Timeline of review of medical device in US, EU and China

revised in 2026-11

Review by authority and notified body of medical device



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 EU, and USA. The manufacturers should be aware when they should get deficiency letter, till when they have to send deficiency reply to authority or notified body and in which time frame the marketing department should be ready to finalize labelling and advisement activities for alpha launch. The production site is subsequently the important party to produce medical device in time manner in line with product approval date.

Very often the duration of deficiency reply of medical device at manufacturers is ignored. After technical review at authority both in China and in USA and notified body under EU MDR, 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. 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 PMA in US and review of medical device with clinical trial, we just compare the timeline of typical class II medical device in EU, China and 510k in FDA..
 

Comparison of review timeline of medical device by NMPA & FDA & EU notified body 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).

Figure 2: Timeline in EU MDR

In EU is quite different due to involvement of notified body for MDR and IVDR. Besides there is routine annual inspection for MDR, IVDR and sampling review of technical documentation.

Review timeline of notified bodies under MDR/IVDR (Regulation (EU) 2026/977)”. Cover 30 days for application and contract, 120 for the QMS audit, 90 for technical documentation review, 20 for the decision, and 30/90/20 for changes. It applies from 25 February 2027, with Article 4(4) from 1 January 2028.

Similarity of medical device registration in American, European and Chinese market

Electronic technical documentation

In all countries technical documentation should be submitted in electronic form by legal manufacturer or legal representative (as US agent and Chinese agent). 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 a requested folder structure.

Two main reviews of technical dossiers at authority and .. at notified body

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.

There are no defined review rounds by notified body in EU.

Deficiency letter

After technical review either in US, in EU or in China, legal manufacturers would normally receive a deficiency letter where the deficiency was issued. 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 as well with diverse notified bodies in EU. 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.

Different medical device reviewa in American-, European- 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 EU it is not regulated and in China the time to pass the acceptance review is still unlimited.

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. There is no common time limit in EU how long manufacturer answers the deficiency letter.

Time of review of medial device registraton at US and Chinese-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. In EU for class II and III medical device it should be less than 90 days as of 2028.

Final certification of medica device

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 electronic Chinese certificate 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.

In the EU, the notified body issues a CE certificate after the final review, which under Regulation (EU) 2026/977 should happen within 20 days, and the certificate is recorded in EUDAMED. The manufacturer then issues its own EU declaration of conformity and affixes the CE mark, and the certificate is valid for a limited period (up to five years under MDR) before re-certification is needed.

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