Page 160 - 2023 Taiwan Food and Drug Administration Annual Report
P. 160

2023 Taiwan Food and
Drug Administration

Annual Report

     Serial  Name of the                 URL               Brief Introduction                               QR Code

     number Website in English

             Post-marketing quality                        This system allows the general public,
                                                           healthcare professionals, and manufacturers
     25      management system Https://qms.fda.            to report adverse events of medicinal products,
             for medicinal products, gov.tw                medical devices, health foods, and cosmetics
                                                           and serves as an integrated one-stop reporting
             food and cosmetics                            portal that realizes quick reporting.

     26      Cosmetic Products       Https://cos.fda.gov.  To ensure that the management regulations
             Notification Platform   tw                    of cosmetics are in line with international
                                                           standards and regulations and to ensure
                                                           that government agencies can keep
                                                           track of products available on the market,
                                                           manufacturers or importers of cosmetics are
                                                           required to provide product information on the
                                                           “Cosmetic Products Notification Platform.”

              Online Application     https://oap.fda.gov.  The system provides online application
     27 System of Human              tw/B105/              for the human organ bank, to ensure the
                                                           completeness of submitted documents
              Organ Bank                                   and enhance the application efficiency and
                                                           regulatory compliance through its reminder
                                                           function.

             Materials Transfer                            This system provides online reporting of

     28      Support System for      http://mrdss.fda. medical supply reserves for both public and
             Disaster Rescue and     gov.tw/login.aspx private hospitals, assisting in the allocation of

             Prevention                                    medical resources during major disasters.

     29      Laboratory              Https://lams.fda.     TFDA’s accreditation platform for food, drug,
             Accreditation           gov.tw                cosmetic, and drug abuse urine testing
             Management System                             institutions.

     30      Laboratory information Https://lims.fda.      The system provides online application
             management system gov.tw                      for human organ bank, to ensure the
                                                           completeness of submitted documents
                                                           and enhance the application efficiency and
                                                           regulatory compliance through its reminder
                                                           function.

     31      Medical Device          http://mdqms.fda.     The platform that allows domestic and
             Quality Management      gov.tw                international medical device suppliers to apply
             Application Platform                          for quality system inspections.

                                                           This system allows businesses to submit

             The E-submission                              applications electronically for registration

     32      System for Registration https://mds.fda.gov. and market approval of Class 2 and Class

             and Market Approval of tw/                    3 medical devices, change of license, and

             Medical Devices                               extension of license. Reviewers of TFDA can

                                                           also review the applications on the system.

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