0A4F4F9BD490A749D5437F821CF06DF1
Regulations for Governing the Management of Medical Devices
https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030054
http://leaux.net/URLS/ConvertAPI Text Files/0720C15B467E7C0B379DACAEDF33A0B6.en.txt
Examining the file media/Synopses/0720C15B467E7C0B379DACAEDF33A0B6.html:
This file was generated: 2020-08-23 05:50:20
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.(None): The manufacturing of medical devices listed in the Annex II of this regulation shall comply with Part 3 Chapter 3 Essential Mode of
p.(None): the GMP regulation, except the manufacturing of sterilized devices shall comply with Part 3 Chapter 2 Standard Mode of the GMP
p.(None): regulation.
p.(None): Annex II.pdf
p.(None):
p.(None): Article 5
p.(None): Medical devices that require clinical trial to be performed domestically are stated in Annex III.
p.(None): Annex Ⅲ.pdf
p.(None):
p.(None): Article 6
p.(None): Pharmaceutical entity or the general public may approach the National Health Competent Authority, through a payment service, for
p.(None): inquiry of the classification of a medical device and its regulatory control with the provision of the following:
p.(None): i. Instruction for use (or catalogue) and its Chinese translation in details (including the instruction for use, function and working
p.(None): principle).
p.(None): ii. Reference to classification of the product by the European Union or United State of America
p.(None): iii. Any other information as defined by the National Health Competent Authority.
p.(None):
p.(None): Article 7
p.(None): (deleted)
p.(None):
p.(None): Article 8
p.(None): The regulations shall be implemented on the date of announcement, except the manufacturing of Optical Impression Systems for
p.(None): CAD/CAM (Classification Number: F.3661) under the amendment of Article 3 Item 2 Annex 1 on January 7th, 2014, shall comply with
p.(None): this regulation from July 1st, 2014.
p.(None): The manufacturing of Quality Control Material (assayed and unassayed) (Classification Number: A.1660), Ear, Nose, and Throat
p.(None): Drug Administration Device (Classification Number: G.5220), and Corrective Spectacle Lens (Classification Number: M.5844) under
p.(None): the amendment of Article 3 Item 2 Annex 1 on June 3rd, 2015, shall comply with this regulation from September 1st, 2016.
p.(None): The manufacturing of Influenza virus antigen detection test system (Classification Number: C.3328), Surgical Gloves (Classification
p.(None): Number: I.4460), Patient Examination Gloves (Classification Number: J. 6250)" and Mechanical Wheelchair (Classification Number:
p.(None): 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.
p.(None):
p.(None):
p.(None):
p.(None): News Law Convention
p.(None): Searching Justices of the Constitutional Court
p.(None):
p.(None):
p.(None): E-PAPER
p.(None): enter your email address
p.(None):
p.(None):
p.(None): Subscribe
p.(None):
p.(None):
p.(None): Unsubscribe
p.(None):
p.(None):
p.(None): This website does not provide legal counseling service, please contact with related public offices for more information.
p.(None): In case of any discrepancy between the English version and the Chinese version, the latter shall prevail.
p.(None):
p.(None):
p.(None): │ Government Website Open Information Announcement │ Declaration on Privacy Right Protection │ Information Security Policy │ EMail │
p.(None): OPERATING BY THE WORKING GROUP OF THE R.O.C LAWS & REGULATIONS DATABASE, MINISTRY OF JUSTICE.
p.(None): NO. 130, Sec. 1, Chongqing S. Rd., Taipei, 10048, Taiwan(R.O.C.)
p.(None): Service Phone-Call: +886-2-2191-0189
...
Social / Property Ownership
Searching for indicator home:
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p.(None): Search SEARCH
p.(None):
p.(None): : Location Home > Law > Article Content
p.(None): P
p.(None):
p.(None): Article Content
p.(None):
p.(None):
p.(None):
p.(None): Title Regulations for Governing the Management of Medical Device CH
p.(None): Amended Date 2019-07-29
p.(None): Category Ministry of Health and Welfare
p.(None): Attachment Annex I.pdf
p.(None): Annex II.pdf
p.(None): Annex Ⅲ.pdf
p.(None):
p.(None):
p.(None): Article Content Article No Search Content Search Legislative History
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Article 1
p.(None): The present regulations are in accordance to the Article 13, Paragraph 2 of the Pharmaceutical Affairs Act.
