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106 SINGAPORE: HSA to Revamp Existing Product Registration Submission Guidance – January 2019 378
107 SINGAPORE: HSA Summarizes Important Updates for Guidance Document on Essential Principles of Safety and Performance of Medical Devices – January 2019 288
108 SINGAPORE: HSA Shares Plans on Revising Medical Device Registration Dossier Guidelines – January 2019 405
109 THAILAND: Amendment to the Guidelines for Preparation of Documents (CDST) for Non-IVD Device and for Medical Devices – January 2019 422
110 THAILAND: Announcement of the Food and Drug Administration Regarding Criteria for Grouping Medical Devices – January 2019 357
111 VIETNAM: VN MOH Issued New Decree to Amend and Supplement Decree - January 2019 1113
112 TAIWAN: TFDA green-lights QSD Simplified Application Routes to support Japanese Manufacturers - December 2018 614
113 Qualtech Japan Offers DMAH Services: Let Us Assist You to Set Foot in the Japanese Market - December 2018 532
114 CHINA: NMPA Publishes Draft Guidelines of the Biological Evaluation for Medical Devices - Part 1: The General Principles – December 2018 516
115 CHINA: CMDE Publishes Draft Guideline for the Reprocessing Validation and Labeling for Reusable Medical Devices : Part 1 - December 2018 429
116 INDONESIA: Digital Signature Implementation - December 2018 435
117 MALAYSIA: New Guidance Document for Requirements for Application of Certificate of Free Sale (CFS) For Export Only Medical Devices - December 2018 511
118 MALAYSIA: 3rd Edition of Guidance Document for Requirements for Labelling of Registered Medical Device - December 2018 386
119 MALAYSIA: 3rd Edition of Guidance Document for Change Notification for Registered Medical Device - December 2018 346
120 6 Things You Have to Know When Your Medical Device Undergoes the China Registration Process: Non-Active Medical Device Part - November 2018 441
 
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