Direct answer: A company website cannot replace the NMPA UDI database or the regulator's recall notices, but it can serve as a product-identification, IFU-download and after-sales entry point. Accept four things: models match the registration certificate, UDI data matches the database, recalls are not delayed, and IFU versions are traceable.
This guide is for Taizhou medical-device registrants/filers and manufacturers, plus marketing, regulatory affairs, quality, after-sales, IT, procurement and website vendors. It covers how to build and accept UDI product pages, recall/corrective-action pages and instructions-for-use (IFU) download pages. Information is current to 31 October 2026. It is public regulation and project method, not legal, registration or quality-system advice; registration/filing, UDI submission, recalls, IFUs and advertising are governed by the applicable regulations, NMPA requirements and the company's quality system.
Uploading UDI data to the NMPA database is a legal obligation; the website is only an auxiliary query point. Recall notices and notifications follow the regulator's statutory channels; the website cannot replace them. IFUs must match the registered/filed version, Chinese governs, and both current and superseded versions must be traceable.
Should the website carry UDI, recall and IFU pages?
It depends on what you sell and to whom. The website fits product identification, IFU downloads and after-sales. Statutory UDI submission and recall notices still belong to the NMPA database and regulatory channels.
A medical-device website is not a pile of certificate scans. Hospital procurement, distributors, importers and patients may fail to find a model, registration number, IFU or recall information, and end up calling sales. The website's value is to answer "what is this model, which certificate covers it, where is the IFU, has there been a recall or corrective action?" and reduce mismatches and repeated calls. But it is not a regulatory database: UDI data must be submitted to the NMPA database under the UDI System Rules, and recall notices/notifications must follow the Medical Device Recall Measures. The website can only mirror and link.
| Page/module | Answers | Authoritative source | Website role/common error |
|---|---|---|---|
| UDI product page | Which model/packaging, which registration or filing number | NMPA UDI database, registration/filing records | Auxiliary lookup; error: model mismatch or screenshots as data |
| Recall/corrective action | Which models/lots, why, what to do | NMPA/provincial recall notices | Mirror and entry point; error: news only, no lots or handling |
| IFU page | How to install, use, maintain, warnings | Registered/filed IFU | Version index and download; error: old versions unmarked, mixed languages |
| Distributor/after-sales lookup | Who sells, who repairs, how to report an event | Company authorisation and service system | Routing entry; error: public pricing or customer lists |
The page split is editorial; statutory requirements for UDI, recalls, IFUs and advertising follow the UDI System Rules, Medical Device Recall Measures, IFU and Labelling Provisions and the current Medical Device Supervision and Administration Regulation.
What is the minimum for a UDI product page?
At minimum: product name, model/specification, UDI-DI, packaging level, registration/filing number, data carrier and an NMPA database lookup link. Miss one and hospitals/distributors cannot match.
UDI consists of a device identifier (DI) and a production identifier (PI). A website product page does not need to list every lot's PI, but it must state which DI, model/specification, packaging level and registration/filing certificate the page corresponds to. The NMPA UDI database is publicly queryable; registrants/filers are responsible for the truth, accuracy and completeness of the data. The website can link to the database, but must not present a database screenshot as live company data. When a device stops being sold or used, its device identifier must not be reused for another device, and the website status must change accordingly.
| Element | What to write | Acceptance evidence | Common gap |
|---|---|---|---|
| Product name | Generic name; Class II/III matches the certificate | Registration/filing certificate | Trade name replacing generic name |
| Model/specification | Page model matches certificate, packaging and label | Model cross-reference | One page mixes several models |
| UDI-DI | Device identifier; packaging level stated | UDI database record | UDI without packaging level |
| Registration/filing no. | Number, validity, registrant/filer | Certificate scan/official lookup | Expired certificate still displayed |
| Data carrier | 1D/2D/RFID and human-readable form | Label sample | Only "has a code" |
| Database link | Link to the NMPA UDI database | Link test | Broken link or screenshot |
| Status | On sale/stopped; replacement model | Status record | Discontinued page stays live |
The UDI element list is editorial; UDI composition, data submission and post-discontinuation identifier rules follow the UDI System Rules; public lookup at the NMPA UDI database.
How should recall/corrective-action pages be accepted?
A recall page is not a news item. State the class, models/lots, cause, handling, notified parties and deadlines. The website only assists; it cannot replace statutory notices and notifications.
