In accordance with the Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 680 in 2017): the State classifies and regulates medical devices on the basis of level of risk.
Class I medical devices are those at low level of risk, and their safety and effectiveness can be ensured through routine regulation. Class I medical devices shall be regulated through recording: 1) For a domestic Class I medical device, the domestic manufacturer shall submit recording application dossiers to the Medical Products Administration authority at the level of city with sub-districts where the manufacturer is located; 2) For an imported Class I medical device, the overseas manufacturer shall entrust an Agent in China to submit the recording application dossiers to NMPA.
Class II medical devices are those at middle level of risk, and strict regulation is required to ensure their safety and effectiveness. Class II medical devices shall be regulated through registration: 1) For a domestic Class II medical device, the domestic manufacturer shall submit registration application dossiers to the Medical Products Administration authority at the level of province, autonomous region or municipality where the manufacturer is located; 2) For an imported Class II medical device, the overseas manufacturer shall entrust an Agent in China to submit the registration application dossiers to NMPA.
Class III medical devices are those at high level of risk, and strict regulation with special measures are required to ensure their safety and effectiveness. Class III medical devices shall be regulated through registration: 1) For a domestic Class III medical device, the domestic manufacturer shall submit registration application dossiers to NMPA; 2) For an imported Class III medical device, the overseas manufacturer shall entrust an Agent in China to submit the registration application dossiers to NMPA.
Official Administrative Charges
| Imported Class III | CNY 308,800.00 |
Project Establishment
Budget, contract, cooling-off period (1 month)
Preparation of Application Dossiers before NMPA Acceptance
Product test (vary from product to product, 6 months on average)
Clinical trials cannot be carried out in parallel with product tests, and the time needed for clinical trials should be calculated separately (estimated: at least 12 months).
Please contact OSMUNDA if you need a more rigorous calculation. (Except for the products covered by the Catalogue of Medical Devices Exempted from Clinical Trials)
The preparation of registration application dossiers can be carried out in parallel with product tests or clinical trials.
After NMPA Acceptance
The time consumed by NMPA according to law: 10 months (188 working days, 20 working days per month, excluding holidays)
Time limit for the preparation of supplementary dossiers: 0~12 months, depending on the completeness of application dossiers submitted. (6 months on average)
QMS audit: based on the current laws and regulations, it is possible that NMPA carries out QMS audit at the site of the overseas manufacturer.
Total Time Budget
Initial registration of imported Class III MD (without clinical trials) (estimated: at least 17～23 months)
Initial registration of imported Class III MD (with clinical trials) (estimated: at least 35 months, among which, clinical trials accounts for 12 months)
Initial Registration of Imported Class III MD
Registration Renewal of Imported Class III MD
Initial Registration of Imported Class II MD
Registration Renewal of Imported Class II MD
Application for Innovative Medical Device (Imported)
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Osmunda