Application for Good Distribution Practice (GDP) Conformity Assessment for Domestic Manufacturers of Medical Devices

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GXP Inspection & Lab Accreditation

【Update Date：2023-05-24】unit：品質監督管理組

Introduction:

According to Article 24 of the "Medical Devices Act", for medical devices announced by the central competent authority and their dealers, a medical device good distribution system shall be established to govern the product storage, distribution, services, personnel deployment, and other related operational matters, and shall comply with the regulations for good distribution practice of medical devices.

Medical device dealers shall set up a good distribution system of medical devices in accordance with the regulations set forth in the preceding paragraph, and the wholesale, import, or export may only begin after receiving a compliance inspection by the central competent authority and obtaining a distribution license.

Regulations for the good distribution practice set forth in Paragraph 1, and regulations governing the content and methods of inspection, the requirements, procedures, review, issuance, validity period, revocation, or cancellation of approval referred to in the preceding paragraph, and other matters to be complied with shall be established by the central competent authority.

How to apply:

Create a user account on the "Medical Device Quality Management System application platform" and submit the application online.

How to renew the distribution license:

According to Article 5 of the "Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License", the validity of the distribution license would be effective for a period of 3 years. For application renewal, if necessary, shall be made between 6 and 12 months prior to expiration, and each extension period is limited to 3 years.

Who should apply a change:

According to Article 4 of the "Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License", changing the name, address of the medical device dealer, the distribution operation items or storage location(s) of the medical device, shall submit the application by sending the application form to TFDA.