The Medical Device Recall Measures classify recalls as Class I, II and III, with notification deadlines: Class I within 1 day, Class II within 3 days and Class III within 7 days to distributors, users or patients. Class I notices are published on the NMPA website and central media; Class II/III notices on provincial regulator websites. A recall notice must include device name, model/specification, lot, cause, required action (e.g. suspend sale/use, forward the notice) and handling method. A company website can run a recall/corrective-action column, mirror notices and give hospitals/distributors a lookup and reporting entry, but cannot replace statutory notices, notifications and reports.
| Item | Requirement/suggestion | Evidence | Common failure |
|---|---|---|---|
| Recall class | Class I/II/III by defect severity | Recall decision/assessment | Class differs from the notice |
| Notification deadline | Class I 1 day, II 3 days, III 7 days | Notification log/timestamp | Website post treated as notification |
| Notice channel | NMPA/provincial regulator; website mirrors | Notice link/screenshot | Only posted on social media |
| Models/lots | Name, model, lot/serial number | Recall list | "Some products" |
| Cause | Defect facts, risk, how found | Investigation/assessment | Vague or blame-shifting |
| Handling | Warning/inspection/repair/relabel/software update/replacement/retrieval/destruction | Recall plan | "Contact sales" only |
| Contact/reporting | After-sales, quality, distributor/hospital reporting | Duty roster/form | Phone unanswered |
| Closure/review | Completion, effectiveness review, page status | Summary report | Page forever "ongoing" |
Recall classes, deadlines, channels and notice content are official rules in the Medical Device Recall Measures; website mirroring, columns and templates are editorial, and actual recall actions follow the quality system and regulator requirements.
How should IFU download pages be accepted?
The IFU must match the registered/filed content, Chinese governs, and the revision date and version must be shown. The download page must match model, language and version; old versions marked or retired.
The IFU and Labelling Provisions require the IFU to be scientific, true, complete, accurate and consistent with the registered/filed content; the text must be in Chinese, with other languages allowed but Chinese governing; the IFU generally includes the registration/filing number, technical-requirement number and compilation/revision date. The common website failures are "one PDF for every model", "new version uploaded but old version still downloadable" and "English version used as the Chinese version". Organise downloads by model/language/version, state the revision date and applicable models, and either label superseded versions as historical or retire them while keeping internal records.
| Item | Acceptance point | Evidence | Common failure |
|---|---|---|---|
| Content consistency | Matches the registered/filed IFU; no unauthorised edits | Certificate/filing comparison | Website "improves" the wording |
| Language | Chinese governs; foreign versions state language/market | Version list | English only or mixed |
| Version/date | Revision date, version, applicable models | File properties/footer | File named "final" |
| Model mapping | Correct file per model or series | Model-file matrix | One PDF for everything |
| Accessibility | Searchable PDF, opens on mobile, stable link | Test record | Non-searchable scan |
| Public boundary | Public/gated/distributor-only by commercial and compliance decision | Permission settings | Internal files made public |
| Old versions | Mark as historical or retire; keep internal record | Version log | Old version downloadable forever |
IFU content, language and revision requirements follow the IFU and Labelling Provisions; download structure, permissions and old-version handling are editorial, subject to the registered/filed documents and quality system.
How do you keep site data aligned with the NMPA database?
Name a single data source and owner, then update the site when the certificate/model/packaging changes. Mark discontinued products and never reassign an old UDI to a new device.
Website/database mismatches are usually not a technology problem but a missing "who updates it" owner. Map the registration/filing record, UDI database record, website product page, IFU PDF and distributor pack into one master-data table, with regulatory affairs or quality as the data owner and marketing/IT as publishers. Registration changes, new models/packaging, IFU revisions, discontinuation, recalls and distributor/after-sales changes should trigger a page update, with version, timestamp and approval record. For discontinued models, mark the status and replacement model instead of deleting the page and leaving old customers with nowhere to look.
| Change | Page action | Evidence | Risk |
|---|---|---|---|
| Registration change | Update number/validity/model/IFU | Change document, approval | Old number displayed |
| New model/packaging | Add UDI-DI and packaging level | Database record | New packaging has no page |
| IFU revision | Replace, date, handle old version | Version log | Old and new coexist unmarked |
| Discontinuation | Mark status, replacement, service plan | Status record | Old UDI reused for new device |
| Recall/corrective action | Mirror notice, lots, handling | Recall record | Site silent/delayed |
| Distributor/service change | Update contact, territory, reporting | Authorisation/service agreement | Customers cannot reach anyone |
The change list is editorial; UDI data maintenance and post-discontinuation identifier rules follow the UDI System Rules; registration/filing changes follow the Medical Device Supervision and Administration Regulation and NMPA requirements.
