Print Time:2022/01/24 12:24
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Chapter Law Content

Chapter II Accreditation and Management for Education and Training of Medical Device Technicians
Article 4
Any legal entity or organization with the intent to accept a commission to carry out education and training of technicians shall submit an application to the central competent authority with the following documents and information to apply for accreditation:
1. Certificates showing that the legal entity or organization has been established or registered for three full years.
2. Documents and information proving that the legal entity or organization’s quality of training and performance have been evaluated with the Talent Quality-management System (TTQS) by the Workforce Development Agency, Ministry of Labor and has received “Pass” or above or “Qualified“.
In the event that the central competent authority discovers that the aforementioned application documents and information are not complete, but corrections can be made, the central competent authority shall notify the applicant who shall make corrections within a prescribed period of time. In the event that the applicant fails to make corrections before the designated deadline, the application shall be rejected.
For the application referred to in the first Paragraph, after the application has been reviewed and approved, the central competent authority will issue certificate letter of accreditation and commission contract.
The aforementioned certificate letter of accreditation shall state the following information:
1. The name and address of the legal entity or organization.
2. The scope of accreditation.
3. Effective period of the accreditation.
Article 5
When a commissioned institution is commissioned to carry out education and training of technicians, the training program shall follow the provisions of Articles 5 and 11 of Regulations for Management of Medical Devices Technicians.
Within 7 days after completing each education and training program, the commissioned institution shall upload trainees’ names, national identification card numbers or numbers of the identification documents, the training program and number of training hours to the information system designated by the central competent authority.
Information and documents related to implementation of the above two commissioned tasks carried out by a commissioned institution shall be kept for three years; if any personal data is involved, the provisions of Personal Information Protection Act shall be followed.
Article 6
The central competent authority may conduct irregular audit to evaluate the commissioned institution regarding the content of the education and training and other relevant matters; the commissioned institution shall not evade, impede, or refuse such audit.
In the event that a commissioned institution is accredited through the use of false or inaccurate documents or information, or the employment of other illegitimate means, the central competent authority may revoke the accreditation and terminate the administrative contract for the commissioned education and training.
The central competent authority shall, under any of the following circumstances, notify the commissioned institution to make corrections within a prescribed period of time; In the event that the commissioned institution fails to make corrections before the designated deadline, its accreditation may be revoked and the administrative contract for the commissioned education and training may be terminated:
1. The training program provided by the commissioned institution violates the provisions of Paragraph 1 of the preceding Article.
2. The commissioned institution fails to follow the provisions of Paragraph 2 of the preceding Article to upload the required information before the designated date with the designated method, or the information provided are false or inaccurate.
3. The commissioned institution has violated the provisions of Paragraph 1 and has evaded, obstructed, or refused the audit conducted by the central competent authority.
Web site:Laws & Regulations Database of The Republic of China