Basic information
Outline of the system
The Department of Health (DOH) issued Administrative Order (AO) No. 2020-0017 entitled “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing AO No. 2016-0003”. This AO aims to simplify the requirements and processes for initial, renewal and variation of License to Operate (LTO) applications; and to re-engineer and streamline FDA’s processes and automate its system in compliance with the provisions of Republic Act No.11032 on the maximum prescribed processing time depending on the complexity of the transaction.
Product coverage
(a) Medical devices for commercial distribution;
(b) Medical device products for personal use:
• In-Vitro Diagnostic (IVD) Products - 1 piece of each type (except for IVD kits used as maintenance test strips which are sold by packs can be up to 100 pieces)
• Medical Devices - 1 piece of each type (except for medical devices used as maintenance such as insulin needles and lancets which are sold by packs can be up to 100 pieces).
Imports of FDA-DOH regulated products may be brought into the Philippines without prior clearance from the FDA, provided such products are
a. For personal use
b. In quantities not exceeding the limits
c. Brought into the Philippines in any of the following ways:
i. In passenger baggage, whether accompanied or unaccompanied;
ii. In balikbayan boxes; or
iii. In parcels sent through mail or delivery services.
Any quantity of the covered medical device products for personal use, whether declared or undeclared, beyond the specified limits which does not have the required FDA-DOH clearance, will be seized and forfeited in favour of the government. Those within the specified limit shall be allowed without FDA-DOH clearance subject to payment of customs duties, when necessary.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Non-automatic licensing to simplify the requirements and processes for initial, renewal and variation to LTO.
Products under restriction as to the quantity or value of imports
There are no limits set on the quantity or value of imported medical device products which are intended to be placed in local trade, provided that such products are registered with the FDA and that the importer is duly-licensed with the FDA.
Questions for products under restriction as to the quantity or value of imports
Not applicable
The system applies to products originating from which country?
The system applies to goods originating from any country.
Expected duration of licensing procedure
Ongoing
Legal requirements
Is the licensing statutorily required?
The licensing system implemented by the FDA is based on Republic Act No. 9711 otherwise known as the “FDA Act of 2009” and its Implementing Rules and Regulations, where the licensing of establishments and the registration of health products under the jurisdiction of the FDA are statutorily required.
Procedural guidelines for the licensing application system are provided in AO No. 2020-0017.
Other issuances pertaining to LTO application:
FDA Circular No. 2021-014 - Guidelines for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Traders and Distributors including Wholesalers, Importers, and Exporters of Medical Devices, Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste and Water Treatment Devices/Systems;
FDA Circular No.2021-0021 - Guidelines on the Licensing of Retailers of Medical Devices in the Philippines;
FDA Circular No.2022-007 - Guidelines on the Use of the Food and Drug Administration eServices Portal System for License to Operate (LTO) Application of Retailers of Medical Devices; and
Medical device products for personal use as per DOH-FDA – BOC Joint Circular No. 1 entitled “Importation of FDA-DOH Regulated Products for Personal Use”.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
The licensing system applies to manufacturers, traders, distributors (importers, exporters and wholesalers) and retailers of medical device products that are intended to be placed in the Philippine market. All entities allowable to engage in business in the Philippines may apply for a license with the FDA, provided that administrative and technical requirements can be sufficiently satisfied by the applicant.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Food and Drug Administration
Address
1781 Civic Dr, Alabang, Muntinlupa, 1781 Metro Manila
Telephone
+ 632 8 857-1900
Fax
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Food and Drug Administration
Documentation requirements
What information is required in applications?
Procedural guidelines for the licensing application system are provided in AO No. 2020-0017.
Other issuances pertaining to LTO application:
FDA Circular No. 2021-014 - Guidelines for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Traders and Distributors including Wholesalers, Importers, and Exporters of Medical Devices, Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste and Water Treatment Devices/Systems;
FDA Circular No.2021-0021 - Guidelines on the Licensing of Retailers of Medical Devices in the Philippines; and
FDA Circular No.2022-007 - Guidelines on the Use of the Food and Drug Administration eServices Portal System for License to Operate (LTO) Application of Retailers of Medical Devices.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
An establishment intending to engage in the importation of medical devices must consider the processing timelines provided in the agency Citizen’s Charter in securing the necessary authorizations.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Applications for LTO are received during usual business operating hours.
Issuing the license
Can a licence be granted immediately on request?
As a general rule, applications are processed following the timelines provided in the FDA Citizen’s Charter.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The processing timelines for an importer license are as follows:
Initial LTO as medical device importer: 8 Working Days (WD) for LTO evaluation – 14 WD total Renewal LTO as medical device importer: 3 WD for LTO evaluation – 14 WD total
Which administrative body is responsible for approving application of licences?
The processing and approval of LTO issued by the FDA for the medical device establishments under its jurisdiction are conducted solely by the FDA. Applications for LTO of manufacturers, traders, distributors (importers, exporters and wholesalers) and retailers of medical devices are processed by FDA – Center for Device Regulation, Radiation Health and Research (CDRRHR).
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
Continuous compliance to existing rules, regulations, and standards is monitored by the FDA through post-marketing surveillance activities. Failure to demonstrate continuous compliance as a condition of its authorization may be a ground for the disapproval of an application and suspension or cancellation of an authorization.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Fees and charges are provided under DOH Administrative Order No. 50 s. 2001.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
Not applicable.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
Any of the following or similar instances shall be a ground for disapproval:
a. The documentary requirements submitted show that the establishment does not meet the required technical requirements and/or appropriate standards;
b. The applicant made misinterpretations, false entries, or withheld any relevant data contrary to the provisions of the law or appropriate standards;
c. The owner has violated any of the terms and conditions of its license; and
d. Such other analogous grounds or causes as determined by the FDA.
Are the reasons for any refusal given to applicants?
Have applicants a right of appeal in the event of refusal to issue a licence?
If so, to what bodies and under what procedures?
Importation
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
A valid LTO and a Certificate of Product Registration/Notification are required.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Regulations of the Bureau of Customs and the Bureau of Quarantine are separately promulgated by the said agencies.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The initial LTO (Importer) has a validity of one (1) year, and a two (2) years validity after the renewal.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
Not applicable
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
A Market Authorization Holder shall apply for a LTO variation in case that there are changes to the particulars of a license. Allowable variations and the necessary requirements are provided in DOH Administrative Order No. 2020-0017.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Regulations of the Department of Finance, Bureau of Internal Revenue, Bureau of Customs, and Bangko Sentral ng Pilipinas are separately promulgated by the said agencies.