What should distributors, hospitals and patients be able to query?
Collect only necessary fields, never patient information. Tier access by role and log downloads/lookups. Do not publish internal pricing or customer lists.
A common over-design is "register before you can look up a UDI", collecting phone, hospital, department and patient details without stating purpose or retention. UDI/IFU lookup usually does not need patient information. If you need contact details for after-sales or recall follow-up, state the purpose, scope, retention and sharing, and follow the PIPL. Distributor pricing, hospital lists and unpublished recall investigation material do not belong on public pages; use login/authorisation to separate public and distributor versions. Lookup/download logs should answer who looked up which model and when, without recording sensitive information unrelated to the purpose.
| Audience | Needs | Website provides | Do not |
|---|---|---|---|
| Hospitals/users | Model, registration, IFU, recall/corrective action | Public lookup + after-sales entry | Require patient details first |
| Distributors | Authorisation, pricing, stock, training | Authorised login/partner pack | Publish floor prices/customer lists |
| Patients/public | Intended use, contraindications, IFU, recall | Plain-language page + official links | Diagnosis/efficacy promises |
| Regulators/auditors | Complete records, versions, traceability | On-request/audit access | Assemble evidence last minute |
The lookup/privacy list is editorial; personal-information processing, notice, consent and minimisation follow the PIPL and the company privacy policy.
What about multilingual and export pages?
The Chinese site follows Chinese registration/filing and UDI. Export pages follow the target market separately; do not treat Chinese UDI as EU/US identifiers or mix claims.
Many Taizhou device makers serve both domestic and export markets. Multilingual is not translating the Chinese page: China's UDI database, EU UDI/EUDAMED and US GUDID are different systems, and registration, IFU language, labelling and recall requirements differ. An English page can describe products, applications and company capability, but registration status, UDI, certification and recall content must be checked per market. Do not mix a Chinese registration number, Chinese UDI or "CE/FDA" claims. Do not display a certification logo or "certified" without evidence; have regulatory affairs and legal review export claims.
| Page | Can say | Verify first | Do not say |
|---|---|---|---|
| Chinese product page | China registration/filing, UDI, IFU, recall | Number/model/database | Unapproved indications |
| English product page | Product capability, applications, company | Target-market registration/label/language | Chinese certificate as overseas registration |
| Export compliance page | Certifications/registrations actually held | Scope/validity/notified body | Vague "international certified" |
| Recall page | Notice/entry for the relevant market | Local regulator channel/language | China notice only |
The multilingual checklist is editorial; China registration/filing and IFU requirements follow the Medical Device Supervision and Administration Regulation and IFU and Labelling Provisions; export-market requirements follow local rules and notified bodies, not this article.
Launch acceptance checklist
Accept eight items: page scope, UDI elements, registration/filing number, recall template, IFU version, data consistency, privacy/access and change/retirement. Each needs an owner and evidence.
This checklist can be shared by regulatory affairs, quality, marketing, after-sales, IT, procurement and vendors. The pass standard is not "the page is built" but that hospitals/distributors find the right model, the IFU is current, recall information is not delayed, data matches the database, old models are explained and privacy is respected.
| Check | Pass standard | Evidence | If failed |
|---|---|---|---|
| Page scope | UDI/recall/IFU/after-sales entries exist and are separated | Sitemap/page list | Add pages/split modules |
| UDI elements | Name/model/UDI-DI/packaging/number/carrier complete | Model cross-reference | Add data/change template |
| Number consistency | Registration/filing number, validity and registrant match | Certificate/official lookup | Retire old certificate/update |
| Recall template | Class/lots/cause/handling/contact/deadline complete | Template + drill | Add template/training |
| IFU version | Model-mapped, revision date, Chinese governs, old versions handled | Version matrix | Replace/retire old version |
| Data consistency | Site matches NMPA database/registration | Sampling record | Fix data/add checks |
| Privacy/access | Lookup collects only what is needed; public/login tiers; logs | Field/permission table | Remove fields/change access |
| Change/retirement | Registration/model/discontinuation/recall triggers updates; expired pages retired | Change log/status | Add process/owner |
The acceptance checklist is editorial; specific UDI, recall, IFU, registration/filing and information-processing requirements follow regulations, NMPA requirements, the quality system and the contract.
