Is it legal for manufacturers to cope with issues of initial registration without an agent ?
Unfortunately, it is NOT legal unless the manufacturers have branches with qualification in China to deal with the registration issues. Otherwise, it is a must-do that manufacturers overseas are required to appoint a Chinese agent for the medical device registration.
How long is the NMPA review process for the initial registration of the medical device ?
After the registration materials are accepted by NMPA, technical review for Class II medical devices takes 60 working days to process while for Class III medical devices, technical review takes 90 working days. If supplementary materials are required by NMPA, manufacturers are obliged to conduct submission within one year, otherwise the review may result in termination.
In terms of the initial registration for market entry of mainland China, what is the registration fee needed ?
Regarding the registration fee for NMPA, as for the imported medical devices, the registration of Class II medical device needs 210,900 CNY while that of Class III costs 308,800 CNY. In addition, other kinds of possible fees should be taken into consideration such as fees of document translation, clinical trial, and so forth.
Is it possible for a medical device with CE or FDA certificate to enter SAR (HK/MO) and pilot area such as Hainan and the Greater Bay Area ?
MDs with CE or FDA certificate are feasible to enter SAR without NMPA certificate. As for the Greater Bay Area and Hainan province, MDs marketed in HK or MO as a premise can enter the pilot areas if designated medical institutions in pilot areas are willing to procure medical devices out of clinical urgent needs under the approval of local government.