Revised Policies and Guidelines on the “Regulation on the Licensing of Establishments and Registration of Devices for Treating Sharps, Pathological and Infectious Waste in the Philippines”.

  1. I. RATIONALE / BACKGROUND

Pursuant to Chapter XVIII of the Sanitation Code of the Philippines (PD 856) and the Joint Department of Environment and Natural Resources – Department of Health (DENR-DOH) Administrative Order No. 02 series of 2005, the Department of Health through the Bureau of Health Devices and Technology issued and implemented Administrative Order (AO) No. 2007-0014 “Guidelines on the Issuance of Certificate of Product Registration for Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste” to regulate equipment or devices used to treat healthcare wastes.

However, with the implementation of Republic Act 9711, known as the “Food and Drug Administration Act of 2009”, there is a need to amend and supplement the provisions of AO 2007-0014 to further strengthen the capacity of the Center for Device Regulation, Radiation Health and Research (former name: Bureau of Health Devices and Technology) in the regulation of devices used to treat healthcare waste

To effectively implement the above provisions, the FDA through the Center for Device Regulation, Radiation Health and Research (CDRRHR) hereby issues these revised policies and guidelines amending and supplementing AO 2007-0014.

  1. II. OBJECTIVE

This Administrative Order is developed to improve and strengthen the licensing of establishments and device registration requirements of the FDA-CDRRHR relative to the safety and efficacy of devices used for treating sharps, pathological and infectious wastes.

III.       SCOPE

These guidelines shall apply to all local manufacturers, importers, distributors, Treatment Storage and Disposal (TSD) facility operators and users of devices for treating sharps, pathological and infectious wastes in the Philippines.   

  1. DEFINITION OF TERMS          

                        For purpose of this Order, the terms below shall be defined as follows:

  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 registration, of accreditation, of compliance, or of exemption or any similar document.
  1. AUTOCLAVE – refers to the treatment process using steam sterilization to render waste harmless.
  1. CDRRHR – refers to the Center for Device Regulation, Radiation Health and Research of the FDA
  1. 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.
  1. DISTRIBUTOR / IMPORTER / EXPORTER – means any establishment that imports devices 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 retailer.
  1. DEVICE – refers to equipment or devices used to treat sharps, pathological and infectious waste.
  1. 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.
  1. FDA – refers to the Food and Drug Administration.
  1. HEALTHCARE WASTES – include all wastes generated as a result of the following:
  1. Diagnosis, treatment, management and immunization of humans or animals;
  2. Research pertaining to the above activities;
  3. Producing or testing of biological products; and
  4. Waste originating from minor or scattered sources (i.e dental clinics, alternative medicine clinics, etc.)
  1. HEALTHCARE WASTE GENERATORS WITH TREATMENT FACILITY – refers to healthcare facilities, institutions, business establishments and other similar healthcare services with an on-site/off-site treatment facility that stores and treats their generated healthcare wastes containing sharps, pathological and infectious wastes. (Please see Annex A – Types of Healthcare Waste Generators).
  1. HYDROCLAVE – refers to a treatment process similar to the autoclave where steam, heat and pressure are used
  1. INFECTIOUS WASTE – refers to a type of waste suspected to contain pathogens (bacteria, viruses, parasites or fungi) in sufficient concentration or quantity to cause disease in susceptible hosts. This includes:
  • Cultures and stocks of infectious agents from laboratory work;
  • Waste from surgery and autopsies on patients with infectious diseases (e.g. tissues, materials or equipment that has been in contact with blood or other body fluids;
  • Waste from infected patients in isolation wards (e.g. excreta, dressings from infected or surgical wounds, clothes heavily soiled with human blood or other body fluids);
  • Waste that have been in contact with infected patients undergoing hemodialysis (e.g. dialysis equipment such as tubing, filters, disposable towels, gowns, aprons, gloves and laboratory coats);
  • Infected animals from laboratories; and
  • Any other instruments or materials that have been in contact with infected persons or animals.
  1. ITDI-DOST – refers to the Industrial Technology Development Institute of the Department of Science and Technology
  1. LGU – refers to the Local Government Units
  1. LICENSING – refers to the process of approval of an application to operate 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 devices used for treating sharps, pathological and infectious wastes.
  1. MANUFACTURER – means an establishment engaged in any and all operations involved in the production of including preparation, packaging, repackaging, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution.
  1. MATERIAL SAFETY DATA SHEET (MSDS) – refers to a form containing general information on the properties, safety and potential hazards of a particular chemical
  1. MICROWAVE – refers to 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. Microorganisms are destroyed by moist heat that irreversibly coagulates and denatures enzymes and structural proteins.
  1. NRL-EAMC – refers to the National Reference Laboratory for Environmental and Occupational Health, Toxicological and Micronutrient Assay – East Avenue Medical Center
  1. PATHOLOGICAL WASTE – consists of tissues, organs, body parts, human fetus and animal carcasses, blood and body fluids. This category should be considered as a subcategory of infectious waste, even though it may also include healthy parts
  1. PRSDD – refers to the Product Research and Standards Development Division of the CDRRHR
  1. 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
  1. REGISTRATION – refers to the process of approval 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.
  1. RFO – refers to the Regional Field Office of the FDA
  1. SHARPS – shall include needles, syringes, scalpels, saws, blades, broken glass, infusion sets, knives, nails and any other items that can cause a cut or puncture wounds
  1. TREATMENT, STORAGE AND DISPOSAL (TSD) FACILITIES – refers to facilities where hazardous waste are stored, treated, reprocessed and/or disposed of, as prescribed under DENR AO No. 2004-36, Chapter 6-2 (Categories of TSD Facilities) (as defined in section IV “Definition of Terms: in the Joint DENR-DOH Administrative Order No. 02 Series of 2005)
  1. POLICIES ON THE ISSUANCE OF A LICENSE TO OPERATE
  1. General Guidelines
  1. All local manufacturers, importers, exporters, distributors, TSD facility operators and healthcare waste generators with treatment facility shall apply for a License to Operate (LTO) from the CDRRHR before engaging in the manufacture, importation, sale, offer for sale, distribution and use of devices for treating sharps, pathological and infectious wastes.
  1. A single license shall be issued based on the following activities:

