Devices from Hong Kong, China, Macao, China and Taiwan, China: Registration Rules

1. Key takeaways

In projects from Hong Kong, China, Macao, China and Taiwan, China, fees and timelines are the most common misjudgement. Companies schedule them like domestic projects, then find the acceptance level, agent requirement and fee tier all diverge at once. Setting these three out at kick-off beats explaining a budget overrun afterwards.

• The legal basis is a single reference clause: Article 123 of the Measures provides that registration and filing of devices from Hong Kong, China, Macao, China and Taiwan, China are handled by reference to imports.
• The import reference triggers four rules together: an enterprise legal person within China as agent; origin marketing approval documents; Class I filing and Class II and III registration by the NMPA; agent information in instructions and labels.
• The acceptance level matches imported products: all handled by the NMPA (Regulations, Articles 15(2) and 16(2)).
• Fees follow the imported tier: imported Class II first registration CNY 210,900, Class III CNY 308,800; variation CNY 42,000 and CNY 50,400 respectively; renewal uniformly CNY 40,800.
• Origin marketing documents are handled in three tiers: sale-permitting documents where marketed locally; market access documents where not regulated locally as a medical device; none for innovative devices not marketed outside China (Article 18).
• Chinese remains mandatory: instructions and labels in Chinese; other languages may be added, but Chinese prevails (Order No. 6, Article 9).

In our assessment, the acceptance level, agent arrangement and fee tier all diverge from domestic precedent simultaneously; a clear kick-off explanation is worth more than a post-overrun one.

2. Legal basis

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

• Article 16, paragraph 2: for Class II and III exported to China, the dossier and overseas marketing approval documents go through a designated enterprise legal person within China; innovative devices not marketed outside China may be exempted.
• Article 20, paragraph 1: the obligations of registrants and filers.
• Article 20, paragraph 2: the designated enterprise legal person assists in performing them.

Medical Device Registration and Filing Measures (SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021)

• Article 5: the Center for Medical Device Evaluation of the NMPA reviews domestic Class III, imported Class II and III registration, variation and renewal applications.
• Article 8, paragraphs 5 and 6: imported Class I filings go to the NMPA; Class II and III are approved by the NMPA before certification.
• Article 17: dossiers shall be in Chinese; translated material must include the original text.
• Article 120: fee items and standards follow the finance and price authorities of the State Council.
• Article 14, paragraph 2: overseas applicants shall designate an enterprise legal person within China as agent to handle registration and filing matters and assist in implementing legal responsibilities.
• Article 18: documents from the competent authority of the country or region of registration or manufacture permitting sale shall be submitted; innovative devices not marketed outside China need no submission.
• Article 41: all deficiencies notified at once, supplied within 1 year; failing that, review is terminated and the application rejected.
• Article 123: registration and filing of devices from Hong Kong, China, Macao, China and Taiwan, China are handled by reference to imported devices.

Provisions on the Administration of Medical Device Instructions and Labels (former CFDA Order No. 6, promulgated 30 July 2014, effective 1 October 2014), Article 10(2): imported instructions shall also state the agent’s name, domicile and contact details. Article 15 of the Unique Device Identification System Rules (NMPA, 2019): identifiers uploaded before marketing.

Practical estimate. Notarisation and legalisation routes for such documents differ from those for foreign documents. Confirm the form at project start against current requirements and Announcement No. 121 of 2021, reserving the processing period.

Practical estimate. Handled by reference to imports is procedural and does not change the fact of origin. In publicity, marking and customs documents, companies should still declare the actual origin truthfully.

3. Expert insights

Insight 1: one reference clause triggers the entire import rule system. Article 123 connects the whole pathway:

Handled by reference means the entire pathway is treated as an import.

Insight 2: acceptance moving up to the NMPA is the change to prepare for. The difference is not in dossier content but in the accepting authority:

The difference is most pronounced for Class II: domestic goes to the provincial department, the reference route to the NMPA. The counterpart moves from provincial to national, the channel to the CMDE, and communication pace adjusts. Centralised review also unifies acceptance criteria.

Insight 3: the agent — an enterprise established in the Chinese mainland may serve, but independence must be satisfied. Where such a registrant has a subsidiary in the Chinese mainland, that subsidiary is an independent enterprise legal person and may serve. Three points:

1. Legal person status: representative and liaison offices lack legal person status and do not qualify.
2. Independence: the subsidiary is independent in law; its acting as agent does not affect the registrant’s responsibility.
3. Completeness of authorisation: the power of attorney must cover registration and filing matters and assisting the registrant’s obligations.

The common error is treating a sales team or an office as the agent; such bodies are returned at acceptance.

Insight 4: two special points in the three-tier handling of origin documents.

First, an EU CE certificate or a US FDA clearance cannot substitute for the local marketing approval document. Holders of other overseas licences should first determine whether the product has a marketing position locally; if not marketed outside China and innovative, claim the third-tier exemption.

Second, the tier order cannot be reversed: marketed locally first, then not regulated as a medical device, only last the innovation exemption.

4. Practical recommendations

• Explain the import reference consequences thoroughly at kick-off, writing the three differences into the project initiation document.
• Confirm the agent early and complete the authorisation: an enterprise legal person lawfully established in the Chinese mainland, power of attorney covering both duties; representative and liaison offices excluded.
• Assess origin documents in the three-tier order, the innovation exemption only last.
• Distinguish local marketing approval from other overseas licences; a CE certificate or FDA clearance cannot replace the local document.
• Confirm the notarisation and legalisation route early, reserving the processing period.
• Build a terminology concordance table against the Classification Catalogue and applicable mandatory standards before finalisation.

5. Verification checklist

• □ Article 123 applicability confirmed: registration and filing handled by reference to imports.
• □ Accepting authority confirmed as the NMPA (Class I filing, Class II/III).
• □ Technical review body confirmed as the CMDE (Article 5).
• □ An enterprise legal person within China designated; representative and liaison offices excluded.
• □ Power of attorney issued, covering registration and filing matters and Article 20(1) obligations.
• □ Origin documents assessed in the three-tier order, or the innovation exemption confirmed.
• □ Local marketing approval document obtained, not substituted by a CE certificate or FDA clearance.
• □ Notarisation and legalisation form confirmed.
• □ Dossiers in Chinese, original text for translated material (Article 17).
• □ Terminology compared against the Catalogue and mandatory standards,

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 acts as the in-China registration agent, coordinates import agent and distributor arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com