Medical Device in China: Which Class (I/II/III) and What Approval?

Definition: what "medical device class" means in China

In China, "which class" is the first question for any medical device — because the class determines the entire market-access path. The country runs a risk-based, three-tier system: Class I (low risk), Class II (moderate risk) and Class III (higher risk). The class is fixed by law in the Regulations on the Supervision and Administration of Medical Devices (医疗器械监督管理条例, State Council Order No. 739, as amended by Order No. 797 effective 20 January 2025), and the legal consequence is binary — Class I is filed, Class II and Class III are registered.

The single most useful thing to know: classification is catalog-driven, not negotiable by brand. You do not argue your way into a lower class; you find your product in the official Classification Catalog, and if it is not there, NMPA tells you the class.

The legal baseline: three classes, one statute

Article 6 of the Regulations defines the three tiers by risk:

• Class I — low risk; routine management ensures safety and effectiveness (e.g. surgical scissors, bandages, examination gloves, medical X-ray film).
• Class II — moderate risk; strict control is required to ensure safety and effectiveness (e.g. blood pressure monitors, thermometers, ECG machines, infusion sets, hearing aids).
• Class III — higher risk; special measures are needed throughout the lifecycle (e.g. cardiac pacemakers, vascular stents, artificial joints, artificial cochleae, haemodialysis machines, implantable devices).

The risk level is judged on intended purpose (预期目的), structural features (结构特征) and method of use (使用方法) — the same factors NMPA applies when it issues a classification determination.

The class is the gate. Everything else — dossier depth, review body, timeline, whether you need an in-China agent — flows from this one number.

How to determine the class: the decision tree

China runs a classification-rules-guided, catalog-first system. The practical order is:

1. Look it up in the Classification Catalog (医疗器械分类目录). The 2017 version (NMPA Announcement No. 104) took effect on 1 August 2018 and remains the master list, organised into 22 sub-catalogs with product descriptions, intended-use statements and example product names. The catalog is kept current through a dynamic adjustment mechanism (NMPA Announcement No. 60 of 2021), so it changes over time — for example Announcement No. 101 of 2023 adjusted 58 catalog entries, including upgrading certain soft-tissue ultrasonic scalpel heads and breast-biopsy devices to Class III.
2. If the catalog does not fit, use the Classification Rules (医疗器械分类规则, NMPA Order No. 15). These rules set the principles — for instance, a device supplied sterile is classed no lower than Class II, and an absorbable device is managed as Class III.
3. If still unclear, apply for a classification determination (分类界定). For newly developed products not yet in the catalog, Article 23 of the Regulations lets you either apply directly for Class III registration or ask NMPA to confirm the class — NMPA must decide within 20 working days. Where a product's attributes are genuinely ambiguous, this NMPA opinion is the authoritative answer.

What approval each class requires

Article 13 of the Regulations is the pivot: Class I = product filing (备案); Class II and Class III = product registration (注册). The filing/registration authority then depends on whether the device is made in China or imported.

| Class | Domestic (境内) | Imported (进口) | Mechanism | |-------|-----------------|-----------------|-----------| | Class I | Filing with municipal drug regulatory authority — effective on submission | Filing by the overseas filer's designated China agent with NMPA | Filing (备案) | | Class II | Registration with provincial drug regulatory authority | Registration with NMPA | Registration (注册) | | Class III | Registration with NMPA | Registration with NMPA | Registration (注册) |

These authority splits are codified in SAMR Order No. 47 (Measures for the Registration and Filing of Medical Devices, issued 26 August 2021, effective 1 October 2021), Article 8 — the implementing rule beneath the Regulations.

Imported devices: the two hard requirements

If you are an overseas brand, registration is gated by two rules in SAMR Order No. 47 that foreign teams routinely miss:

• You must appoint a China domestic agent. Article 14 requires the overseas applicant/filer to designate a China domestic enterprise legal person as its agent. That agent, not your overseas company, files with NMPA and assists you in meeting your legal obligations.
• You must show overseas marketing authorisation. Article 18 requires the certificate of marketing authorisation issued by the competent authority in the country where the device is registered or manufactured (the proof it is lawfully sold there). An innovative device not yet marketed overseas can be exempted from this document.

This is why "no local company" does not mean "no China presence." You do not need to incorporate a WFOE to register a device — but you do need a licensed mainland agent. That is a different, lighter structure than a full entity, and it is exactly the slot a Hong Kong trading entity plus a mainland importer-of-record arrangement fills.

Practical read: the device class decides the depth of approval; your entity structure decides who files. Most overseas brands register through a China agent while keeping the brand-owning layer offshore — see importing into China without a local company and using a Hong Kong entity to import.

Class II/III registration: what actually gets reviewed

Registration is a substantive review, not a notification. The dossier must demonstrate the device is safe, effective and quality-controlled, and typically includes: risk analysis, product technical requirements, test reports, clinical-evaluation data (with exemptions for mature products), labelling, and quality-system documentation. CMDE performs the technical review; the provincial or national authority then issues the administrative approval.

• Clinical evaluation is the usual rule (Art. 24), with exemptions for mature, well-understood products (e.g. devices with a long domestic track record and no serious adverse events).
• Review timeframes are set in working days at the CMDE level; real-world timelines stretch with supplementary-data rounds, so build buffer into any launch plan.
• The agency that regulates devices is NMPA (with provincial and municipal drug regulators handling Class II and Class I) — distinct from GACC (food), SAMR (non-device product standards) or CNCA (compulsory certification for some electronics). See our agency-map guide for the full split.

Where GOODSINFINITE fits the device path

For an overseas device maker, the bottleneck is rarely the science — it is the China-side operational layer: a licensed agent to file, the dossier in Chinese, and a compliant way to land and fulfil inventory. We run that layer so the class decision becomes a plan, not a blockage:

• China agent / importer of record. GOODSINFINITE TRADE LIMITED (Hong Kong) acts as your overseas trading counterparty; a mainland-licensed entity serves as the designated agent for filing/registration and clears customs as the importer of record.
• Compliance done upstream. Classification, registration/filing evidence, Chinese-language labels and HS coding are verified before the device ships — not argued over at the port.
• Five-city bonded fulfilment — Tianjin, Shanghai, Ningbo, Guangzhou, Qingdao — so registered devices reach customers fast after release.
• Deep-dive on the registration step. For the full dossier and CMDE review detail, see our China medical device registration guide.

Start by nailing the class: look up the catalog, and if it is ambiguous, get NMPA's determination early — because the class is what sets your clock, your cost and your authority.

FAQ

How do I know if my medical device is Class I, II or III in China? China uses a risk-based, catalog-driven system. Look the product up in the NMPA Classification Catalog (2017 version, Announcement No. 104, updated via dynamic adjustments such as Announcement No. 101 of 2023). If it is listed, the catalog states the class. If not listed or unclear, apply to NMPA for a classification determination; for new products NMPA decides within 20 working days. Class is driven by intended use, structure and method of use.

Does a Class I medical device need NMPA registration? No. Class I (low risk) is subject to filing (备案), not registration. A domestic Class I device is filed with the municipal drug regulatory authority and takes effect on submission. An imported Class I device is filed by the overseas filer's designated China agent with NMPA. Filing is record-keeping, not substantive review.

Who approves Class II and Class III registration? Class II is registered with the provincial drug regulatory authority. Class III, and all imported Class II and Class III devices, are registered with NMPA; CMDE performs the technical review. The registration certificate is valid for 5 years.

Can a foreign company register a device in China without a local entity? Not directly. Under SAMR Order No. 47, an overseas applicant must designate a China domestic enterprise legal person as agent and submit the overseas marketing-authorisation certificate. The China agent files with NMPA. A Hong Kong trading entity plus a mainland agent/importer of record satisfies this without forming a WFOE.

What is the difference between filing and registration? Filing (备案) applies only to Class I and takes effect on submission — it is a notification. Registration (注册) applies to Class II/III and is a substantive review by the authority, issuing a 5-year certificate. Registration is the real market-access gate for moderate- and high-risk devices.

Sources

• National Medical Products Administration (NMPA) — Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739, effective 1 June 2021; amended by Order No. 797, effective 20 January 2025), Art. 6, 13, 15, 16, 22, 23, 24: nmpa.gov.cn
• NMPA — Measures for the Registration and Filing of Medical Devices (SAMR Order No. 47, issued 26 Aug 2021, effective 1 Oct 2021), Art. 8, 14, 18: nmpa.gov.cn
• NMPA — Medical Device Classification Catalog (Announcement No. 104 of 2017, in force 1 Aug 2018): nmpa.gov.cn
• NMPA — Measures for the Dynamic Adjustment of the Medical Device Classification Catalog (Announcement No. 60 of 2021): nmpa.gov.cn
• NMPA — Adjustment of Parts of the Medical Device Classification Catalog (Announcement No. 101 of 2023): nmpa.gov.cn
• NMPA — Medical Device Classification Rules (NMPA Order No. 15): nmpa.gov.cn