 
2. The following shall be  exempted from registration requirements:  
 
a. Manufacturers / distributors and suppliers of equipment and devices used to treat 
sharps, pathological and infectious waste that are not being marketed or 
commercially distributed and being used in the Philippines . 
b. Autoclaves and sterilizers in hospital laboratories, dermatology and dental clinics 
that are used only to sterilize surgical instruments, needles, hand  pieces and the 
like. 
 
3. All applications with deficiencies shall be given a one -time compliance period of 
maximum of ninety (90) calendar days. If the deficiencies were not complied during 
the above stated period, the application shall be considered disapproved. However, the 
applicant may opt to submit a re -application within sixty (60) calendar days after the 
disapproval. If no compliance is received within the set compliance period, the 
application shall be automatically considered disapproved.  
 
4. An application for renewal filed after one hundred twenty (120) calendar days after its 
expiration shall not be accepted and shall be considered an initial application. The 
distribution and sale of device shall automatically stop until such time that CPR have 
been approved. The applicant cant opt, however, to request the retention of the product 
registration/notific ation number.  
 
5. The application for renewal shall be evaluated within thirty (30) days upon filing of 
the application. All applications that do not comply with the technical requirements 
shall be notified through a letter and shall be given a one -time chanc e to correct the 
deficiencies within thirty (30) days.  
 
6. Upon compliance to the preliminary evaluation of the documents the application shall 
be indorsed to the NRL -EAMC for performance evaluation. The FDA may conduct  
 
 inspection at any given time in coordin ation with the LGUs and other government 
agencies as maybe deemed necessary.  
 
7. Amendment for CPR shall be allowed for business name and address requirements 
specified in Annex B.  
 
8. A change in design / technical specifications that would significantly affect  the quality 
and performance of the device such as but not limited to operating pressure, 
temperature, time of treatment shall mean revocation of the previously issued 
registration. The establishment has to apply for a new CPR for the device and has to 
comply with the requirements for initial application of a CPR.  
 
C. Documentary Requirements  
 
 The requirements for the issuance of LTO and CPR (initial and renewal 
applications). The amendments are specified in Annex B and C respective ly of this 
Administrative Order.  
 FDA may request for additional documents not specified in Annex B and C if 
deemed necessary.  
D. Validity  
 
 The LTO issued by the CDRRHR Director under the authority of the FDA Director 
General, is valid for three (3) years from the date of issuance and subject to renewal unless 
sooner suspended/revoked or cancelled after due process, in accordance with RA 9711 
and/or other pertinent rules and regulations.  
 The CPR  issued by the CDRRHR Director under the authority of the FDA Director 
General, is valid  for one (1) year from the date of issuance and subject for renewal unless 
sooner suspended/revoked or cancelled after due process, in accordance with RA 9711 
and/or other pertinent rules and regulations.  
VII.  FEES AND OTHER CHARGES  
 
Payment of initial an d renewal application fees and other charges (surcharges, 
penalties and legal research fund fees) shall be collected as maybe allowed subject to the 
existing rules and regulations of the FDA.  
 
VIII. GROUNDS FOR , CANCELLATION OR SUSPENSION OF LICENSE  AND/OR  
REGISTRATION  
The following shall be grounds for, cancellation or suspension of license and/or registration:  
  
1. Non-compliance with the standards and guidelines of the FDA and other concerned 
agencies such as the NRL -EAMC, Department of Environment a nd Natural Resources – 
Environmental Management Bureau (DENR -EMB), etc.;  
2. Material misrepresentations, misbranding, and/or falsifications of the documentary 
requirements, licenses, registrations or any appropriate authorizations;  
3. Violation of any of the ter ms and conditions of its licenses, registration or authorization;  
4. Change in ownership or management of an establishment not reported in the FDA; and  
5. Such other analogous grounds or causes as determined by the FDA.  
 
IX.  INSPECTION / COMPLIANCE MONITORING  
 
The FDA shall conduct inspection /compliance monitoring of establishments to 
over sight and audit of related researches that would ensure safety, quality, purity and 
efficacy of health care waste treatment.  
 
