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 Code | Product Name | Class |
|---|---|---|---|
| 1 | 03-10-01 | Disposable intracranial pull-open fixing catheter | III |
| 2 | 07-04-02 | Neuromonitor intubation of the endotrachea | III |
| 3 | 08-07-01 | Medical air compressor | II |
| 4 | 10-05-04 | Negative pressure assisted venous drainage controller | III |
| 5 | 13-06-01 | Single/multi-part prefabricated cranioplasty plate and fastener | III |
| 6 | 14-06-06 | Negative pressure drainage blocking membrane | II |
| 7 | 14-13-02 | Surgical membrane | III (drug-device combination products) |
| 8 | 14-15-03 | Motorized suction of nasal discharge | II |
| 9 | 14-15-03 | Nasal hemostatic catheter | II |
| 10 | 16-06-02 | Contact lens care product | III |
| 11 | 17-05-07 | Temporary filling material | II |
Proposed list of revisions to be made to the 2021 Catalogue of Medical Devices Exempted from Clinical Evaluation
| No. | No. in 2021 exemption catalogue | Original Product Name | Recommended Product Name | Recommended Class | Remarks |
|---|---|---|---|---|---|
| 1 | 11 | Sterile tubing high frequency connector | |||
| 2 | 175 | Cardiac defect blocker delivery device | Heart blocker delivery device | III | |
| 3 | 277 | X-ray contrast agent injection device | Contrast injection device | II | Merge No.277 and 280 |
| 4 | 280 | Contrast injection device | |||
| 5 | 345 | Carbon dioxide monitor | Gas measurement equipment | II | |
| 6 | 385 | Medical conductive cream | Medical conductive cream | II | |
| 7 | 390 | Medical molecular sieve oxygen system | Medical molecular sieve oxygen system | II | |
| 8 | 391 | Small molecular sieve oxygen generator | Small molecular sieve oxygen generator | II | |
| 9 | 434 | Medical air-oxygen mixer | Medical gas mixer | II | |
| 10 | 437 | Medical air compressor | Medical air compressor unit | II | Revise the classification code to 08-07-04 |
| 11 | 516 | Metal interlocking intramedullary nail | Metal interlocking intramedullary nail | III | |
| 12 | 519 | Metal cables and ropes | Metal cables and ropes | III | |
| 13 | 521 | Non-absorbable anchor with wire | Non-absorbable anchor with wire | III | |
| 14 | 537 | Sternal ligation | Sternal ligation | III | |
| 15 | 570 | Analgesic pump medicinal reservoir | Reservoir for portable electronic injection pumps | III | Revise the classification code to 14-02-05 |
| 16 | 571 | Infusion information acquisition system | Infusion information acquisition system | II / III | |
| 17 | 632 | Medical center attraction system | Medical vacuum negative pressure unit | II | Merge No.632 and 633 |
| 18 | 633 | Medical gas piping systems – vacuum systems | |||
| 19 | Other 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.