2.1 An LTO as Manufacturer shall be issued to establishments engaged in the manufacturing, labelling and assembly of devices.

2.2 An LTO as Distributor/Importer shall be issued to establishments engaged in the importation and/or distribution of devices in the Philippines

2.3 An LTO as TSD Facility Operator shall be issued to facilities under Category B or E of DAO No. 2004-0036 Chapter 6-2 using devices to treat sharps, pathological and infectious wastes

2.4 An LTO as Healthcare Waste Generator with Treatment Facility shall be issued to establishments that store and treat sharps, pathological and infectious waste on-site or off-site using approved technologies and processes (autoclave, microwave, hydroclave, pyrolysis and chemical disinfection).

  1. Establishments shall operate based on the activities specified in their issued license. However, manufacturers, distributors, TSD facility operators and healthcare waste generators may engage in any activity provided that they shall comply with the requirements for licensing for the activities they intend to establish.
  1. An LTO shall only be issued to establishments that comply with the requirements of the CDRRHR and are consistently producing and/or distributing safe and effective devices.
  1. Establishments with valid licenses shall post the LTO issued by the CDRRHR in a conspicuous place in the office premises. Failure to display the valid LTO shall be a ground for the revocation of the license.
  1. Assignment or transfer of a valid and unexpired LTO, or pending application for renewal thereof without any change or variation in the establishment shall be a mere amendment, otherwise, considered initial.
  1. For establishments with revoked/cancelled/suspended LTO resulting from violations of RA 9711 and/or other pertinent regulations shall not be allowed to re-apply for a new LTO for a period of three (3) years and use the same business name.
  1. Documentary Requirements

The requirements for the issuance of an LTO (initial and renewal applications) and its amendments are specified in Annex A of this Administrative Order.

  1. LTO 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.

  1. Specific Procedures
  1. All applications for LTO shall be filed at the CDRRHR office. The CDRRHR will only accept applications with complete requirements including payment of the prescribed fees.
  1. Upon receipt of the application for LTO, the CDRRHR shall conduct preliminary evaluation of the documents, inspection of the office/facility and warehouse and verification of the documentary requirements of the establishment. The technical staff members of the CDRRHR shall inform the representative of the establishment of the findings of the inspection and submit an inspection report upon return to the office.
  1. The approval of the application for LTO by the Director of the CDRRHR under the authority of the Director General of the FDA shall be based on the establishment’s compliance with the requirements of the CDRRHR in accordance with RA 9711 and other relevant rules and regulations.
  1. Establishments whose applications have deficiencies shall be notified and be given thirty (30) calendar days abeyance 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 submitting the required documents and paying the prescribed fees.
  2. POLICIES ON THE ISSUANCE OF A CERTIFICATE OF PRODUCT REGISTRATION
    1. General Guidelines
  3. All local manufacturers, importers, distributors, TSD facility operators and healthcare waste generators with treatment facility shall apply first for an LTO before applying for a Certificate of Product Registration (CPR) of their devices.
  1. All establishments, TSD facility operators and healthcare waste generators with treatment facility are required to apply for a CPR prior to commercial distribution / use if their device used to treat sharps, pathological and infectious waste falls under any of the following conditions:
  1. Already installed and/or in operation prior to the publication of this regulation;
  2. For commercial distribution for the first time, donation or exclusive use by an institution and/or business entity in the Philippines;
  3. Already issued with a CPR but has undergone significant change in design that could affect safety and efficiency.
  4. Uses a technology or process already approved for treatment of sharps, pathological and infectious waste such as but not limited to:
  1. Autoclave
  2. Hydroclave
  • Pyrolysis
  1. Microwave
  2. Chemical Disinfections

