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  • China medical device clinical evaluation exemption catalogue is open for comments

China medical device clinical evaluation exemption catalogue is open for comments

China medical device clinical evaluation exemption
Thursday, 14 July 2022 / Published in Medical Device, News, NMPA Registration in China

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 NameClass
103-10-01Disposable intracranial pull-open fixing catheterIII
207-04-02Neuromonitor intubation of the endotracheaIII
308-07-01Medical air compressorII
410-05-04Negative pressure assisted venous drainage controllerIII
513-06-01Single/multi-part prefabricated cranioplasty plate and fastenerIII
614-06-06Negative pressure drainage blocking membraneII
714-13-02Surgical membraneIII
(drug-device combination products)
814-15-03Motorized suction of nasal dischargeII
914-15-03Nasal hemostatic catheterII
1016-06-02Contact lens care productIII
1117-05-07Temporary 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 ClassRemarks
111Sterile tubing high frequency connector   
2175Cardiac defect blocker delivery deviceHeart blocker delivery deviceIII 
3277X-ray contrast agent injection deviceContrast injection deviceIIMerge No.277 and 280
4280Contrast injection device
5345Carbon 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 08-07-04
11516Metal 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 14-02-05
16571Infusion information acquisition systemInfusion information acquisition systemII / III 
17632Medical center attraction systemMedical vacuum negative pressure unitIIMerge No.632 and 633
18633Medical gas piping systems – vacuum systems
19Other 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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