X. TRANSITORY PROVISIONS  
Establishments that m anufacture, import and/or distribute devices used to treat 
sharps, pathological and infectious wastes including TSD facility operators and health care 
waste generators shall be given a grace period of six (6) months from the effectivity of this 
Order to co mply with the provisions of this guideline.  
LTO and CPR are still valid provided that they will apply and shall be given six (6) 
months from the effectivity of this Order to comply with the provisions of this guideline.  
XI.   PENALTY  CLAUSE  
Sanctions over violations of any of the provisions of this Administrative Order shall 
follow the Rules of Administrative Procedure provided in the implementing rules and 
regulations of Republic Act No. 9711.  
XII.  SEPARABILITY CLAUSE  
In the event that any rule, section, paragraph, sentence, clause or words of these 
rules and regulations is declared invalid for any reason, the other provisions thereof which 
are valid shall not be affected.   
XIII.  REPEALING CLAUSE  
Provisions from AO2007 -0014 and all other issuances that a re inconsistent with 
this Order shall be repealed accordingly.  
  
 
 XIV.  EFFECTIVITY  
This Administrative Order shall take effect fifteen (15) days following the 
completion of its publication in two (2) newspapers of general circulation and submission 
to the University of the Philippines Law Center.  
 
     
 
                            FRANCISCO  T. DUQUE III, MD , MSc  
                                            Secretary of Health  
 
 
Food and Drug Administration  Office for Health R egulation  Health Policy Development and Planning 
Bureau  Office of the Secretary  
 
 
 
 
NELA CHARADE G. PUNO , 
RPH  
Director General   
 
 
 
DR. ROLANDO ENRIQUE D. 
DOMINGO, MD, DPBQ  
Undersecretary of Health   
 
 
 
DR. KENNETH G. RONQU ILLO, 
MPHM, CESO III  
Director IV   
 
 
 
ATTY. FATIMA P. 
LAPERAL  
Head Executive Assistant  
Date:  Date:  Date:  Date:  
 
Keywords  Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste  
Related issuances, laws, 
directives  Joint DENR -DOH Administrative Order No. 02 series of 2005 to provide guidelines 
on the management of health care wastes relative to the Implementing Rules and 
Regulations (IRR) of Chapter XVIII – “Refuse Disposal” of the Code on Sanitation 
of the Philippines (P.D. 856)   
 
 
 
 
 
 
 
  
Annex A  
 
Healthcare Facilities (HCF) - which includes:  
 
1. Hospitals (Primary Care, Secondary Care and Tertiary Care)  
 
2. Infirmaries  
 
3. Birthing Homes  
 
4. Clinics  
 
 
 
 
 
 
 
 
5. Laboratories and Research Centers  
       
[a] Medical and biomedical  
      Laboratories  [e] Nuclear medicine laboratories  
 
[b] Medical research centers      [f] Biotechnology laboratories  
[c] Blood bands and blood collection  
      services  [g] Animal research and testing  
 
[d] Dental prosthetic laboratories  
 [h] Drug testing laboratories  
 
 [i] HIV testing laboratories  
 
6. Drug Manufacturers  
 
7. Institutions  
       
[a] Drug rehabilitation center  [d] Schools of Radiologic Technology  
[b] Training centers for embalmers  [e] Medical Schools  
[c] Med -tech intern training centers  [f] Nursing Homes  
 [g] Dental Schools  
 [a] Medical                                                     [e] Surgical                                       
[b] Ambulatory                                               [f] Alternative medicine   
[c] Dialysis                                                     [g] Dental  
[d] Health care centers and  
      dispensaries                             [h] Veterinary   
 
 8. Mortuary and Autopsy Centers  
       
Annex B  
Documentary Requirements for initial application of a License to Operate  
1. Duly accomplished application form  
 
a. Declaration and undertaking of the responsibilities of the applicant as a condition for 
the processing and approval of the LTO;  
b. The location plan and global position system (GPS) coordinates of the establishment;  
c. The name of the qualified  person per type of establishment, and the relevant credentials 
(e.g. PRC ID)  
d. The names of the following personnel shall also be listed:  
i. Production Manager/Head  
ii. Quality Assurance Manager/Head  
iii. Quality Control Manager/Head  
 
2. Proof of Business Registration  
 
a. Single Proprietorship  
 
Valid Certificate of Business Name Registration with the Department of Trade and 
Industry indicating the same name, address and ownership as the establishment applying 
for a license.  
 
b. Corporation or Partnership  
 
i. Valid Registration with Securities and Exchange Commission (SEC) indicating the same 
name, address and ownership as the establishment applying for a license.  
ii. Articles of Incorporation  
 
c. Cooperative  
 
Valid Certificate of Cooperative Development Authority (CDA) indicating the 
same name, address and ownership as the establishment applying for a license.  
d. Government -owned or controlled corporation  
 