p.(None):
p.(None): Article 2
p.(None): Medical device are classified into the following classes according to their level of risks:
p.(None): Class I : Low risk
p.(None): Class II : Medium risk
p.(None): Class III : High risk
p.(None):
p.(None): Article 3
p.(None): In accordance to the function, intended use, instruction for use and working principle, medical devices are classified into the following
p.(None): categories:
p.(None): 1. Clinical Chemistry and Clinical Toxicology Devices
p.(None): 2. Hematology and Pathology Devices
p.(None): 3. Immunology and Microbiology Device
p.(None): 4. Anesthesiology Devices
p.(None): 5. Cardiovascular Devices
p.(None): 6. Dental Devices
p.(None): 7. Ear, Nose, and Throat Devices
p.(None): 8. Gastroenterology and Urology Devices
p.(None): 9. General and Plastic Surgery Devices
p.(None): 10. General Hospital and Personal Use Devices
p.(None): 11. Neurological Devices
p.(None): 12. Obstetrical and Gynecological Devices
p.(None): 13. Ophthalmic Devices
p.(None): 14. Orthopedic Devices
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): 9. General and Plastic Surgery Devices
p.(None): 10. General Hospital and Personal Use Devices
p.(None): 11. Neurological Devices
p.(None): 12. Obstetrical and Gynecological Devices
p.(None): 13. Ophthalmic Devices
p.(None): 14. Orthopedic Devices
p.(None): 15. Physical Medicine Devices
p.(None): 16. Radiology Devices
p.(None): 17. Other Categories Specified by the National Health Competent Authority
p.(None): The classification of medical devices into the above categories is as Annex I.
p.(None): Annex I.pdf
p.(None): Article 4
p.(None): The manufacturing of medical devices shall comply with Part 3 Good Manufacturing Practice (GMP) for Medical Device of
p.(None): Pharmaceutical Good Manufacturing Practice Regulations.
p.(None): The manufacturing of medical devices listed in the Annex II of this regulation shall comply with Part 3 Chapter 3 Essential Mode of
p.(None): the GMP regulation, except the manufacturing of sterilized devices shall comply with Part 3 Chapter 2 Standard Mode of the GMP
p.(None): regulation.
p.(None): Annex II.pdf
p.(None):
p.(None): Article 5
p.(None): Medical devices that require clinical trial to be performed domestically are stated in Annex III.
p.(None): Annex Ⅲ.pdf
p.(None):
p.(None): Article 6
p.(None): Pharmaceutical entity or the general public may approach the National Health Competent Authority, through a payment service, for
p.(None): inquiry of the classification of a medical device and its regulatory control with the provision of the following:
p.(None): i. Instruction for use (or catalogue) and its Chinese translation in details (including the instruction for use, function and working
p.(None): principle).
p.(None): ii. Reference to classification of the product by the European Union or United State of America
p.(None): iii. Any other information as defined by the National Health Competent Authority.
p.(None):
p.(None): Article 7
p.(None): (deleted)
p.(None):
p.(None): Article 8
p.(None): The regulations shall be implemented on the date of announcement, except the manufacturing of Optical Impression Systems for
p.(None): CAD/CAM (Classification Number: F.3661) under the amendment of Article 3 Item 2 Annex 1 on January 7th, 2014, shall comply with
p.(None): this regulation from July 1st, 2014.
p.(None): The manufacturing of Quality Control Material (assayed and unassayed) (Classification Number: A.1660), Ear, Nose, and Throat
p.(None): Drug Administration Device (Classification Number: G.5220), and Corrective Spectacle Lens (Classification Number: M.5844) under
p.(None): the amendment of Article 3 Item 2 Annex 1 on June 3rd, 2015, shall comply with this regulation from September 1st, 2016.
p.(None): The manufacturing of Influenza virus antigen detection test system (Classification Number: C.3328), Surgical Gloves (Classification
p.(None): Number: I.4460), Patient Examination Gloves (Classification Number: J. 6250)" and Mechanical Wheelchair (Classification Number:
p.(None): 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.
p.(None):
p.(None):
p.(None):
p.(None): News Law Convention
p.(None): Searching Justices of the Constitutional Court
p.(None):
p.(None):
p.(None): E-PAPER
p.(None): enter your email address
p.(None):
p.(None):
p.(None): Subscribe
p.(None):
p.(None):
p.(None): Unsubscribe
p.(None):
p.(None):
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): Category Ministry of Health and Welfare
p.(None): Attachment Annex I.pdf
p.(None): Annex II.pdf
p.(None): Annex Ⅲ.pdf
p.(None):
p.(None):
p.(None): Article Content Article No Search Content Search Legislative History
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Article 1
p.(None): The present regulations are in accordance to the Article 13, Paragraph 2 of the Pharmaceutical Affairs Act.
