Professional Documents
Culture Documents
Art. II, Sec. 15 - The State shall protect and [Art. 4 (q)] - "Consumer products and services"
promote the right to health of the people and means goods, services and credits,
instill health consciousness among them.
debts or obligations which are primarily for
personal, family, household or agricultural
Art. XVI, Sec. 9 - The State shall protect purposes, which shall include but not limited to,
consumers from trade malpractices and from food, drugs, cosmetics, and devices.
the body of humans or animals; or (4)articles (1) Any substance or mixture of substances
intended for use as a component of any articles intended for individual or limited purposes and
speci ed in clauses (1), (2), or (3) but do not which is toxic, corrosive, an irritant, a strong
include devices or their components, parts or sensitizer, is ammable or combustible, or
accessories.
generates pressure through decomposition,
heat or other means, if such substance or
(g) 'Device' means medical devices, radiation mixture of substances may cause substantial
devices and health-related devices.
injury or substantial illness during or as a
(1) 'Medical device' means any instrument, proximate result of any customary or
apparatus, implement, machine, appliance, reasonably foreseeable ingestion by children,
implant, in-vitro reagent or calibrator, but shall not include agricultural fertilizer,
software, material, or other similar or related pesticide, and insecticide, and other
article intended by the manufacturer to be economic poisons, radioactive substance, or
used alone, or in combination, for human substances intended for use as fuels,
beings for one or more of the speci c coolants, refrigerants and the like;
purpose(s) of: diagnosis, prevention,, (2) Any substance which the FDA nds to be
monitoring, treatment or alleviation of disease; under the categories enumerated in clause (1)
diagnosis, monitoring, treatment, alleviation of this paragraph;
of, or compensation for an injury; (3) Any toy or other articles intended for use by
investigation, replacement, modi cation, or children which the FDA may determine to
support of the anatomy or of a physiological pose an electrical, chemical, physical, or
process; supporting or sustaining life; thermal hazard; and
preventing infection; control of conception; (4) This term shall not apply to food, drugs,
disinfection of medical devices; and providing cosmetics, devices, or to substances intended
information for medical or diagnostic for use as fuels when stored in containers and
purposes by means of in-vitro examination of used in the heating, cooking or refrigeration
specimens derived from the human body. This system of a house, but such term shall apply
device does not achieve its primary intended to any article which is not in itself an
action in or on the human body by agricultural pesticide but which is a hazardous
pharmacological, immunological, or metabolic substance, as construed in paragraph (1) of
means but which may be assisted in its this section, by reason of bearing or
intended function by such means.
containing such harmful substances
(2) 'Radiation device' means an electrical or described therein.
intended as plaything for children as de ned in (3) any article other than food intended to a ect
these Rules, subject to the exclusions as the structure or any function of the human
provided herein.
body or animals;
[Sec. 3 (a)] Telecommunications - any process (5) herbal and/or traditional drugs which are
which enables a telecommunications entity to articles of plant or animal origin used in folk
relay and receive voice, data, electronic medicine. x x x
(b) Drugs and medicines indicated for prevention 861 SCRA 515 (2018)
of diseases, e.g., vaccines, immunoglobulin,
anti-sera;
Persons or Entities
(c) Drugs and medicines indicated for prevention
of pregnancy, e.g., oral contraceptives;
Consumer
(d) Anesthetic agents;
Includes: Heated Tobacco Products (HTPs); [Art. 4 (as), RA 7394] - Manufacturer means any
Electronic Nicotine/Non-Nicotine Delivery person who manufactures, assembles or
Systems (ENDS/ENNDS) and Other Novel processes consumer products, except that if the
Tobacco Products.
goods are manufactured, assembled or
processed for another person who attaches his
• RA 9211 (Tobacco Regulation Act of 2003)
own brand name to the consumer products, the
• I n t e r- A g e n c y C o m m i t t e e - To b a c c o latter shall be deemed the manufacturer. In case
Memorandum Circular No. 1, Series of 2004, of imported products, the manufacturer's
IRR of RA 9211
representatives or, in his absence, the importer,
• I n t e r- A g e n c y C o m m i t t e e - To b a c c o shall be deemed the manufacturer.
the seller.
f) Layout-Designs (Topographies) of Integrated
Circuits; and
or Seller.
Agent/Contractor/Service provider
Advertiser
Third Parties
CASE: