QSD is a conformity assessment required for each individual foreign medical device manufacturer* to demonstrate the quality management system documentation is compliant with the regulatory requirements prior to market approval, unless specifically exempted by the competent authority.
Foreign manufacturers are required to apply for a QSD conformity assessment. The QSD Manufacturing License must be obtained before commencing production. Although the QSD application may be submitted concurrently with the medical device product registration or listing application, the Taiwan Food and Drug Administration (TFDA) require QSD approval before granting the product license or listing.
*According to the Medical Devices Act, medical device manufacturers are referring to businesses that fall into the following two types:
(1) Engaging in the manufacturing, packaging, labeling, sterilization, or final inspection and release of medical devices.
(2) Engaging in the design of medical devices and marketing the devices under their name.
*According to the Medical Devices Act, medical device manufacturers are referring to businesses that fall into the following two types:
(1) Engaging in the manufacturing, packaging, labeling, sterilization, or final inspection and release of medical devices.
(2) Engaging in the design of medical devices and marketing the devices under their name.
A QSD Manufacturing License is required for most foreign medical device manufacturers. However, manufacturers of some non-sterilized medical devices falling into the product items designated by the TFDA may be exempted from the requirement to obtain a manufacturing license. The list of these specific product items may be reviewed and updated by the TFDA.
There are two modes of QMS regulatory requirements, i.e., Standard Mode and Essential Mode. The Essential Mode is applicable only to manufacturers producing non-sterilized product items specified in the Annex of the Medical Device Quality Management System Regulations.
The key difference between the Standard and Essential Modes lies in the scope of regulatory compliance. Under the Essential Mode, manufacturers are subject to a limited set of regulatory requirements, resulting in exemption from certain QMS procedure documents.
Moreover, there are three Abbreviated Modes are specifically available for manufacturers located in the United States, the European region (including Switzerland and Liechtenstein), and Japan. Under this mode, manufacturers may submit documentation equivalent to Medical Device QMS Requirements (i.e., Certificate of Compliance with ISO 13485) and eligible audit reports to substitute certain documentation requirements.
Medical Device QMS Requirements
(Chapters 2 to 6 of Medical Device QMS Regulations)
Standard Mode (Article 4~77)
Essential Mode (Article 11, 12, 13, 47, 55, 64, 69, 76 and 77)
Abbreviated Application Modes
(Document Substitution / Exemption)
US Manufacturing Site
EU Manufacturing Site (TCP III)
Japanese Manufacturing Site
| Application Mode Required Docs | Standard NT$60,000 (US$2,000)/ Essential NT$30,000 (US$1,000) | |||
|---|---|---|---|---|
| Non-Abbreviated | Abbreviated | |||
| US Manufacturing Site | EU Manufacturing Site (TCPIII) | JP Manufacturing Site | ||
| Commonly Required Documents |
Administrative Documents | |||
| Manufacturing Process Diagrams | ||||
| Medical Device File List | ||||
|
Certificate of Compliance
QMS Cert
CFG/FSC/CFS
|
ISO 13485 | ISO 13485 (MDSAP) | ISO 13485 | ISO 13485 or QMS Cert |
| (CFG or FSC/CFS) | CFG | FSC/CFS | X | |
| Quality Manual | X | X | ||
| Quality SOPS | EIR/MDSAP Audit Report | Inspection report issued by EU NB partners | MDSAP Audit Report/QMS Inspection Report | |
| Document Master List | X | X | ||
| Plant Layout Diagram | X | X | ||
| Production Area Information | X | X | ||
| Main Manufacturing and Testing Equipment List |
X | X | ||
The manufacturing license will be issued to the applicants when the conclusion of the conformity assessment is compliance, which includes information about:
Manufacturing license reviewal is considered a form of re-registration. The renewal must be conducted every three years, with actions initiated 6 to 12 months before its expiry.
The renewed manufacturing license may maintain the previously approved scope. If needed, manufacturers may also add or remove registered product items and manufacturing activities, as long as the required documents are properly prepared and submitted.
All change applications do not extend the original expiry date and can be categorized into two types:
| Application | Fee | TFDA Turn-around Time announced |
|---|---|---|
|
New Application, Renewal, and Significant Change |
Standard NT$60,000 (US$2,000) |
120 calendar days |
|
Essential NT$30,000 (US$1,000) |
||
| Administrative Changes | NT$10,000 (US$333) | 60 calendar days |
The QSD conformity assessment is conducted by the Taiwan Food and Drug Administration (TFDA) in collaboration with designated assessment organizations. Currently, the designated organizations include:
