Regulations for Governing the Management of Medical Device

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

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

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 Devices2. Hematology and Pathology Devices3. Immunology and Microbiology Device4. Anesthesiology Devices5. Cardiovascular Devices6. Dental Devices7. Ear, Nose, and Throat Devices8. Gastroenterology and Urology Devices9. General and Plastic Surgery Devices10. General Hospital and Personal Use Devices11. Neurological Devices12. Obstetrical and Gynecological Devices13. Ophthalmic Devices14. Orthopedic Devices15. Physical Medicine Devices16. Radiology Devices17. Other Categories Specified by the National Health Competent AuthorityThe classification of medical devices into the above categories is as Annex I.Annex I.pdf

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

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

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 Americaiii. Any other information as defined by the National Health Competent Authority.

(deleted)

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.