China medical device clinical evaluation exemption catalogue is open for comments

China Medical Device Clinical Evaluation Exemption Catalogue (2022 Draft) has been released by the National Medical Products Administration (NMPA) for industry stakeholder comments. Feedback can be submitted until August 8, 2022 (see below for further information).

The draft for comments proposes to add 11 new medical device products for exemption from clinical evaluation and proposes 19 amendments to products already listed in the Catalogue of Medical Devices Exempted from Clinical Evaluation (2021), which was implemented on October 1, 2021. The 2021 Catalogue contains 1,010 medical device products, and if the 2022 draft for comments is fully implemented, a total of 1,021 medical device products will be exempted from clinical evaluation in China.

Highlights

Proposed list of latest medical devices to be exempted from clinical evaluation in China

No.Classification CodeProduct NameClass103-10-01Disposable intracranial pull-open fixing catheterIII207-04-02Neuromonitor intubation of the endotracheaIII308-07-01Medical air compressorII410-05-04Negative pressure assisted venous drainage controllerIII513-06-01Single/multi-part prefabricated cranioplasty plate and fastenerIII614-06-06Negative pressure drainage blocking membraneII714-13-02Surgical membraneIII
(drug-device combination products)814-15-03Motorized suction of nasal dischargeII914-15-03Nasal hemostatic catheterII1016-06-02Contact lens care productIII1117-05-07Temporary filling materialII

Proposed list of revisions to be made to the 2021 Catalogue of Medical Devices Exempted from Clinical Evaluation

No.No. in 2021 exemption catalogueOriginal Product NameRecommended Product NameRecommended ClassRemarks111Sterile tubing high frequency connector   2175Cardiac defect blocker delivery deviceHeart blocker delivery deviceIII 3277X-ray contrast agent injection deviceContrast injection deviceIIMerge No.277 and 2804280Contrast injection device5345Carbon dioxide monitorGas measurement equipmentII 6385Medical conductive creamMedical conductive creamII 7390Medical molecular sieve oxygen systemMedical molecular sieve oxygen systemII 8391Small molecular sieve oxygen generatorSmall molecular sieve oxygen generatorII 9434Medical air-oxygen mixerMedical gas mixerII 10437Medical air compressorMedical air compressor unitIIRevise the classification code to 08-07-0411516Metal interlocking intramedullary nailMetal interlocking intramedullary nailIII 12519Metal cables and ropesMetal cables and ropesIII 13521Non-absorbable anchor with wireNon-absorbable anchor with wireIII 14537Sternal ligationSternal ligationIII 15570Analgesic pump medicinal reservoirReservoir for portable electronic injection pumpsIIIRevise the classification code to 14-02-0516571Infusion information acquisition systemInfusion information acquisition systemII / III 17632Medical center attraction systemMedical vacuum negative pressure unitIIMerge No.632 and 63318633Medical gas piping systems - vacuum systems19Other 24 products   All GB 4234 in the exempt catalogue are amended to GB 4234.1

Implications for medical device manufacturers

Once your medical device is on the Clinical Evaluation Exemption Catalogue, you only need to provide a simplified Clinical Evaluation Report (CER) to fulfil China product registration requirements, i.e., a full CER is not required.

How to submit comments

The deadline for comments is August 8, 2022. Cisema customers may submit their feedback to their regulatory affairs project manager otherwise feedback can be sent to: huangyl@cmde.org.cn. When sending an email, please indicate "2022 Exemption Catalogue Comments" in the subject.

Further information

If you would like information on whether your medical device or IVD is exempt from clinical evaluation requirements for registration in China, please contact Cisema.

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