Timeline of dossier review at FDA und NMPA

In general

The regulatory intelligence is most talked topic at pre-market registration process for all manufacturers of medical device. We hereby highlight the valuable timeline of medical device at authority in the most important market China and USA. The manufacturers should be aware when they should get deficiency letter, till when they have to send deficiency reply to authority and in which time frame the marketing department should be ready to finalilize labelling and advisement activities. The production site is subsequently the important party to produce medical device in time manner in line with product approval date.

Very often is the time period of deficiency reply at manufacturers ignored. After technical review at authority both in China and in USA, manufacturers have only limited time to address deficiency letter. The R&D group and Co. should play a great role at this final spurt to contribute to hopefully last technical reply to review. The project management with precise resource plan during the technical review is as thrillingly important as extensive preparation of submission dossier.

Due to complex registration process of many class III medical devices in China and PMA in US, at which

clinical trial is often essential, we just compare the timelne of typical class II medical device in China and 510k in FDA.
 

Comparison of review timeline of medical device at NMPA & FDA and deficiency reply at manufacturers 

At figure 1 we show two similar timelines of review at authority at FDA in USA und at NMPA in China. At each right site of workflow the reply time is addressed to manufactures, at each left site the (due) time is needed at authority. The time shown at FDA is calendar days and the time shown at NMPA is weekdays (20 weekdays = 1 month).

2. Similarity of medical device registration in American and Chinese market

Electronic dossiers

In both countries the technical dossiers have to be submitted in electronic form by legal representative (US- and Chinese agent) in country. In US the dossier is in term of eCopy as the whole. In China there is a system called Electronic regulated product submission (eRPS) where e.g. Chinese agent uploads the technical dossier in arequested folder structure.

Two main reviews of technical dossiers at authority

In both markets at FDA and at NMPA, the authority executes firstly acceptance review at which the completeness of technical dossiers is controlled, followed by technical or substantial review at which the technical sections in dossier are proved in details. At the stage of acceptance review both authorities use a kind of checklist. At FDA it is called "refuse to accept policy for 510k", at which the acceptance checklist can be filled by manufacturers and submitted.

Deficiency letter

After technical review either in US or in China, legal manufacturers would normally receive a deficiency letter where the deficiency was listed. During the preparation of deficiency at site of legal manufacturer the clock stops at both authorities in term of review time.

Consulting prior to submission and after deficiency letter

It exists pre-submission meeting with American - and Chinese authority prior to submission. The quality of pre-submission in US is undoubtedly more qualitative and organised than a brief Chinese "consulting meeting" with authority. Nevertheless, after deficiency letter in China, manufacturers can either have a face to face consulting or by telephone or consult per printed form to address exactly deficiency.

2. Difference medical device registration in American and Chinese market

Time to answer the authority

1. To address acceptance failure at sites of manufacturers, there are 180 calendar days limit in US. In contrast, in China the time to pass the acceptance review is still unlimited. Due to eRPS system in developing stage it is hoped that authority would give one day limited time for manufacturers to complete dossiers.

2. To address the deficiency letter it is a bit different. For 510k, it is called additional information for which manufacturers have only 180 calendar days to prepare answer. In China, manufacturers have one year time to fix the deficiency.

Due - and real time of review of medial device registraton at US and CH-authority

As in figure 1 illustrated, in theory FDA needs 100 calendar days till final approval of 510k compared to 155 weekdays (around 236 calendar day) of class II medical device at NMPA. The approval time in China is obviously 2.5 times longer than it in US. 

Final certification

FDA makes a MDUFA decision at its decision letter that either substantially equivalent (SE) or not substantially equivalent (NSE) will be granted, if SE, there is a 510k number. In China, manufacturers get a real Chinese certification in paper where the certification number, info of manufacturers and Chinese agent is stated. Very important is besides certification also Product Technical Requirement (PTR) issued where technical parameters, testing methods, applied standards, important annexes are written.

Contact us to overcome regulatory hurdle in China to have record time till approval.