Which regulatory holder is actually changing?
For a foreign manufacturer and its Taiwanese successor distributor, the useful starting question is not “Can we change the agent?” It is “Which name appears on each regulatory record?” A commercial distributor, product-license holder and QSD applicant may be the same firm, but they need not be. The Medical Devices Act separates product market authorization, the persons allowed to import, and the manufacturer’s quality-system requirements. 2
Make a transition register before agreeing a shipping cutover. Ask the current local partner for the product authorization numbers, the QSD approval and its expiry, and the evidence authorizing the proposed importer. Record the legal names rather than trade names. This is a document-control recommendation: the legal rules attach to the actual registrations and authorizations, not to the label “exclusive distributor” in a commercial contract.
| Record | Question to resolve | Consequence for the transition |
|---|---|---|
| Product license or listing | Who holds the authorization for each device or model? | Assess the separate product filing if that holder or other registered particulars change. A QSD transfer does not transfer product authorization. 2 7 |
| Authorized importer | Is the proposed importing firm the product-license holder, listing party or their authorized person? | Article 25(3) permits those persons to import. A manufacturer’s sales appointment alone does not demonstrate authorization from the current product holder. 2 |
| Foreign-factory QSD approval | Which Taiwanese dealer is recorded, for which site and approved scope? | If the recorded dealer changes, examine TFDA item (七), importer transfer. If the holder remains, identify whether another registered item actually changes. 1 3 |
Source: Medical Devices Act, Articles 22 and 25–26; QMS Inspection Regulations, Article 5; TFDA change instructions.
A product-license holder change is a separate application category under Article 13 of the product-license regulations. The same regulations distinguish a license-holder change from a distributor-name change on labeling, and limit a listing-party name change to cases without rights transfer. Do not assume a product listing can simply be transferred using the QSD procedure. Have the local regulatory lead identify the correct product-level route for each authorization. 7
Keeping an independent local firm as product holder can reduce the need to transfer that particular record when sales distributors change. It does not settle who holds the QSD file or whether the incoming importer has the required authorization. Conversely, a distributor change does not by itself prove that all three records must change. Build the register around the actual before-and-after entities, then identify the applications needed.
Where does importer transfer sit in TFDA’s change list?
TFDA’s change page combines domestic manufacturing-permit changes and foreign-factory QSD changes. Its numbered order matters when a Taiwanese applicant locates the relevant instructions: importer transfer is item (七), not item (六); foreign-factory street-number reassignment is item (六). The route map below follows the live official page. These are document summaries, not a substitute for its complete lists or the regulations’ Appendix 2. 1 5
| TFDA item | Change event | Document or route distinction |
|---|---|---|
| (一) / 1 | Domestic factory name; site unchanged | Change form, manufacturing-permit copy and medical-device business-permit copy. 1 |
| (二) / 2 | Domestic factory address; street-number reassignment only | Change form, permit copy and original evidence from a household-registration or other relevant official authority. 1 |
| (三) / 3 | Domestic factory name involving rights transfer | The page lists business-permit evidence, an original transfer deed and original manufacturer authorization. Appendix 2 also identifies an unchanged-QMS declaration for this event. 1 5 |
| (四) / 4 | Domestic management representative | Change form, permit copy and a copy of the evidence appointing the management representative. 1 |
| (五) / 5 | Foreign factory name; site unchanged | Approval copy, original manufacturer change notice, and original name-change evidence from the origin country’s highest health authority or manufacture/free-sale evidence. The page specifies a two-year document window and free-sale coverage of at least half the originally approved items. 1 |
| (六) / 6 | Foreign factory address; street-number reassignment only | Approval copy, original manufacturer change notice and original official address-reassignment evidence from the country of origin. 1 |
| (七) / 7 | Transfer of the importing dealer on the foreign-factory approval | Original holder completes the form. Approval copy, original dealer transfer deed and original manufacturer authorization are listed; Appendix 2 also marks the dealer business-permit copy. 1 5 |
| (八) / 8 | QSD holder’s name changes without an agency transfer | Change form, approval copy and medical-device business-permit copy. Do not use this as the route for replacing one legal entity with another. 1 |
| (九) / 9 | Factory relocation, authorized-item or operational-content change | Use the applicable inspection provisions. Article 5 requires a new Article 2 application for relocation and applies Articles 2–3 procedures to authorized-item or operation changes. 1 3 |
Source: TFDA Quality Supervision Division change page and QMS Inspection Regulations, Article 5 and Appendix 2.
