A contact lens is a medical device.

Contact lenses and glasses with refracted lenses may be

similar, but are not interchangeable.

The current medical device regulations in the Philippines require companies to obtain a
Certificate of Product Registration (CPR) for products mentioned in the list of medical devices1
or a Certificate of Exemption (COE) prior to a device being imported and placed on the market
as well as a License to Operate (LTO)

Checklist of Requirements for Certificate of Exemption (COE) Product Registration2

1. Letter of Intent regarding exemption of the device/product from registration

2. Photocopy of Product Brochure/Description of the Product
3. License to Operate as Medical Device Distributor/Importer/Exporter
4. Fee and Payment assessment slip3 (computation of fee is per product as indicated in the
letter of intent)

Obtaining a License to Operate (LTO)

In pursuant to FDA Circular No. 2014-003: Filing and Receiving of Registration, Licensing, and
other Applications using the Application Form the following are the steps of the LTO Processing:

For Initial Application

1. Accomplished Application Form with Declaration and Undertaking

a. Declaration and undertaking of the responsibilities of the applicant as a condition
for the processing and approval of the LTO
b. The location plan and global position system (GPS) coordinates of the
establishment
c. The name of the qualified person per type of establishment, and the relevant
credentials (e.g. PRC ID)
2. Proof of Business Name Registration
a. It must be supported by the copy of the Certificate of Registration issued by SEC
and Articles of Incorporation.
b. The document must indicate the exact and complete address.
c. In case the business address of the applicant is different from the one indicated in
its business name registration, the applicant must submit a copy of its valid
Business Permit.
3. Site Master File (for manufacturers of drugs, devices and cosmetics)
4. Risk Management Plan

1FDA Memorandum Circular No. 2014-005 https://www.asiaactual.com/wp-

content/uploads/2017/12/FMC2014-005-Updated-List-of-Medical-Devices-required-to-be-
Registered-Prior-to-Sale-Distribution-and-Use.pdf
2

https://ww2.fda.gov.ph/attachments/article/95819/Checklist%20Requirements%20COE%2020
18.pdf
3 https://www.formsphilippines.com/downloads/FDA/MDF/05.pdf
 a. Contain details on how to identify, characterize, prevent, or minimize risk relating
to the products that the establishment is engaged with
b. Includes post-marketing surveillance activities and interventions to manage the
risk
5. Within 2 working days, a Document Tracking Log (DTL) is sent with a schedule for
submission
6. Payment of the appropriate filing fee
a. Fees are paid either at Land Bank branches or at the main FDA cashier

For Renewal Application

 Accomplished Application Form with Declaration and Undertaking

 Payment of the appropriate filing fee