Time and Cost

Session 1.6 Time and cost to register medical device in China

Extensive, however worthy it!

How long and how much does registration process of medical device in China take?

To plan market access of medical device in China, it is indispensble to calculate the cost and time in prior to project start. We list the official cost of product registration at NMPA and the average time to get product approved below in the table.

Product Class	Type	Official cost (EUR)	Time (from preparation)
Class I	Initial and change registration	Free	1 month
Class II	Initial registration	26.500	16-24 months
	Change registration	5.300	16-24 months
	Extension registration (every 5 years)	5.150	5 months
Class III	Initial registration	38.900	24-36 months
	Change registration	6.350	24-36 months
	Extension registration (every 5 years)	5.150	7 months
	Pre-Sub	Free	1 month
	Application of Product Classification	Free	3 months
IFU	change registration	Free	1 month

How is timeline of review of NMPA?

In Figure 1 we outline the timeline of review process at NMPA. The time at review process applies to all three types of product registration except change registration in administration matter which need 35 weekdays. All time shown in Day is related to weekday at authority site on the left site of figure, besides the preparation time of additional request 1 year at legal manufacturers site on the right of figure. The technical dossier can be submitted through electronic regulated product submission eRPS. All notification letters from NMPA and additional response from manufacturers are communicated per eRPS.

After the first 5 weekdays after submitting electronic technical dossiers, NMPA provides an acceptance review with known check list. If the dossiers were complete, a letter will be notified to legal manufacturer to finalize payment of product registration. If NMPA sent you a notification letter, it means often deficiencies in term of completeness of dossiers, at the moment even in technical issure. This acceptance review was new since 2019.

There are two stages of technical reviews (as US substantive review) respectively with 60 weekdays for class II MD and 90 weekdays for class III MD. The second technical review can be called review of deficiency reply or 60-Day-Supplement (60 weekdays = 3 months). Between these 2 technical reviews, legal manufacturer has ONE YEAR time to submit the additional response. The clock holds for responding the additional request at NMPA site. The review time at NMPA for class II MD is around 8 months (155 weekdays) and for class III MD 9 months (185 weekdays).

Timeline of technical review of dossiers at CMDE

So please find strategy as soon as possible after you get the additional request. Translate the request in Chinese firstly in plain language so that everybody related to response at company can follow it. Delegate the task to appropriate department to answer with deadline . At the end the response must be in Chinese transferred to reviewer. The time flies despite of 1 year time to answer.

Please be aware of time consuming testing before submission hopefully rarely after deficiency on the site of manufacturers.

Have a check of local Chinese testing or outsourced testing.

Have a controlled project management considering working tie at all parties and report this at your management review:)

Example: official real review -, reply - and toal time at registration

from official authority site (stand: March, 2021)

statistical review time at CMDE for medical device in China

The table from China's authority Center for Medical Device Evaluation (CMDE) is extrem informative. The third column corresponds to real review time after 2. stage technical review from CMDE. The time in fifth columne ("average time of deficency responce in table) is working time of deficiency letter at site of legal manufacturers.

In general the review time for initial registration is way longer than change registration (change of permits in table). It is surprising that CMDE for both types of registration needs fewer days (third column in figure 2) than due time (see figure 1). Manufacturers should be ready to get deficiency letter quite earlier. It is to imagine that manufacturers need really long (10 months for initial - and 4,5 months for change registration) to answer the deficiency letter. The real total time for registering new class II and III medical device is almost the same as around 15 months (299 days and 305 days).

When the class II and III medical device is once registered at NMPA, the technical review time of medical device at renewal can be quite smooth, in average 4 months.