The present FDA guidance is dedicated to the regulatory requirements associated with applying for the License to Operate (LTO) required for entities to be allowed to conduct certain activities related to medical devices and other healthcare products. The approach to be applied in this regard is based on the Administrative Order No. 2020-0017 “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative order No.2016-0003”. The aforementioned regulation issued by the FDA amends and improves the existing regulatory framework in terms of the procedures to be performed by means of an online portal operated by the regulating authority. The provisions of the new regulation are also aligned with the general approach towards further facilitation of the regulatory procedures in order to reduce the paperwork burden the interested parties face, including further expansion of the use of the electronic submissions and forms. At the same time, the official online portal operated by the regulating authority has also been updated to include the applications for the wholesalers, importers, and exporters of medical devices.
The document is intended to provide interested parties with additional recommendations and clarifications regarding the use of the FDA eServices Portal System when applying for the License to Operate for certain regulated activities.
The scope of the document covers the following types of entities:
- Traders; and
- Distributors, including wholesalers, importers, exporters.
The procedures covered by the scope of the guidance include the initial applications, as well as the application of renewal and variation.
The FDA emphasizes that the interested party applying for the License to Operate (the applicant) shall achieve and sustain compliance with any and all applicable regulatory requirements. Moreover, the applicant shall be solely responsible for complying with the applicable national and international standards on safety, quality, and effectiveness of medical devices intended to be placed on the market in the Philippines.
The guidance issued by the Philippines FDA further describes the regulatory requirements for each type of application to be submitted via the FDA eServices Portal System, including the documents and information to be provided by the applicant.
According to the document, the initial application should be submitted in electronic form and accompanied by the following documents:
- Declaration of Undertaking;
- Location plan (including the GPS coordinates and name of the responsible person);
- Proof of business name registration (the appropriate certificate of registration issued by the respective authority);
- Proof of income (e.g., the audited financial statements for already operating entities or a statement/certification of initial capitalization for the newly established ones);
- Confirmation of the payment of the applicable fees;
- Business permit (to be submitted in case if the actual address is different from the registered address).
In case of the application for renewal, it would be sufficient to submit the appropriate form accompanied by the Declaration of Undertaking, and the confirmation of payment. For the applications for the variation to existing License for Operations, the interested party shall submit an e-Application Form accompanied by the Declaration of Undertaking, together with the appropriate documentation describing the changes to the applicant entity itself or the medical device in question, and also the confirmation of the fees paid.
The particular documents to be submitted with the application for variation would depend on the nature of changes taking place.
1. In case of changes to the location, proof of a new business address is required.
2. In case of changes to the activities to be conducted by the entity, the appropriate agreement should be submitted.
The guidance also describes the documents to be submitted in such cases as:
- Transfer or addition of a warehouse,
- Change of the ownership of the license holder,
- Change of business name,
- Limited changes to the address,
- Appointment of a new qualified person responsible for regulatory matters,
- Appointment of a new authorized person.
Apart from the regulatory requirements for the various types of applications, the present FDA guidance also describes the qualification and credential requirement for the qualified person. According to the document, in order to meet the eligibility criteria, such a person should be graduated in one of the related spheres, and also provide the appropriate professional certificates.
Application Process in Detail
The draft guidelines developed by the Philippines FDA also describe in detail the procedures to be followed by the interested party applying for the License to Operate. The key aspects to be considered by the applicant include the following:
1. The application, irrespectively of its type, should be submitted online in electronic form via the eServices Portal. It is also important to mention that the applicant is not required to create the appropriate account to be able to file the submission.
2. When submitting the application, the interested party shall provide its explicit consent with the Declaration of Undertaking. In accordance with the aforementioned declaration, the applicant agrees to provide accurate and up-to-date information and be responsible for the medical devices placed on the market, and also comply with any and all applicable rules and regulatory requirements. The authority also emphasizes that the provision of false or misleading information could result in fines and penalties as prescribed by applicable administrative legislation.
3. The electronic form to be filled in by the applicant contains additional reminders notifying the applicant of the importance of ensuring the accuracy of the information provided. Moreover, the information provided in the eApplication should be consistent with the details contained in the additional document accompanying the submission.
4. The contact email address indicated by the applicant cannot be changed. Thus, the interested party submitting the application shall be solely responsible for ensuring the accuracy of the email address since it would be used for all further communications.
5. Once the License to Operate has been approved by the regulating authority, the license holder shall submit a notification of sources.
6. Different types of applications should be submitted separately. Each type of request requires a separate application. Hence, the applications for variation and renewal should not be combined. The application for renewal should be submitted no later than 90 days before the expiration of the License to Operate.
In summary, the present draft guidance issued by the Philippines FDA describes the regulatory requirements for applications to be submitted by the parties interested in conducting distribution activities. In particular, the document provides the details regarding the types of applications and also on the information to be submitted in each case.
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