MEDICAL DEVICE
REGISTRATION
Dr. Jose Jacinto D. Cordero
Regulatry Affairs Specialist

GOVERNING LAW
FDA CIRCULAR 2020-001
INITIAL IMPLEMENTATION OF
ADMINISTRATIVE ORDER 2018-
0002
FDA CIRCULAR 2020-001A
FINAL IMPLEMENTATON OF
ADMINISTRATIVE ORDER
2018-002
2

RISK CLASSIFICATION
3
ADMINISTRATIVE ORDER 2018-2002
GUIDELINES GOVERNING ISSUANCE OF AN AUTHORIZATION
FOR A MEDICAL DEVICE BASED ON THE ASEAN HARMONIZED
TECHNICAL REQUIREMENTS

MEDICAL DEVICE CLASSIFICATION
4
MODERATE – HIGH
e-submission
HIGH
e-submission
LOW
e-portal
LOW-MODERATE
e-submission

PART I
LEGAL REQUIREMENTS
5
MEDICAL DEVICE REGISTRATION
REQUIREMENTS
(CLASS A)

I. NOTARIZED AGREEMENT
▰ Product being applied must be indicated.
▰ Name of Applicant
▰ Should be accompanied by notarized
declaration from the supplier/principal that
the agreement is true/authentic and correct.
6

II. QMS CERTIFICATE OR ISO 13485
▰ Must be valid.
▰ Product being applied must be indicated in the
scope.
▰ Should be accompanied by notarized declaration
from the supplier/principal that the certificate is
true/authentic and correct.
7

III. PRODUCT REGISTRATION EQUIVALENT
▰ Must be valid.
▰ Certificate of Medical Device Notification.
▰ Certificate of Product Registration.
▰ Should be accompanied by notarized
declaration from the supplier/principal that
the certificate is true/authentic and correct.
8

“FREE SALE CERTIFICATE (FSC)
is not accepted as product
registration equivalent.
9
9

IV. PRODUCT PHOTO
▰ Clear, colored picture of the commercial
product sample from all sides without the
packaging.
10

PART II
TECHNICAL REQUIREMENTS
11
MEDICAL DEVICE REGISTRATION
REQUIREMENTS
(CLASS A)

I. INTENDED USE
▰ Must indicate the specific use of product
being appplied.
▰ If product is part of the system, the specific
use of the product as part of the system
should be indicated and not the intended use
of the system
12

II. INSTRUCTION FOR USE
▰ Detailed instruction for use for the users of
the medical device.
▰ The instruction should be clear enough to
guide the users.
13

III. LIST OF RAW MATERIALS
▰ This should include all the raw materials as
component of the medical device itself.
14

IV. TECHNICAL SPECIFICATIN OF FINISHED
PRODUCT
▰ This should include the technical specification
of the finished products (physical, chemical,
mechanical, electrical, etc.). This maybe in the
form of Certificate of Analysis or Test
certificate.
15

V. CERTIFICATE OF CONFORMITY
▰ (Issued by government agency dealing with metrology)
on the aspect of manufacture relating to metrology for
devices with measuring functions, if applicable i.e.
Weighing Scale, etc.
▰ If not applicable, a notarized declaration should be
submitted that the product being applied for has no
measuring function
▰ Must be accompanied by a notarized declaration that
the certification/ self declaration is true and correct.
16

VI. DECLARATION OF CONFORMITY
(MANUFACTURERS SELF DECLRATION)
▰ These are the standards used during the design,
development, manufacture, testing of the medical
devices.
▰ The standards to be considered are Philippine National
Standards (PNS), international standards (ISO, IEC) and
other equivalent national standards (of these
international standards
▰ Must be accompanied by a notarized declaration that
the certification/ self declaration is true and correct.
17

VII. ARTWORK AND LABELING MATERIALS
▰ Clear colored pictures of labels from all sides.
▰ Immediate label, secondary packaging, box label and
package insert/brochure, whichever is applicable.
▰ For any additional product claims on the label, submit
studies or tests supporting the claims.
▰ For imported products, if the brand name is the
product’s local brand, declaration from the
manufacturer allowing use of the brand name and IPO
approval of the said brand name.
18

VII. SHELF-LIFE
▰ For product with shelf-life, submit stability studies to
support the claim.
▰ For product without shelf-life, submit a notarized
declaration/ certification that the product has no shelf-
life and therefor not covered by the requirement. This
must be accompanied by notarized declaration that the
declaration/ certification is true and correct.
19

“
ADDITIONAL NOTES
20
20

21
▰ If a CE marking is reflected on the label, submit valid
certificate supporting the placement of the CE mark.
▰ Pictures and text of the label should be clear and will
not be pixelated when the view is increase in size.
▰ Lot No., Batch No., Serial No., whichever is applicable
should be reflected
▰ Storage condition, sterilization method should be
reflected if applicable.
▰ Importer and distributor’s name and address should be
reflected in the label of the product together with the
Registration No.

22
THANKS!
Any questions?
You can reach me at
09175928646
josejacintodesdircordero@gmail