China follows a risk-based classification system for medical devices, similar to the EU and US, but with local distinctions. Classification directly impacts the regulatory pathway, documentation requirements, and review timeline.

	Class I — Low Risk Definition: Devices that present minimal risk to users and can be effectively regulated through routine oversight. Pathway: Filing (recordation) with NMPA; no technical review required. Examples: Surgical gloves, face masks, thermometers. Review Time: Typically 1–3 months. Clinical Data: Generally not required.
	Class II — Moderate Risk Definition: Devices with moderate risk requiring stricter control to ensure safety and effectiveness. Pathway: Full registration, including technical review by CMDE and administrative approval by NMPA. Requirements: Product Technical Requirements (PTR) Type testing reports (preferably from China-certified labs) Clinical Evaluation Report (CER) or local clinical data (if not exempt) Examples: Blood pressure monitors, urinary catheters, diagnostic ultrasound systems. Review Time: Typically 9–15 months, depending on data readiness
	Class III — High Risk Definition: Devices that are life-supporting, implanted into the body, or pose significant potential risk Pathway: Full registration with extensive documentation and clinical data. Requirements: Extensive technical and safety documentation Mandatory clinical trial data (unless exempted or bridged) Testing in China may be required Examples: Cardiac pacemakers, orthopedic implants, high-risk IVDs. Review Time: 12–24 months or more, depending on complexity.

 Why Classification Matters

• Determines whether a product requires filing or full registration

• Impacts the need for local testing and clinical trial

• Affects time-to-market and cost planning

If you're unsure how your product is classified under NMPA, BiomenGroup can assist with classification confirmation and strategy before submission.

→ [Ask Us About Classification Strategy →]

China registrant system/Market Authorization Holder

MAH (Market Authorization Holder) – legal entity holding the NMPA registration certificate and responsible for the medical device’s safety, quality, and post-market obligations. This term is the standard translation in China’s regulatory context for medical devices

For imported medical devices, the foreign manufacturer is considered the Market Authorization Holder (MAH) in substance, while the China Legal Agent is the designated local representative required for regulatory operations.

Key distinctions:

The MAH is the actual product owner and assumes full responsibility for product safety, quality, and post-market obligations.

The Legal Agent is a local Chinese company authorized by the MAH to handle registration, communication with NMPA, and post-market surveillance within China.