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How SFDA Classification Works

Overview​

The SFDA classifies medical devices using a risk-based system that is closely aligned with the EU Medical Device Regulation (EU MDR 2017/745). The classification rules are set out in MDS-REQ 1 and interpreted through the guidance document MDS-G008.

Classification is the manufacturer's responsibility. The correct risk class determines:

  • The depth of technical documentation required
  • QMS certification requirements
  • The SFDA's review approach and depth
  • Applicable post-market obligations (PMS Report vs PSUR frequency)
  • Application fees

The four risk classes​

ClassRisk levelTypical examples
Class ALow riskNon-sterile bandages, tongue depressors, non-measuring examination gloves
Class BLow-to-moderate riskSterile devices (Class As), measuring devices (Class Am), reusable surgical instruments (Class Ar), hypodermic needles
Class CModerate-to-high riskHaemodialysis equipment, ventilators, surgical lasers, bone fixation plates
Class DHigh riskActive implantable cardiac devices, heart valves, spinal implants, HIV diagnostic tests
Class A sub-types

Class A devices have three important sub-categories that carry higher documentation requirements:

  • Class As — Class A devices supplied in a sterile condition
  • Class Am — Class A devices with a measuring function
  • Class Ar — Class A devices that are reusable surgical instruments

These sub-types require Annex II/III equivalent conformity assessment and more detailed technical files despite remaining Class A overall.

Classification rules — aligned with EU MDR​

The SFDA's classification rules in MDS-REQ 1 are identical to the 22 classification rules of EU MDR Annex VIII. Manufacturers who have already classified their device under EU MDR can apply that classification directly to the SFDA system, using the EU-to-SFDA class mapping:

EU MDR ClassSFDA Class
Class IClass A
Class IIaClass B
Class IIbClass C
Class IIIClass D

This does not mean a CE certificate substitutes for SFDA MDMA — but it greatly simplifies the classification step.

Step-by-step classification process​

  1. Confirm the intended purpose of the device as stated by the manufacturer
  2. Determine the device type — general medical device, active device, implantable device, or IVD
  3. Apply the classification rules in MDS-REQ 1 using the correct rule set for the device type
  4. Apply the highest applicable class where multiple rules apply
  5. Document the classification justification in the technical file, referencing the specific rule(s) applied
  6. Consider any SFDA borderline guidance in MDS-G008 if the device is novel or atypical

IVD classification​

IVD devices have a separate classification system. See IVD Classification for details.

Software classification​

Software that qualifies as a medical device (SaMD) is classified using the applicable rules in MDS-REQ 1, informed by IMDRF SaMD principles. See Software & SaMD Classification.

Borderline products​

If it is unclear whether a product is a medical device, or which class applies, see Borderline & Combination Products and consult MDS-G008.

Further reading​