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Quality System Documentation (QSD) For US Medical Device Manufacturing Site

Abbreviated Application Mode for the Quality System Documentation (QSD) Conformity Assessment – US Medical Device Manufacturing Site

During the effective period of the “Technical Cooperation Programme between Taiwan and the United States on Medical Device Regulation”, medical device manufacturers located in the United States, Puerto Rico, or Guam, may apply for a Quality Management System (QMS) conformity assessment under an abbreviated application mode.

These manufacturers may submit an Establishment Inspection Report (EIR) issued by the U.S. Food and Drug Administration (FDA) within the past three years, along with a Certificate to Foreign Government (CFG). These documents may serve as substitutes for the quality-related documentation typically required.

If a U.S. FDA inspection report within the past three years is not available, the manufacturer may instead submit:

  • An audit report issued by a recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP)
  • A written explanation stating that the manufacturer has not been inspected by the U.S. FDA within the past three years

Notes for the Abbreviated Mode: US Manufacturing Site

  • Specific Documents Required:
  1. Certificate to Foreign Government (CFG)
  2. ISO 13485 Certificate
  3. Audit Report (EIR, MDSAP)
  4. Manufacturer’s Declaration
Certificate to Foreign Government (CFG)
  1. Must be an original copy
  2. Shall be issued within two years prior to the application date
  3. A reference table should be included if multiple items are involved
  4. Must clearly state the actual manufacturing site in the  “manufacturer” field
Common Requirements for CFG, CFS, or FSC Used in US and EU Abbreviated Applications or QSD Essential Mode Applications:
  1. Must be an original copy. Authentication is not required.
  2. Must be issued within the last two years.
  3. Must clearly state the actual manufacturing site under “manufacturer” or “production site”. The name and address must match the information submitted in the QSD application.
  4. All product items included in the QSD application must be covered and supported by the CFG, CFS, or FSC. If multiple items are included, or if the product names are not clearly identifiable in the certificate, it is recommended to provide a comparison table to clarify the correlation.
Audit Report (EIR)
  • The manufacturer’s name and address must match those listed in the application form
  • The report must have a final inspection date within three years prior to the date the application is received by the TFDA
  • The Manufacturer’s Declaration must specify the date of the most recent FDA inspection
  • The report must include a valid signature from the FDA investigator (e-signatures are acceptable)
  • If any observations are noted in the report, the corresponding Corrective and Preventive Actions (CAPA) must be submitted
  • For new registration or subsequent extension applications, the audit report must cover at least one of the newly registered or additionally added items

Audit Report (MDSAP)

Must be issued by a recognized Auditing Organization under the MDSAP program

The final inspection date must be within one year prior to the date the application is received by the TFDA

An original copy of the Manufacturer’s Declaration must be submitted. It must include:

  • The most recent FDA inspection date
  • Confirmation that no FDA inspection has been conducted within the past three years

The audit type must be one of the following: Initial, Surveillance #1, Surveillance #2, or Recertification

The audit report must follow the MDSAP AU F0019.1 format

The review criteria are aligned with those for the EIR report