China UDI: Three Implementation Batches, Scope and Database Maintenance

1. Key takeaways

The unique device identification (UDI) consists of two parts — the device identifier (UDI-DI) and the production identifier (UDI-PI) — a structure fixed by Article 7 of the Rules for the Unique Identification System for Medical Devices.

• Upload is a pre-marketing act: Article 15 requires the holder or filer to upload the identifier and related data to the UDI database before the product is placed on the market.
• Implementation has advanced in three batches: Announcement No. 106 of 2020 covering part of Class III; Announcement No. 114 of 2021 covering the remaining Class III devices, including IVDs; Announcement No. 22 of 2023 covering 15 categories and 103 Class II varieties.
• The scope is defined at the level of the secondary product category under a sub-catalogue of the Classification Catalogue. Judging scope by catalogue heading or primary category is the commonest technical error.
• Class II devices selected in centralised procurement but outside the implementing list are not yet mandatory. Selection alone does not bring a product into scope.
• The issuing agency must meet Article 10; the choice determines how complete the database fields will be.
• Catalogue adjustments — four batches, 123 entries since 2020 — can change a product’s secondary category and therefore its UDI scope.

2. Legal basis

Administrative regulation. Medical Device Supervision and Administration Regulation (State Council Order No. 739), promulgated 9 February 2021, effective 1 June 2021.

• Articles 13: Class I filed, Class II and III registered, with lifecycle liability for holder and filer.
• Article 20, paragraph 1: five duties, including traceability and recall; paragraph 2: the designated Chinese legal entity assists in these duties.

Departmental rules. Measures for the Administration of Medical Device Registration and Filing (SAMR Order No. 47), promulgated 26 August 2021, effective 1 October 2021.

• Article 14, paragraph 2: the overseas applicant or filer designates a Chinese legal entity as agent, to assist in the Article 20 duties. Article 15: quality system.
• Article 123: registration and filing of devices from Hong Kong, Macao and Taiwan follows the imported-device route.

Production rules. Measures for the Supervision and Administration of Medical Device Production (SAMR Order No. 53), promulgated 10 March 2022, effective 1 May 2022. Article 4: production is classified, Class II and III requiring a licence, Class I a filing. Article 36: UDI requirements (wording outside the verification scope here; the text in force governs).

Normative documents. Rules for the Unique Identification System for Medical Devices (2019): Article 7 on composition, Article 10 on issuing agencies, Article 15 on upload before marketing. Announcement No. 106 of 2020 (first batch); No. 114 of 2021, 17 September 2021 (second); No. 22 of 2023 (third).

Practical estimate. Scope for all three batches is determined at the secondary product category under a sub-catalogue, so the category must be located before the batch lists are checked. On issuing-agency lists, deadlines for database field changes and catch-up entry of historical data, no verifiable official rule is held here; the requirement in force must be confirmed with the UDI database administration at NMPA.

3. Expert insights

DI and PI divide the maintenance workload. Article 7 splits the identifier into a static part, pointing to model, specification and holder, and a dynamic part pointing to batch, serial, production and expiry dates.

The workload is lopsided: DI turns on synchronising change, PI on system integration. As a one-off coding project, UDI fails on the PI side: the rule sits in the quality manual while the execution system generates no PI accordingly, so label, database and product disagree.

The three batches follow risk from high to low and categories from narrow to broad.

Bringing IVDs into the second batch shows the line is risk and management necessity, not device versus reagent. The third batch names 103 varieties rather than covering the class: Class II enters variety by variety, so scope must be checked product by product.

Class II status also shifts with catalogue adjustments: four batches, 123 entries since 2020 (2025 Annual Medical Device Registration Work Report, NMPA, 24 February 2026). After an adjustment the secondary category may change, so the earlier conclusion is rechecked.

The exemption boundary belongs here too: Class II devices selected in centralised procurement but outside the list are not yet mandatory. The test is the batch list — Class III in the first or second batch, Class II among the 103 varieties, Class II outside it not mandatory even if selected, Class I not covered. Voluntary implementation after selection is the enterprise’s decision.

Upload precedes sale, and therefore precedes shipment. Article 15 sets the point as before the product is placed on the market, which means upload completes before the first shipment, not alongside it and certainly not afterwards.

The third row is the one most often compressed: once shipment is planned, upload becomes paperwork rather than a precondition, and the first consignment leaves before the database holds a record. A hard upload-confirmation release gate is the only reliable safeguard.

The issuing and upload chain for an overseas holder. Article 20, paragraph 2 and Article 14, paragraph 2 put the landing on the China agent, and in UDI the agent’s tasks weigh more than in ordinary filing.

The difficulty sits in the second row: field requirements follow domestic rules, and data prepared to home-country habits often cannot be entered directly. Sending the field requirements to headquarters at project start beats correcting at upload (practical estimate).

4. Practical recommendations

• Determine scope before starting, checking each secondary category against all three batch lists and recording the conclusion and its date.
• Split DI and PI into two sub-projects: certificate change triggering DI synchronisation, and validation of execution-system coding before label design.
• Select the issuing agency against Article 10, with domestic field completeness as one criterion.
• Make upload a hard release condition with a completion checkpoint in the shipment process.
• Set a recheck trigger for catalogue adjustments; with four batches and 123 entries since 2020, review at least annually (practical estimate).
• Send field requirements early, translating the domestic field list before the agency is contracted.
• Verify label, database and product agree, sampling after production switching or label revision.

5. Verification checklist

• □ Scope determined variety by variety at secondary category level
• □ Determination cites all three announcements (2020 No. 106, 2021 No. 114, 2023 No. 22)
• □ Class II products checked against the 15 categories, 103 variety list
• □ Issuing agency meets Article 10
• □ Coding rules for UDI-DI and UDI-PI written into system documents (Article 7)
• □ Identifier and data uploaded before marketing (Article 15)
• □ Release process carries an upload completion checkpoint
• □ Certificate changes trigger a DI data recheck
• □ Execution system can generate UDI-PI by batch, and has been validated
• □ Label, database and product sampled and confirmed consistent
• □ Selected-but-unlisted Class II products handled as not yet mandatory, with a note on file
• □ Secondary category and scope conclusion rechecked after catalogue adjustments

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Chinese market. Our team manages adverse event monitoring and recall filings with NMPA, maintains UDI compliance, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com