PITAHC Guidelines on the National Certification of Traditional and Complementary Health Care Devices

2013

PITAHC CIRCULAR NO. 01, S, 2013

GUIDELINES IMPLEMENTING R.A. 8423 IRR ON THE NATIONAL CERTIFICATION OF TRADITIONAL AND COMPLEMENTARY HEALTH CARE DEVICES

RULE I

Policy and Application

SECTION 1. Title. —

These guidelines shall be known as the PITAHC Guidelines on the National Certification of Traditional and Complementary Health Care Devices.

SECTION 2. Purpose. —

These Guidelines are promulgated to prescribe the procedures and guidelines for the implementation of PITAHC IRR on the National Certification and Accreditation of Traditional and Complementary Health Care Devices, pursuant to Rule 1, Section 3, Objectives of IRR of RA 8423. These Rules will likewise support the certification and accreditation of Traditional and Alternative Health Care (TAHC) modalities to pursue continuous service improvement, and strengthen the accountability of all stakeholders in the traditional and alternative health care practices.

SECTION 3. Declaration of Policy. —

It is the policy of the State to improve the quality and delivery of health care services to the Filipino people through the development of traditional and alternative health care and its integration into the national health care delivery system.

SECTION 4. Scope of Application. —

These guidelines shall apply to certification of therapeutic health devices, both local and international, used in traditional and complementary, alternative therapy regimes and techniques. DCScaT

SECTION 5. Definition of Terms. —

For the purpose of these guidelines, the following terms and words and phrases shall mean or be understood as follows:

a. Republic Act 8423 — An Act creating the "Philippine Institute of Traditional and Alternative Health Care (PITAHC)" to accelerate the development of traditional and alternative health care in the Philippines or otherwise known as "Traditional and Alternative Medicine Act (TAMA) of 1997".

b. Traditional and Alternative Health Care (TAHC) — the sum total of knowledge, skills and practices, other than those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical or mental disorders.

c. Traditional Medicine (RA 8423) — the sum total of knowledge, skills and practice on health care, not necessarily explicable in the context of modern, scientific philosophical framework, but recognized by the people to help maintain and improve their health towards the wholeness of their being, the community and society, and their interrelations based on culture, history, heritage, and consciousness.

d. Alternative Health Care Modalities — refer to other forms of non-allopathic, occasionally non-indigenous or imported healing methods, though not necessarily practiced for centuries nor handed down from one generation to another; includes, naturopathy, homeopathy, homotoxicology, reflexology, acupuncture, massage, acupressure, chiropractic, nutritional therapy, yoga, tai chi, qi gong, prayer, reiki, pranic healing, mindfulness meditation, biofeedback, hypnosis, dance and other movement therapies, art and music therapy and other similar methods. DAHCaI

e. Biomedicine — that discipline of medical care advocating therapy with remedies that produce effects differing from those of the diseases treated. It is also called "allophatic medicine", "western medicine", "regular or mainstream medicine", "orthodox medicine" or "cosmopolitan medicine".

f. Alternative/Complementary Medicine — the field of health care outside the scope and coverage of biomedicine.

g. Therapeutic Health Device — any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended by the person under whose name it is to be supplied, to be used for human beings for the purposes of one or more of the following: assessment, prevention, monitoring, therapeutic intervention or alleviation of disease; assessment, monitoring, therapeutic intervention, alleviation of or compensation for an injury or handicap; supporting or sustaining life; providing information for health purposes by means of in vitro examination of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; or an accessory to such an instrument, apparatus, appliance, material or other article.

h. National Certification — process of issuing certificates that requires the needed documentation and other pertinent papers being administered by PITAHC.

i. National Registration — process of issuing certificates of registration requiring the needed documentation and other pertinent papers administered by PITAHC Certification Committee.

j. Portfolio Assessment — evaluation of documents submitted such as technical documentation, Department of Health or any government agency clearance issued from the country of origin as evidences of safety for review by PITAHC Certification Committee.

k. Government Certificate of Clearance and Free sale — a document from government agency required in certain countries or for certain commodities, certifying that specified imported goods are normally and freely sold in exporting country's open markets and are approved for export. SEcAIC

 Delimitation:

 The Guidelines does not cover PITAHC's responsibility on any adverse effect and improper use of the device by the end user.

RULE II

Certification of Therapeutic Health Devices

SECTION 1. All therapeutic health devices are required to be registered and obtain the necessary Certification based on PITAHC Standards for Traditional and Complementary Health Care Devices (TCHCD), in line with the policy of ensuring its quality, safety and efficacy. The certification program applies to mandatory compliance with minimum standards and requirements of all traditional and complementary health care devices being used by TAHC practitioners.

SECTION 2. The application for certification of therapeutic health devices will be filed at the PITAHC Standard and Accreditation Division where the evaluation process and the National Certification Assessment shall be conducted.