Who should read this, who should not, and what decision does it support?
It fits Taizhou medical-device registrants/filers and teams building UDI, recall or IFU pages. It does not fit teams without registration/quality data or those wanting the website to replace regulatory channels.
Who should read: regulatory affairs, quality, marketing, after-sales, IT, procurement and website vendors at Taizhou medical-device companies; teams building or redesigning a website and deciding "what goes on the UDI page, how recalls are mirrored, how IFUs are delivered, how discontinued models are handled, what export pages may say". Who should not: projects without registration/filing information or a quality/recall process; teams expecting the website to replace the NMPA database or regulator notices; teams treating the site as an e-commerce listing and optimising only for conversion. Decisions supported: page scope, UDI elements, recall template, IFU versions, data consistency, privacy/access, multilingual boundaries and launch acceptance.
Lingyi Information is a website and enterprise AI project services company, not a medical-device registration/regulatory body, quality-system certifier or law firm. This article does not replace registration/filing, UDI submission, recall, IFU review or legal advice. Taizhou projects are confirmed case by case for remote or on-site work; Lingyi is one candidate, not a local office/team, and does not promise registration approval, recall immunity, traffic or inquiries.
FAQ
Must the website publish UDI?
The rules require registrants/filers to create and maintain UDI and submit the device identifier and related data to the NMPA UDI database before marketing; the database is publicly queryable. Whether the company website publishes UDI is a separate decision; it is usually an auxiliary lookup and after-sales need, confirmed with regulatory affairs and commercial/channel strategy.
Can the website publish its own recall notice?
It can mirror one, but cannot replace statutory notices and notifications. Class I notices go on the NMPA website and central media; Class II/III on provincial regulator websites; companies must notify distributors, users or patients within 1/3/7 days. The website fits mirroring, lookup and reporting.
Can IFU PDFs be public?
It depends on whether the file matches the registered/filed IFU, contains commercially sensitive information and is intended for the public. Public downloads should state model, language and version/revision date; old versions should be marked or retired. Internal files and distributor pricing should not be public; confirm with regulatory affairs and legal.
How does UDI-DI relate to the registration number?
They are different. UDI-DI identifies the registrant/filer, model/specification and packaging; the registration/filing number identifies the certificate. The website should map them, but must not use UDI-DI in place of the registration number or apply one certificate to every model.
How should discontinued products be handled?
Mark the discontinued/stopped status, last sale/service arrangement and replacement model; keep historical IFUs and recall information. Do not delete the page, and do not reuse an old UDI for a new device; the UDI rules prohibit using a stopped device's identifier for another device.
Should export pages show EUDAMED/FDA information?
Follow the target-market rules and actual registration status. China UDI, EU UDI/EUDAMED and US GUDID are different systems and must not be mixed; do not display a logo or "certified" without evidence. Have regulatory affairs and legal review export pages before launch.
Bottom line
For a Taizhou medical-device website, statutory UDI data and recall notices stay with the NMPA/regulator; the site provides auxiliary lookup, version indexing and after-sales entry. Accept that models match certificates, UDI matches the database, recalls are not delayed, IFU versions are traceable and privacy stays in bounds.
Method and limits
This article is public regulation and project method, not a compliance certification or legal advice for any company, product, registration/filing, recall, IFU or website. It uses no unpublished client registration data, recall records or contracts. Page structure, tables and the acceptance checklist are editorial suggestions; UDI, recall, IFU, registration/filing, advertising and information-processing requirements follow current regulations, NMPA requirements, the quality system and legal counsel.
Sources
Information is current to 31 October 2026; each official/primary page governs its own scope, version and clauses.
- Rules for the Unique Identification System for Medical Devices (effective 1 October 2019): gov.cn. UDI composition, data submission, public database lookup and post-discontinuation identifier rules.
- Measures for the Administration of Medical Device Recalls (effective 1 May 2017): gov.cn. Recall classes, 1/3/7-day notification deadlines, notice channels and content.
- Regulation on the Supervision and Administration of Medical Devices (effective 1 June 2021): gov.cn. Higher-level basis for registration/filing, production, operation and recall responsibility.
- Provisions for the Administration of Medical Device Instructions and Labels (effective 1 October 2014): gov.cn. IFU consistency with registration/filing, Chinese governing, revision date and prohibited claims.
- NMPA Medical Device UDI Database: udi.nmpa.gov.cn. Public lookup entry; the website should link, not substitute with screenshots.