The page and Appendix 2 present the dossier at different levels of detail. In particular, the web list for importer transfer does not repeat the business-permit copy marked in Appendix 2. Assemble against both, and reconcile any differences with the current portal requirements or TFDA before submission. A shorter website list should not be read as permission to omit a document required by the regulation’s appendix. 1 5
What belongs in the QSD importer-transfer file?
For item (七), TFDA explicitly says the original QSD holder completes the application form. It separately lists a transfer deed issued by the medical-device dealer and an authorization issued by the foreign manufacturer. Those documents serve different purposes. Sending only a new manufacturer appointment letter leaves the published transfer-deed requirement unaddressed. 1
- Change application form: identify the original holder as the party responsible for completing the form, and agree who will coordinate any questions with the successor.
- Existing approval copy: reconcile the approved factory, holder, scope and expiry against the transition register. The published document requirement is a copy of the QSD approval, not surrender of the original approval letter.
- Dealer business-permit copy: include the evidence indicated for an authorization transfer in Appendix 2 and confirm the applicable entity details against the filing instructions.
- Original transfer deed: obtain the dealer’s deed transferring the foreign-factory quality-system approval. Do not treat a generic commercial termination email as the deed.
- Original manufacturer authorization: describe termination of Dealer A’s authorization and registration under Dealer B, with the transferred items and both parties’ addresses. Appendix 2 specifies issuance within the most recent year. 1 5
The two official texts phrase the time condition differently: the TFDA page describes the authorization as valid for one year, while Appendix 2 says it must have been issued within the most recent year. Either way, plan the signing date so the letter is less than a year old when the file is submitted, and have it reissued if the filing slips. The condition applies to the letter, not to the length of the distributor contract. 1 5
Use a drafting review to compare dealer identities, addresses and item descriptions across the authorization, deed and approval. Adding legal names and a clear reference to the existing approval is sensible document control. However, the cited instructions do not establish universal requirements for bilingual company names, corporate seals, consular legalization, notarization or a particular signatory title. Confirm any additional execution requirement for the actual dossier instead of presenting these preferences as TFDA rules.
If the outgoing holder will not cooperate, record precisely which required document or filing action is unavailable and obtain a case-specific route from TFDA and qualified Taiwanese regulatory counsel. A private transfer promise, power of attorney or escrow clause should not be assumed to override TFDA’s application requirements. Do not schedule successor imports on the assumption that a pending dispute is already resolved.
Did the factory move, or did its address change administratively?
“The address changed” is not enough to select the procedure. Article 5 limits the manufacturer-address change route to street-number reassignment. If the factory relocates, a new application is required under Article 2. For changes to authorized items or content of operations, Article 5 instead applies the application and inspection procedures in Articles 2 and 3. These are distinct rules; not every scope amendment should be described as a brand-new factory registration. 3
| Event | Evidence to collect | Filing implication |
|---|---|---|
| Same factory; official street-number reassignment | Original manufacturer change notice and original evidence from a relevant official authority in the origin country. | Foreign-factory item (六). Reconcile old and new address descriptions without implying a physical move. 1 |
| Factory physically relocates | Exact old/new sites and affected manufacturing activities, supported by the manufacturer’s change records. | New application under Article 2. Confirm the required dossier and inspection method for that site. 3 |
| Approved items or operations change | A clear description of the scope difference and the affected approval. | Application and inspection procedures under Articles 2–3 apply. Do not file as a simple holder-name correction. 3 |
| Dealer changes but factory and scope remain | Existing approval, original holder’s transfer documents and manufacturer authorization. | Assess item (七), together with the separate product and import records. 1 3 |
Source: QMS Inspection Regulations, Article 5; TFDA items (六), (七) and (九).
A foreign-factory name change at an unchanged site has its own dossier under item (五). The official page specifies a two-year condition for the relevant origin-country certificate and requires manufacture/free-sale evidence covering at least half the original approved items. This is not a requirement to obtain a new free-sale certificate for every ordinary importer transfer. If both factory name and importer change, identify both events rather than dropping one into the other’s dossier. 1
For checking a certificate’s issuer, product coverage and legal-manufacturer identity, use our free-sale certificate verification guide. For this Taiwan filing, the event-specific TFDA document list remains the controlling reference; a certificate accepted elsewhere does not establish acceptance here.