 

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 a CPR from this office.

  1. Autoclaves and sterilizers in hospitals, laboratories, dermatology centers and dental clinics that are used only to sterilize surgical instruments, needles, hand pieces and the like are exempted from the registration requirements of this office.

 

  1. A Clearance for Conditional Release shall be issued by the CDRRHR to facilitate the release of the device from the Bureau of Customs (BOC) custody pending the issuance of CPR. The importer shall not sell, distribute or transfer in whole or in part the device used in the treatment of sharps, pathological and infectious waste to any place other than the address specified in the Clearance for Conditional Release. To ensure that no distribution, sale, use and/or transfer of the device was done, the importer shall allow authorized personnel of the CDRRHR to conduct inspection/inventory of the import shipment anytime within official working hours.

 

  1. For companies who wish to register their devices that are not installed or physically present in the Philippines, they may file an application for CPR, however, inspection and laboratory testing of the device shall be conducted in the country where the device was installed. The necessary coordination between the CDRRHR and the concerned government representatives from the country where the device is installed and/or used shall be maintained before, during and after the conduct of the inspection and testing.

 

  1. Documentary Requirements

 

  The requirements for the issuance of a CPR (initial and renewal applications) and its amendments are specified in Annex B of this Administrative Order.

 

  1. CPR Validity

 

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.

 

  1. Specific Procedures

 

  1. Only applications with complete requirements shall be accepted by the CDRRHR. All information must be submitted in English. When the material is not originally in English, an authenticated translation shall be submitted.

 

  1. After the preliminary evaluation of the documents, inspection of the office/facility and warehouse and verification of the documentary requirements of the establishment and no deficiencies were noted, the application shall be indorsed to the NRL-EAMC for laboratory testing. The CDRRHR may conduct inspection at any given time in coordination with the LGUs and other government agencies as may be deemed necessary.

 

  1. The NRL-EAMC and their designated laboratories shall conduct the performance evaluation test of the device applied for CPR. The test shall be done in accordance with the claims of the establishment applying for a CPR. The result of the performance evaluation shall be valid for three (3) years subject to compliance with the applicable standards.

 

  1. Approval and/or disapproval of the CPR shall be based on the establishment’s compliance with the requirements of the CDRRHR and the results of the performance evaluation testing conducted by the NRL-EAMC.

 

VII.  FEES AND OTHER CHARGES

        

Payment of initial and renewal application fees and other charges (surcharges, penalties and legal research fund fees) shall be collected as may be allowed subject to the existing rules and regulations of the FDA.

 

VIII. GROUNDS FOR DISAPPROVAL, CANCELLATION OR SUSPENSION OF LICENSE, REGISTRATION OR AUTHORIZATION

 

The following shall be grounds for disapproval, cancellation or suspension of license, registration or authorization:

 

  1. Non-compliance with the standards and guidelines of the FDA and other concerned agencies such as the NRL-EAMC, Department of Environment and Natural Resources – Environmental Management Bureau (DENR-EMB), etc.;
  2. Material misrepresentations, misbranding, and/or falsifications of approved licenses, registrations or authorizations issued by the CDRRHR;
  3. Violation of any of the terms and conditions of its licenses, registration or authorization;
  4. Change in ownership or management of an establishment; and
  5. Such other analogous grounds or causes as determined by the FDA.

 

  1. INSPECTION / COMPLIANCE MONITORING

 

The FDA shall conduct compliance monitoring of establishments and postmarket surveillance of devices in accordance with the approved guidelines of the FDA on monitoring and post-market surveillance.

 

  1. TRANSITORY PROVISIONS

 

Establishments that manufacture, 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 comply with the provisions of this guideline.

 

  1. SANCTIONS / PENALTY

 

Any person or entity that violates any of the provisions of these guidelines shall be subject to disapproval, cancellation or suspension of authorizations and other applicable fines and penalties as provided for in RA 9711 and Republic Act No. 7394, otherwise known as the “Consumer Act of the Philippines”.

 

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 shall not be affected. 

 

XIII.    REPEALING CLAUSE

 

Provisions from AO 2007-0014 and all other issuances that are 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.

 

Annex A

 

Documentary Requirements for initial application of a License to Operate

 

  1. Duly accomplished application form
  2. Proof of Payment of Fees
  3. Proof of Business Registration

 

  1. 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.

 

  1. Corporation or Partnership

 

  1. Valid Registration with Securities and Exchange Commission (SEC) indicating the same name, address and ownership as the establishment applying for a license.
  2. Articles of Incorporation

 

  1. Cooperative

 

Valid Certificate of Cooperative Development Authority (CDA) indicating the same name, address and ownership as the establishment applying for a license.

 

  1. 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 addition to the documents mentioned above:

 

  1. SEC Certificate containing the phrase “Doing business under the name and style of (Name of Establishment)”. – applicable for Corporations and Partnerships
  2. Valid Mayor’s Business Permit indicating the same name, address and ownership as the establishment applying for a license.

 

  1. Location Map indicating the address, landmarks, type of building for each address mentioned in the application.

 

  1. Supplementary requirements for:

 

  1. Manufacturers

 

  1. Layout of the Manufacturing Plant
  2. Technical Description of the Manufacturing process
  • Proposed product labels and other marketing materials
  1. List of existing clients / buyers
    1. Importer / Distributor

 

  1. Profile of the company where the device was imported
  2. Import permit
  • List of distributors

 

  1. TSD Facility

 

  1. Environmental Compliance Certificate
  2. Hauling/Transport Permit from the DENR
  • Letter of Acceptance from the owner of the sanitary landfill where the waste will be disposed of.
  1. Floor Plan / Installation Plan
  2. Technical Description of the Treatment Process including pollution control measures being implemented in the TSD facility
  3. List of existing clients

 

  1. Healthcare Waste Generators with treatment facility

 

  1. License to Operate / Permit / Authorization issued by the Department of Health
  2. Letter of Acceptance from the owner of the sanitary landfill where the waste will be disposed of.
  • Floor Plan / Installation Plan
  1. Technical Description of the Treatment Process including pollution control measures being implemented in the treatment facility
  2. List of existing clients

 

Documentary Requirements for Renewal of License

 

  1. Duly accomplished application form
  2. Photocopy of previously issued license
  3. Affidavit of Continuous Compliance
  4. Proof of payment

.

Requirements for Amendment of a License

 

A change in ownership or location of manufacturing site or TSD facility shall mean revocation of the previously issued license. The establishment has to apply for a new license and has to comply with the requirements for initial application of an LTO.

 

For change of Business Name or office address, the following requirements should be submitted:

 

  1. Duly accomplished application form;
  2. Letter stating the changes/amendments to be made;
  3. 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.
  4. Proof of payment

 

Annex B

 

Documentary Requirements for initial application of a Certificate of Product Registration

 

  1. Duly accomplished application form
  2. Photocopy of LTO
  3. Technical Report that includes the following data:

 

  1. Characteristics and Sources of generated waste;
  2. Detailed description of the treatment process;
  3. Technical specifications of the device applied for a CPR;
  4. Operating procedures and conditions including treatment time, pressure, temperature, treatment cycle, chemical concentration, doses, feed rates and waste load composition whichever is applicable;
  5. Storage, handling and volume capacity;
  6. Technical description of accessories attached to the device such as shedders, boilers etc.;
  7. Applicable emission controls for suspected emission;
  8. Potential hazards/toxicities of waste residues;
  9. Energy efficiency / electrical requirements;
  10. Occupational safety and health assurance.

 

  1. Operational Manual
  2. Maintenance Manual
  3. Layout / Plans

 

  1. Location of installation;
  2. Design / Drawing or picture of the device applied for CPR.

 

  1. 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 the 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) calendar days from the receipt of the endorsement letter.

 

Documentary Requirements for Renewal of Registration

 

  1. Duly accomplished application form
  2. Photocopy of valid Performance Evaluation Report from the NRL-EAMC
  3. Affidavit of Continuous Compliance
  4. Valid Performance Evaluation Report from the NRL-EAMC
  5. Proof of payment 

Requirements for Amendment of Registration

A change in design / technical specifications 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.

For change of business name or office address, the following requirements should be submitted:

  1. Duly accomplished application form;
  2. Letter stating the changes/amendments to be done;
  3. 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;
  4. Letter stating that the no change was made with regards to the design or technical specifications of the device; and
  5. Proof of payment.

 

Attachments:
Download this file (Draft AO.pdf)Draft AO.pdf

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