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                   Title Regulations for Governing the Management of Medical Device CH
     Amended Date 2019-07-29
              Category Ministry of Health and Welfare
         Attachment        Annex I.pdf
                           Annex II.pdf
                           Annex Ⅲ.pdf


                            Article Content        Article No Search          Content Search      Legislative History




  Article 1
  The present regulations are in accordance to the Article 13, Paragraph 2 of the Pharmaceutical Affairs Act.

  Article 2
  Medical device are classified into the following classes according to their level of risks:
  Class I : Low risk
  Class II : Medium risk
  Class III : High risk

  Article 3
  In accordance to the function, intended use, instruction for use and working principle, medical devices are classified into the following
  categories:
  1. Clinical Chemistry and Clinical Toxicology Devices
  2. Hematology and Pathology Devices
  3. Immunology and Microbiology Device
  4. Anesthesiology Devices
  5. Cardiovascular Devices
  6. Dental Devices
  7. Ear, Nose, and Throat Devices
  8. Gastroenterology and Urology Devices
  9. General and Plastic Surgery Devices
  10. General Hospital and Personal Use Devices
  11. Neurological Devices
  12. Obstetrical and Gynecological Devices
  13. Ophthalmic Devices
  14. Orthopedic Devices
  15. Physical Medicine Devices
  16. Radiology Devices
  17. Other Categories Specified by the National Health Competent Authority
  The classification of medical devices into the above categories is as Annex I.
  Annex I.pdf
 Article 4
 The manufacturing of medical devices shall comply with Part 3 Good Manufacturing Practice (GMP) for Medical Device of
 Pharmaceutical Good Manufacturing Practice Regulations.
 The manufacturing of medical devices listed in the Annex II of this regulation shall comply with Part 3 Chapter 3 Essential Mode of
 the GMP regulation, except the manufacturing of sterilized devices shall comply with Part 3 Chapter 2 Standard Mode of the GMP
 regulation.
 Annex II.pdf

 Article 5
 Medical devices that require clinical trial to be performed domestically are stated in Annex III.
 Annex Ⅲ.pdf

 Article 6
 Pharmaceutical entity or the general public may approach the National Health Competent Authority, through a payment service, for
 inquiry of the classification of a medical device and its regulatory control with the provision of the following:
 i. Instruction for use (or catalogue) and its Chinese translation in details (including the instruction for use, function and working
 principle).
 ii. Reference to classification of the product by the European Union or United State of America
 iii. Any other information as defined by the National Health Competent Authority.

 Article 7
 (deleted)

 Article 8
 The regulations shall be implemented on the date of announcement, except the manufacturing of Optical Impression Systems for
 CAD/CAM (Classification Number: F.3661) under the amendment of Article 3 Item 2 Annex 1 on January 7th, 2014, shall comply with
 this regulation from July 1st, 2014.
 The manufacturing of Quality Control Material (assayed and unassayed) (Classification Number: A.1660), Ear, Nose, and Throat
 Drug Administration Device (Classification Number: G.5220), and Corrective Spectacle Lens (Classification Number: M.5844) under
 the amendment of Article 3 Item 2 Annex 1 on June 3rd, 2015, shall comply with this regulation from September 1st, 2016.
 The manufacturing of Influenza virus antigen detection test system (Classification Number: C.3328), Surgical Gloves (Classification
 Number: I.4460), Patient Examination Gloves (Classification Number: J. 6250)" and Mechanical Wheelchair (Classification Number:
 O. 3850) under the amendment of Article 3 Item 2 Annex 1 on July 29th, 2019, shall comply with this regulation from July 29th, 2020.



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