Which deadlines, fees and expiry dates should the team track?
Article 5 requires changes to the specified registered items—manufacturer name, limited address changes, domestic management representative and foreign-device importer—to be filed within 30 days of the actual occurrence, with the application, documents and fee. It does not provide a general grace period for importing a device whose product authorization or importer qualification is unresolved. Product-registration changes subject to Act Article 26 have their own approval requirement. 2 3
For a transition with multiple commercial and regulatory dates, record the event chronology and ask the responsible local regulatory lead to confirm the occurrence date used for the filing deadline. The cited rule does not say that every case starts on contract signature or termination-letter signature. Resolve this before the cutover rather than assuming a single trigger date.
| Item | Verified rule | Planning implication |
|---|---|---|
| Ordinary QSD registered-item change | File covered changes within 30 days of occurrence. TFDA lists NT$10,000; the fee standard separately lists ordinary manufacturing-permit changes at that amount. | Budget this filing separately from product-license, import-authorization and professional-service costs. 1 3 6 |
| Late registered-item change | Act Article 70(4) addresses change-rule violations under Article 22(4), with an NT$30,000–1,000,000 fine range. | This is statutory exposure, not an automatic invoice for a particular late case. Escalate missed deadlines promptly. 2 |
| QSD validity and renewal | Article 6 provides three-year validity and an application window between six and twelve months before expiry. Article 5 says the specified changes do not extend original validity. | Keep the renewal workstream active during the transfer. A change receipt does not reset expiry. 3 |
| Timely renewal still awaiting a decision | Article 6 provides continued effect until decision where the application was timely and the delay is not attributable to the manufacturer. | Verify that those conditions apply; do not assume every pending renewal or late filing has continued effect. 3 |
Source: QMS Inspection Regulations, Articles 5–6; Medical Devices Act, Article 70(4); TFDA change page; Fee Standards, Article 2.
Physical relocation and scope changes have different fee categories from ordinary administrative changes, and an overseas on-site inspection has its own charges and possible additions. Obtain the fee assessment for the selected procedure. The ordinary QSD change fee is not a total price for transferring a product portfolio, and this guide does not promise an approval turnaround. 6
Likewise, do not confuse product-license validity with the QSD term. Act Article 27 provides product-license validity of no more than five years; listed products instead have an annual-declaration framework under Article 28. Read the actual authorization and expiry before assigning renewal actions. 2
How does the electronic filing notice affect the documents?
TFDA letter FDA品字第1151102276號, dated April 14, 2026, states that from May 1, 2026, QMS/QSD and GDP conformity submissions are completed electronically through the Medical Device Quality Management Application Platform. Forms and materials are entered or uploaded there; paper correspondence and application forms no longer need to be mailed. Original documents must be retained by the manufacturing or distribution permit holder. 4
This later notice matters because the change webpage, maintained in November 2025, still describes downloading a form and sending documents, with a paper exception for certain legacy cases. Read that historical submission wording alongside the later electronic-filing notice, and confirm the current platform instructions for the particular change. Do not infer that online submission abolishes the original-document requirements in the dossier. 1 4
For the handoff, assign responsibility for portal access, submission evidence, deficiency correspondence and custody of originals. These are recommended controls, not published TFDA requirements. For technical upload requirements, use the operating manual that the notice says is available on the platform home page. 4
Taiwanese source dates may use the Minguo calendar. Add 1911 to the displayed Minguo year: year 115 is 2026. Thus the notice’s 115年5月1日 corresponds to May 1, 2026. Keep the original notice number in the file as well as the Gregorian date so colleagues can locate the same instrument. 4
A working handoff plan for the manufacturer and both dealers
Use the following as an internal coordination sequence, not a regulator-issued timetable. Parallel filing may be appropriate; the local regulatory lead should confirm dependencies and whether the proposed importer may operate under the current authorizations. A submission receipt demonstrates a submitted case, not completion of every product, QSD and import requirement.
- Inventory the current holdings. List every product authorization and its holder, the authorized importer and the relevant QSD approval, factory site, scope and expiry. Identify records that remain unchanged.