The law creating the establishment, if with original charter, or its Certificate of 
Registration issued by the Securities and Exchange  Commission (SEC) and Articles of 
Incorporation, if without original charter  
  
Note : If the business name and/or address is different from the registered name and/or address 
in the issued DTI, SEC or CDA certificates, the following shall be submitted in add ition 
to the documents mentioned above:  
 
i. SEC Certificate containing the phrase “Doing business under the name and style of 
(Name of Establishment)”. – applicable for Corporations and Partnerships  
ii. Valid Mayor’s Business Permit indicating the same name, addr ess and ownership as 
the establishment applying for a license.  
 
3. Supplementary requirements for:   
a. Manufacturers  
 
i. Layout of the Manufacturing Plant  
ii. Technical Description of the Manufacturing process  
iii. Proposed product labels and other marketing materials  
iv. List of existing clients / buyers  
v. The name of the facility/safety engineer or any other qualified professional who has 
knowledge in the equipment/devices used for the treatment of health care wastes, and 
the relevant credentials (e.g. PRC ID)  
 
b. Importer / Distributor  
 
i. Profile of the company where the device was imported  
ii. Import permit  
iii. List of distributors  
 
4. Risk Management Plan (contingency plan)  
 
A general Risk Management Plan (RMP) for the establishment must be submitted and 
contain details on how to identify, characterize, prevent or minimize risk relating to the device that 
the establishment is engage with.  
 
5. Proof of payment  
 
Documentary Requirements for Renewal of License  
 
a. Duly accomplished application form  
b. Photocopy of previously issued license  
c. Affidavit of Continuous Compliance  
d. Proof of payment  
 
Require ments for Amendment of a License  
a. Duly accomplished application form;   
 
 b. Letter stating the changes/amendments to be made;  
c. New Business name registration from DTI/SEC; If the address registered with the 
DTI/SEC is different from the address in the application form, a photocopy of the valid 
Mayor’s Permit should be submitted.  
d. Proof of payment  
 
Annex C  
 
Documentary Requirements for initial application of a Certificate of Product Registration  
 
1. Duly accomplis hed application form  
 
2. Copy of LTO for Importer, Distributor, Manufacturer and trader.  
 
Note: for TSD – Hauling/Transport permit from DENR and for Hospital/Healthcare waste 
generator – LTO from DOH -BHFS  
3. Technical Report that includes the following data:  
 
a. Characteristics and Sources of generated waste;  
b. Detailed description of the treatment process;  
c. Technical specifications of the device applied for a CPR;  
d. Operating procedures and conditions including treatment time, pressure, temperature, 
treatment cycle, c hemical concentration, doses, feed rates and waste load composition 
whichever is applicable;  
e. Storage, handling and volume capacity;  
f. Technical description of accessories attached to the device such as shedders, boilers 
etc.;   
g. Applicable emission controls f or suspected emission;  
h. Potential hazards/toxicities of waste residues;  
i. Energy efficiency / electrical requirements;  
j. Occupational safety and health assurance.  
 
4. Operation Manual  
 
5. Maintenance Manual  
 
6. Layout / Plans  
a. Location of installation;  
b. Design / Drawing or picture of the device applied for CPR.  
 
7. Performance Evaluation Report from the NRL -EAMC*  
  
*The Performance Evaluation Report issued by the NRL -EAMC is not submitted when filing 
for initial application. The said report shall be forwarded by NRL -EAMC to t he CDRRHR 
after the conduct of the performance evaluation of the device. The NRL -EAMC shall 
conduct the product performance testing after receiving the endorsement letter from the 
CDRRHR and shall inform the latter of the action taken within thirty (30) ca lendar days 
from the receipt of the endorsement letter.  
 
Documentary Requirements for Renewal of Registration  
 
1. Duly accomplished application form  
2. Affidavit of Continuous Compliance  
3. Copy of LTO  
4. Proof of payment  
 
Requirements for Amendment of Registration  
a. Letter stating the changes/amendments to be done;  
b. New business name registration from DTI/SEC; if the address registered with the DTI/SEC 
is different from the address in the application form, a photocopy of the valid Mayor’s 
Permit should be submitted;  
c. Notarized affidavit stating that the no change was made with regards to the design or 
technical specifications of the device; and  
d. Proof of payment.