Repubite of the Phrlippines
HOUSE OF REPRESENTATIVES
Queson City

EIGHTEENTH CONGRESS
‘Second Regular Session

HOUSE BILL NO8029

Introduced by HON. LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR.

AN ACT EXPANDING THE DEFINITION OF "MEDICAL DEVICE" TO INCLUDE
HEALTH APPLICATIONS, FURTHER AMENDING REPUBLIC ACT NO. 3720,
OTHERWISE KNOWN AS THE “FOOD, DRUG, AND COSMETIC ACT,"
AS AMENDED BY REPUBLIC ACT NO. 9711, OTHERWISE KNOWN AS THE
“FOOD AND DRUG ADMINISTRATION (FDA) ACT OF 2009" AND
FOR OTHER PURPOSES

The definition of medical devices under Republic Act (RA) No. 3720, as amended
by R.A. No. 9711, remains outdated and archaic in contrast to the rapid advances of
technology in the medical field. The law does not sufficiently contemplate
applications and digital platforms which have become an integral part of medical
products.

Mobile health applications are receiving increased attention largely due to the global
penetration of mobile technologies. Changes in mobile health and current healthcare
delivery have been emerging that we need to study them in the context of regulation
and its implications for the future

The chalienges in regulating developments in delivering health care includes
balancing the demand to protect consumers from the risks of mobile health
applications while at the same time taking advantage of technologies to improve
healthcare delivery. quality and safety

This bill seeks to further amend R.A. No. 3720 in order io redefine the term "medical
device" to emphasize the inclusion of software and health applications under such
definition and clarify the jurisdiction of the Food and Drug Administration (FDA) over
such medical devices

In view of the foregoing, the immediate passage of this bil! is most earnestly sou

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Luis Sigs peal F. VILLAFUERTE, JR

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RESENTATIVES
Queion Cu

EIGHTEENTH CONGRESS
Second Regular Session

8029
HOUSE BILL NO.

——————————

Introduced by HON. LUIS RAYMUND “LRAY” F_ VILLAFUERTE, JR.

-__eeee———

AN ACT EXPANDING THE DEFINITION OF “MEDICAL DEVICE” TO INCLUDE
HEALTH APPLICATIONS, FURTHER AMENDING REPUBLIC ACT NO. 3720,
OTHERWISE KNOWN AS THE "FOOD, DRUG, AND COSMETIC ACT,"
AS AMENDED BY REPUBLIC ACT NO. 9711, OTHERWISE KNOWN AS THE
“FOOD AND DRUG ADMINISTRATION (FDA) ACT OF 2009" AND
FOR OTHER PURPOSES.

Be it enacted by the Senate and House of Representatives of the Philippines in
Congress assembled:

Section 1. Section 10 (g) (1) of RA No. 3720, as amended, is hereby amended to
read as follows

"SEC. 10. For the purposes of this Act, the term
"XXX

(g) ‘Device’ means medical devices. radiation devices and health-related
devices

“(1) ‘Medical device’ means any instrument, apparatus. implement, machine
appliance. implant, in-vitro reagent or calibrator. software OR HEALTH
APPLICATION. material, or other simiiar or reiated articie intended by the
manufacturer to be used alone. or in combination. for human beings for one or
More of the specific purpose(s) of: diagnosis, prevention, monitoring, treatment
or alleviation of disease: diagnosis, monitoring. treatment. alleviation of, or
compensation for an injury. investigation, replacement, modification, or support
of the anatomy or of a physiological process. supporting or sustaining life.
Preventing infection: control of conception: disinfection of medical devices: and
Providing information for medical or diagnostic purposes by means of in-vitro
examination of specimens derived from the human body. This device 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 intended function by such means.



"XXX'

Section 2. Section 10 of RA No. 3720, as amended. is hereby further amended to
insert a new subsection (nn) to read as follows:

“SEC. 10. For the purposes of this Act. the term
"XXX

“(NN) ‘SOFTWARE OR HEALTH APPLICATION, AS USED IN THIS ACT,
MEANS A MEDICAL DEVICE THAT CAN BE INSTALLED AND/OR
OPERATED ON MOBILE PHONES, TABLETS, COMPUTERS, OR ANY
OTHER COMMERCIAL OFF-THE-SHELF COMPUTING PLATFORM, WITH
OR WITHOUT WIRELESS CONNECTIVITY. ITS FUNCTIONS SHALL
INCLUDE, BUT ARE NOT LIMITED, TO ANY OF THE FOLLOWING:

a, CALCULATE MEDICINE DOSES FOR THE USER:

b. DIAGNOSE A MEDICAL CONDITION OR DISEASE;

c. GIVE THE USER AN INDIVIDUAL PERCENTAGE RISK SCORE OF
HAVING A MEDICAL CONDITION OR DISEASE;

d. PRESCRIBE CURE, MITIGATION, TREATMENT, OR PREVENTION OF
DISEASE; OR

e. DETERMINE CONTACT BETWEEN AN INFECTED PERSON AND A
USER.”

Section 3. Separability Clause. If any provision of this Act is declared
unconstitutional or Invalid, other sections or parts thereof not affected thereby shall
remain in full force and effect

Section 4. Repealing Ciause. All laws, decrees. executive orders. rules, and
regulations, or parts thereof. inconsistent with the provisions of this Act are hereoy
repealed or modified accordingly

Section 5. Effectivity Clause This Act shall take effect fifteen (15) days after its
complete publication in the Official Gazette or In at least one (1) newspaper of
general circulation

Approved.