SECTION 3. The PITAHC shall do monitoring of the continuous compliance on the therapeutic health devices being used by TAHC practitioners within the minimum requirements of PITAHC prescribed standard.

RULE III

Criteria for Certification of Therapeutic Health Devices

SECTION 1. Requirements for Certification of Therapeutic Health Devices. —

The following requirements for the certification of therapeutic health devices shall be submitted to PITAHC. EcATDH

a. Notarized Letter of Application from manufacturer/trader/distributor of the therapeutic health device.

b. Valid License to Operate (LTO) of manufacturer/trader/importer/distributor or wholesaler. In lieu of LTO for Inventive Therapeutic Health Devices, there is a need for a Patent Approval from the Intellectual Property Office (IPO) in equivalence of exclusivity to make, use and vend such invention throughout the Philippines.

 For imported therapeutic health devices with Patent Approval from Country of origin, the International Law for Patent shall be applied, meeting such established applicable safety and quality standards.

c. Government Certificate of Clearance and Free sale/registration approval of the health device from country of origin and duly authenticated by territorial Philippine Consulate for imported product.

d. Government Certificate attesting to the status of the manufacturer, competency and reliability of the personnel and facilities and duly authenticated by territorial Philippine Consulate and/or ISO Certification for imported health device.

e. Certificate of agreement between the manufacturer and trader/distributor/importer regarding the health device.

f. Technical specifications and physical description of the health device including specific use and direction for use with corresponding contraindication, if any.

g. Copy of latest Certificate of Product Registration (CPR). In absence of the CPR, an approved patent both from country of origin and the Philippines would suffice. Another exemption is, if the device has been awarded by the UN World Intellectual Property Organization. HAIaEc

h. List of amount and technical specifications of materials used.

i. Brief description of the methods used, the facilities and control in the manufacture, processing and packaging of the health device. For sterile products, specify sterilization procedure, manufacturing and expiration date. Scientific Stability studies of the health device to justify claimed expiration date, if applicable.

j. For electrical therapeutic health devices, there is a need for Bio-compatibility studies and Risk Analysis. If there are no bio-compatibility studies and risk analysis, this will be referred to the Center for Device Regulation, Radiation Health and Research of FDA-DOH.

k. For devices that require special skills (i.e., that would involve invasive procedure) there has to be an accompanying training package on the operation and use of the device.

l. Labeling materials to be used for the health device: immediate label, box label and packaging insert/brochures, if available.

m. Representative sample in market or commercial presentation.

n. A duly accomplished application form for Certificate of Registration.

o. Application/Filing fee will be collected based on the national accounting rules and regulations.

o.1 An application/filing fee of one thousand pesos (P1,000.00) shall be paid to PITAHC upon submission of the application form and required attachments/documents

p. Other pertinent documents as may be required from time to time by PITAHC based on Committee recommendation.

p.1 Food and Drug Administration Certification clearance or Certification from any government agency responsible from country of origin DHTECc

p.2 Certification from institutions, hospitals, clinics, hubs, spas etc. that use the health device, if any. 

p.3 PITAHC-DOH joint clearance as reviewed by the National Certification Committee, including clearance from the Technical and Safety expert of the committee including attachment of seals of PITAHC and DOH on the package of the health device.

The Committee may likewise require a detailed description of the health device as follows:

A. Description of the Health Device

a. Name of the Health Device

b. Name and place of origin and manufacturing of the health device

c. Historical background of the health device

d. What and how the health device is used

d.1 The health conditions the device is used or applicable for

d.2 Procedure for the use of the health device

e. Protocols necessary before, during and after the use of the health device

f. Limitations on the use of health device

B. Studies and Evidence supporting the device

a. Historical Background in brief

b. Science behind the diagnostic device in brief TcCSIa

b.1 Quantitative or Qualitative research (should indicate the name of the institution and individual as well as the license name and number and the mandate of the institution, as applicable who already had undertaken such a study or had given endorsement to the product for use based on first hand clinical or practical experiences or first hand experiences of patients that have been authenticated by their consultant)

b.2 Quantitative (Xerox copy of the original and PDF soft copy)

• Number of Population served

• Race of Population served

• State of well-being of the population served (sick or well)

• Methodology of the study in brief

• Results of the study in tables and figures with Descriptions

b.3 Qualitative (Xerox copy of the original and PDF soft copy)

• Number of Population served

• Race of Population served

• State of well-being of the population served (sick or well)

• Methodology of the study in brief

• Salient features of the study in bullets based on expert observation (consultant or practitioner based) and or expert authenticated observation of patients involved (patient based) DaESIC

b.4 Details of Publication of Studies as applicable

• Proof of publication

• Name of Publisher

• Place Published

• Date Published

SECTION 2. Issuance of Certificate of Registration. —

Upon review and approval of the submitted documents or if the applicant has satisfactorily complied with the minimum prescribed requirements, PITAHC shall issue the Certificate of Registration with a PITAHC dry seal in favor of the applicant.

