The article provides a brief overview of the applicable regulatory requirements set forth under the existing legal framework.
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The Food and Drug Administration (FDA) of Taiwan, the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to electronic submissions for medical devices. The document provides an overview of the relevant regulatory procedures, as well as additional clarifications and recommendations to be taken into consideration by the parties responsible for medical devices in order to ensure compliance with the existing legal framework.
At the same time, the authority reserves the right to make changes to the guidance and recommendations provided therein, should it be reasonably necessary to reflect the corresponding amendments to the underlying legislation. In accordance with the applicable regulations, the electronic submission system for second and third-class medical device registration, license modification, and extension offers a streamlined process for medical device businesses (referred to as “applicants”).
This system, managed by the Medical Device and Cosmetic Division, simplifies administrative tasks, ensuring compliance with regulations. While the system excludes first-class medical devices, applications involving both second/third-class and first-class products can be processed together.
Applicants are further encouraged to familiarize themselves with the detailed application process.
Submission of Application Forms
According to the guidance, all registration application forms, review forms, license modification requests, and license extension requests must be completed using the system-generated templates. These forms must be stamped with the company’s official seals (both large and small) before uploading a color-scanned version to the system.
This process ensures the integrity and authenticity of submissions. For applications requiring second or third-class medical device registration, license modification, or license extension, paper originals must be submitted to the FDA.
However, it is important to mention that if documents are electronically signed and comply with electronic signature regulations, paper originals are not necessary. This step ensures that critical legal and regulatory documentation is appropriately verified.
File Format and Size Requirements
As explained by the authority, applicants must adhere to the following file submission guidelines:
- Upload files in searchable PDF format to facilitate review.
- For scanned documents, ensure they are color PDFs.
- Each file must not exceed 50 MB; larger files must be divided into smaller parts.
- Chinese instruction manuals must be submitted in an editable Word format.
The above requirements have been introduced and should be followed by the applicants to ensure that the submission is accessible and reviewable by the FDA.
Application Methods
Currently, the system offers two submission methods to accommodate varying applicant needs:
- Web Version: all application documents should be uploaded directly to the system. Applicants are encouraged to download a compressed backup of their submission for future reference. Additionally, applicants should submit paper originals to the FDA within three business days of the online submission.
- Offline Version: applicants should download the offline disc folder format from the system, place the necessary documents into the designated folder format, and then burn the folder onto a disc and mail it, along with the paper originals, to the FDA within three business days of the online submission.
Thus, the above options provide flexibility, allowing applicants to choose the method that best fits their operational capabilities.
Submission Cover Page
It is also important to mention that applicants must download and include the submission cover page from the system. The cover page serves as the first page of the submission and ensures proper identification of the application.
The document additionally emphasizes that submissions missing the cover page will not be processed by the FDA.
Follow-Up Actions
All follow-up tasks, including submitting supplementary materials, filing appeals, or withdrawing an application, must be completed through the system:
- In order to file Supplementary Materials/Appeals, an applicant should:
– upload supplementary or appeal documents to the system,
– download and print the cover page for these submissions, ensuring it is the first page of the supplementary/appeal documents;
– mail the paper originals (if applicable) to the FDA within three business days of the online submission. Submissions lacking the required cover page will not be accepted. - To proceed with a Withdrawal of Applications, an applicant should:
– submit withdrawal requests directly in the system;
– send an official document to the FDA specifying the electronic submission serial number/document number and the reason for withdrawal.
The abovementioned procedures have been introduced in order to ensure transparency and efficiency in handling post-submission activities.
Payment Options
According to the guidance, the system supports two payment methods, giving applicants the flexibility to choose between online and counter payment:
- Online Payment to be completed via the payment platform.
- Counter Payment, when an applicant can send a check or money order along with the submission cover page, stamped application form, and all required documents (including paper originals and discs, if applicable) to the FDA.
– In-Person Payment: Visit the FDA counter with a check, money order, or cash, along with the necessary documents.
If additional fees are required during the supplementary or appeal process, applicants must submit a stamped original copy of the supplementary fee explanation document.
Final Submission Confirmation
Under the general rule, after an application is submitted through the system, no modifications are allowed. Applicants must thoroughly review their submissions to ensure accuracy before finalizing them.
This measure prevents errors and ensures the efficient processing of applications.
Conclusion
In summary, the electronic submission system for second and third-class medical device registration provides a modern platform for applicants, simplifying the applicable regulatory procedures and establishing an efficient framework for placing new products on the market. The inclusion of web-based and offline submission options further provides additional flexibility for the applicants interested in marketing their products in Taiwan.
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