- Define the actual events. Distinguish a sales appointment, QSD importer transfer, holder-name correction, product-license holder change, factory renumbering and physical relocation. Assign the correct route to each.
- Confirm cooperation before the cutover. Name the person at the outgoing QSD holder who will complete the form and arrange the transfer deed. Assign the manufacturer authorization and supporting-document review.
- Agree the filing calendar. Record occurrence dates, the statutory change deadline, submission responsibilities and the separate renewal window. Escalate ambiguous dates before relying on them.
- Reconcile the dossier. Compare the current portal checklist, TFDA event list and Appendix 2. Preserve required originals and document who holds them after electronic submission.
- Review product and import readiness separately. Confirm the necessary product filing and the incoming importer’s Article 25(3) authority. Check the dealer business permit and whether the actual devices and activities fall within the announced GDP scope.
- Verify the returned decisions. Reconcile the approved holder, site, items and expiry against the transition register, and retain any unresolved conditions. Obtain regulatory sign-off before relying on the new arrangement for shipments.
- Complete the commercial handoff. Assign inventory records, customer contacts, complaint routing, quality agreements and original-document access. Record these as business controls rather than claiming the QSD transfer completes them automatically.
The legal checks underlying that plan come from Act Articles 13, 24–26 and the QMS change rules. GDP obligations attach to announced device categories and dealers; this guide does not classify every sterile consumable as GDP-designated. Ask for the applicability basis and relevant approval where required. 2 3
For partner selection and document-control discussions before signing, see our distributor-program qualification guide. During a Taiwan transition, add this record-by-record filing assessment to that broader commercial review.
Where VEMERIX fits—and where due diligence still begins
VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.
A distributor considering a VEMERIX sterile-device line can use this guide to specify the evidence needed for its own Taiwan assessment. Start with VEMERIX quality information and the document library, then request the product-specific documentation discussion. State the proposed legal manufacturer, device, factory, current local holder and intended change. These links do not establish that a particular Taiwan license, QSD approval, distributor appointment or filing-ready dossier exists.
Questions to settle before the distributor cutover
Does changing a sales distributor always require a QSD transfer?
No automatic conclusion follows from the sales agreement. Article 5 concerns changes to registered particulars. Read the actual approval: if the recorded QSD holder changes, assess item (七); if it remains the same, determine whether another registered item changes. Product and import records still need their own checks. 1 3
Can the new distributor submit only the manufacturer authorization?
That is not the published transfer dossier. TFDA calls for the original holder’s completed change form, approval copy, original dealer transfer deed and original manufacturer authorization. Appendix 2 also identifies a medical-device business-permit copy. 1 5
Does a holder-name correction cover a new legal entity?
TFDA item (八) is explicitly for a holder-name change without agency transfer. Do not substitute it for item (七) merely because both result in a different displayed name. Establish whether the legal holder remains the same. 1
Does the QSD transfer extend the approval?
The change rule does not extend the original validity. Renewal is a separate Article 6 workstream; check its window and any applicable continued-effect conditions rather than assuming that a pending transfer protects the expiry. 3
Can a new importer ship while applications are pending?
Pending applications alone do not establish readiness. Article 25(3) recognizes the product-license holder, listing party or their authorized persons as importers. Confirm that basis and all other applicable product, dealer and quality-system conditions for the actual shipment; this guide grants no interim import permission. 2
Is an address reassignment the same as a factory move?
No. For a foreign factory, TFDA item (六) is limited to official street-number reassignment and requires the manufacturer change notice and official evidence. Actual relocation calls for a new Article 2 application. 1 3
Scope, interpretation and recheck triggers
This guide translates and organizes published rules for an existing foreign-factory file; it is not an opinion on a particular dispute, penalty or shipment. Chinese legal text controls where an English translation differs. The QMS manufacturing-permit framework contains announced product exemptions under Act Article 22, so product-specific applicability must be verified rather than inferred from a broad class label. 2 3
Recheck the official change instructions, Appendix 2, fee standard and platform notices before filing, and whenever the factory, holder, approved scope or expiry changes. The key decision remains factual: determine what changed, identify the regulatory record affected, and obtain the evidence for that procedure. Keeping those records distinct makes the commercial transition reviewable without promising TFDA approval or uninterrupted imports.