SECTION 3. Grounds for Cancellation of Certification. —

Any of the following acts or omissions shall be sufficient ground for the cancellation of certificate of registration:

a. Falsification of documents

b. Failure to maintain the standards and requirements for certification as prescribed in these Guidelines

c. Making misrepresentations or false declarations about the health device

SECTION 4. Validity of Certificate of Registration. —

A Certificate of Registration granted under these guidelines shall be valid for three (3) years from date of issue. Date of renewal shall be three (3) years thereafter subject to suspension or cancellation for cause to be determined by PITAHC. aHSAIT

SECTION 5. Non-Transferability of Certificate of Registration. —

The Certificate of Registration issued for a specific health device shall be non-transferable.

SECTION 6. Certification Fee. —

The certification fee shall be collected from those applicants who have successfully complied with the requirements. A certification fee of Three Thousand Pesos (P3,000.00) will be collected based on the national accounting rules and regulations and may be changed anytime upon review of PITAHC Committee.

SECTION 7. Renewal of Certification. —

The Certification shall be renewed on or before its date of expiration. A renewal certification fee of Two Thousand Pesos (P2,000.00) shall be collected from renewing certified applicants. A penalty of five hundred pesos (P500.00) shall be charged per year for non-renewal of certification. The penalty fee may be changed anytime upon review of PITAHC Committee.

RULE IV

The National Certification of Traditional and Complementary Health Care Devices

SECTION 1. The National Certification Committee for Traditional and Complementary Health Care Devices. —

For the purpose of certifying Traditional and Complementary Health Care Devices, the PITAHC Director General shall invite active practitioners in the field of Traditional and Complementary Health Care, hereinafter referred to as National Certification Committee for Traditional and Complementary Health Care Device. The invitation is valid only for the period indicated herein, and may be renewed by the Director-General. CcTHaD

a. Composition

 The Committee shall be composed of the following:

 PITAHC Director General — Ex-officio Chairperson

 Permanent Representatives:

 PITAHC Advocacy and Training Division Chief

 PITAHC Standard and Accreditation Division Chief

 Representatives of the following sectors:

 Two (2) Medical Traditional and Complementary Health Care (TCHC) practitioners

 One (1) Traditional and Complementary Health Care (TCHC) practitioner

 One (1) A scientist knowledgeable of TCHC practices and devices

 One (1) Representative from a Consumer's Group/Health-Related NGO who is a TCHC practitioner

 The PITAHC Director General, upon recommendation of a Committee for selection of the Sectoral Representatives, shall appoint the five (5) Sectoral representatives. Of the initial appointive members, three (3) shall have a term of two (2) years and the remaining two (2) shall have a term of one (1) year. Succeeding sectoral representatives shall serve a term of two (2) years. Any vacancy can be filled provided they serve the expired term of the vacancy.

b. Quorum and Vote

 Actions taken by the National Certification Committee for Traditional and Complementary Health Care Device should be by a majority vote of the five (5) representatives from the identified sectors above, in a meeting duly called for the purposes, attended by a majority of members (3 of 5 representatives), and are subject to PITAHC approval. The PITAHC Director General shall cast his vote in the event of a tie among the sectoral representatives-members in a meeting duly called for said purposes, there being a quorum. DSETac

c. The Standard and Accreditation Division shall serve as committee secretariat.

SECTION 2. Duties and Functions of the Committee. —

a. Develop and maintain the assessments based on the prescribed standards and guidelines

b. Administer the national certification assessment for traditional and complementary health care device

c. Issuance of Certificate of Registration

d. Revoke certification as stated in Section 3, Rule III, Grounds for Cancellation

e. Develop and monitor databank of certified traditional and complementary health care devices

SECTION 3. Place of Assessment. —

The assessment for Certification shall be conducted at PITAHC or other venues as may be determined by PITAHC Committee.

SECTION 4. Result of Assessment. —

Results of the assessment shall be published at the bulletin board or publication of PITAHC. For those deferred applicants that have to submit other documents, as required and requested by the Committee, PITAHC will officially inform them through a letter.

SECTION 5. Provisional Certification. —

PITAHC shall waive the requirements and grant a certificate to a resident Filipino applicant, whose health device has an approved Philippine patent or has been awarded or certified by any Internationally recognized Certifying Organization such as UN World Intellectual Property Organization, residing in the Philippines at the time of passage of the Guidelines, who presents evidence satisfactory to the PITAHC National Certification Committee not later than 3 years upon effectivity of the Guidelines on the National Certification of Traditional and Complementary Health Care Device. acEHCD

SECTION 6. Effectivity. —

These Guidelines shall take effect fifteen (15) days after its publication in the Official Gazette or in at least two (2) newspapers of general circulation. All issuances inconsistent with the provisions of this PITAHC Circular are hereby suspended or amended accordingly.

 

(SGD.) JUVENCIO F. ORDOÑA, MDDirector-General Philippine Institute of Traditional and Alternative Health Care