p.(None):
p.(None): Article 2
p.(None): Medical device are classified into the following classes according to their level of risks:
p.(None): Class I : Low risk
p.(None): Class II : Medium risk
p.(None): Class III : High risk
p.(None):
p.(None): Article 3
p.(None): In accordance to the function, intended use, instruction for use and working principle, medical devices are classified into the following
p.(None): categories:
p.(None): 1. Clinical Chemistry and Clinical Toxicology Devices
p.(None): 2. Hematology and Pathology Devices
p.(None): 3. Immunology and Microbiology Device
p.(None): 4. Anesthesiology Devices
p.(None): 5. Cardiovascular Devices
p.(None): 6. Dental Devices
p.(None): 7. Ear, Nose, and Throat Devices
p.(None): 8. Gastroenterology and Urology Devices
p.(None): 9. General and Plastic Surgery Devices
p.(None): 10. General Hospital and Personal Use Devices
p.(None): 11. Neurological Devices
p.(None): 12. Obstetrical and Gynecological Devices
p.(None): 13. Ophthalmic Devices
p.(None): 14. Orthopedic Devices
p.(None): 15. Physical Medicine Devices
p.(None): 16. Radiology Devices
p.(None): 17. Other Categories Specified by the National Health Competent Authority
p.(None): The classification of medical devices into the above categories is as Annex I.
p.(None): Annex I.pdf
p.(None): Article 4
p.(None): The manufacturing of medical devices shall comply with Part 3 Good Manufacturing Practice (GMP) for Medical Device of
p.(None): Pharmaceutical Good Manufacturing Practice Regulations.
p.(None): The manufacturing of medical devices listed in the Annex II of this regulation shall comply with Part 3 Chapter 3 Essential Mode of
p.(None): the GMP regulation, except the manufacturing of sterilized devices shall comply with Part 3 Chapter 2 Standard Mode of the GMP
p.(None): regulation.
p.(None): Annex II.pdf
p.(None):
p.(None): Article 5
p.(None): Medical devices that require clinical trial to be performed domestically are stated in Annex III.
p.(None): Annex Ⅲ.pdf
p.(None):
p.(None): Article 6
p.(None): Pharmaceutical entity or the general public may approach the National Health Competent Authority, through a payment service, for
p.(None): inquiry of the classification of a medical device and its regulatory control with the provision of the following:
p.(None): i. Instruction for use (or catalogue) and its Chinese translation in details (including the instruction for use, function and working
p.(None): principle).
p.(None): ii. Reference to classification of the product by the European Union or United State of America
p.(None): iii. Any other information as defined by the National Health Competent Authority.
p.(None):
p.(None): Article 7
p.(None): (deleted)
p.(None):
p.(None): Article 8
p.(None): The regulations shall be implemented on the date of announcement, except the manufacturing of Optical Impression Systems for
p.(None): CAD/CAM (Classification Number: F.3661) under the amendment of Article 3 Item 2 Annex 1 on January 7th, 2014, shall comply with
p.(None): this regulation from July 1st, 2014.
p.(None): The manufacturing of Quality Control Material (assayed and unassayed) (Classification Number: A.1660), Ear, Nose, and Throat
p.(None): Drug Administration Device (Classification Number: G.5220), and Corrective Spectacle Lens (Classification Number: M.5844) under
p.(None): the amendment of Article 3 Item 2 Annex 1 on June 3rd, 2015, shall comply with this regulation from September 1st, 2016.
p.(None): The manufacturing of Influenza virus antigen detection test system (Classification Number: C.3328), Surgical Gloves (Classification
p.(None): Number: I.4460), Patient Examination Gloves (Classification Number: J. 6250)" and Mechanical Wheelchair (Classification Number:
p.(None): 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.
p.(None):
p.(None):
p.(None):
p.(None): News Law Convention
p.(None): Searching Justices of the Constitutional Court
p.(None):
p.(None):
p.(None): E-PAPER
p.(None): enter your email address
p.(None):
p.(None):
p.(None): Subscribe
p.(None):
p.(None):
p.(None): Unsubscribe
p.(None):
p.(None):
p.(None): This website does not provide legal counseling service, please contact with related public offices for more information.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| drug | Drug Usage |
| home | Property Ownership |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
justice
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input