Page 76 - 2018食藥署年報(英文版)
P. 76

The Draft of Medical                                                Advancement in
                      Device Act                                              Management of Medical

             Advancing R&D and Product                                         Device & Consultation
             Innovation in the Medical
             Device Industry.                                                 Training 47 Seed Regulators in
                                                                              Medical Device Management.
             Promoting Diversified                                            Successfully Assisted 8
             Management of the Medical                                        Domestic Innovative Medical
             Device Industry.                                                 Devices into Market.

             Normalized Product Destination
             and Distribution Quality                                         20 Thousand Times Telephone
             Management.                                                      Counseling.
                                                                              739 Items of Medical Devices
             Consolidation of Medical Device
             Risk Management System.                                          Available for Online Sale.
                                                                              Successfully Assisted 4 Medical
             Medical Device Clinical Trials
             Management.                                                      Devices for Clinical Srials.

             Promoting Listed Medical Device                                  Guidelines for the 3D Printing
             Safety Surveillance Management.                                  of Medical Devices (Draft).










                New System for the                                              Cosmetic Hygiene

           Management of  Cosmetics                                              and Safety Act

             Additional Information                                            Scope of Management.
             Requirement for Nail Cosmetics.
                                                                               Proactive Report.
             Regulations Governing the
             Application of Animals Testing for                                Product Notification and
             Cosmetics or Cosmetic Ingredients.                                Product Information File
                                                                               System.
             Regulations Governing 15
             Ingredients such as Safrole that are                              Abolition of Criminal
             Ingredients Prohibited for Use in                                 Punishment & Increase of
             Cosmetic Products.                                                Administration Fines.
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