Medical devices
- Document symbol
- G/LIC/N/3/PHL/15/Rev.1
- Original language
- English
- Published on
- 21/02/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another 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.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
(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.
Q3. The system applies to goods originating in and coming from which countries?
The system applies to goods originating from any country.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
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.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
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”.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
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.
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.
Q7.b. 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.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
Applications for LTO are received during usual business operating hours.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
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).
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
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.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
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.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
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.
Q11. What documents are required upon actual importation?
A valid LTO and a Certificate of Product Registration/Notification are required.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
Fees and charges are provided under DOH Administrative Order No. 50 s. 2001.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The initial LTO (Importer) has a validity of one (1) year, and a two (2) years validity after the renewal.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
Q16. 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.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
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.
Other Procedural Requirements
Q18. 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.
Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?
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.