Print Time:2022/01/24 11:25
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Chapter Law Content

Chapter I General Provisions
Article 1
The Regulations are enacted pursuant to Paragraph 2 of Article 79 of the Medical Devices Act (hereinafter referred to as the Act).
Article 2
Terms used in the Regulations shall have the following meanings:
1. Commissioned institution: It refers to an agency (or institution), a legal entity or an organization commissioned by the competent authority to carry out the tasks set forth in Paragraph 1 of Article 79 of the Act.
2. Accreditation: It refers to the procedure carried out by the competent authority to verify that a legal entity or an organization has the ability to carry out the tasks set forth in Paragraph 1 of Article 79 of the Act.
Article 3
When the central competent authority commissions another agency (or institution) to carry out education and training of technicians and inspection of medical device firms in accordance with the provisions of Paragraph 1 of Article 79 of the Act, the rights and duties of both parties shall be determined with administrative contracts.
When the central competent authority commissions a legal entity or an organization to carry out commissioned tasks referred to in the preceding Paragraph in accordance with the provisions of Paragraph 1 of Article 79 of the Act, the legal entity or organization shall apply for accreditation for each commissioned task in accordance with the provisions of the Regulations.
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