Our latest “Ask us Anything” webinar this week focused on the topic of medical device submission strategies for China, specifically for devices being imported into China. Karen Cohn, Regulatory Specialist here at Rimsys was on-hand to answer everyone’s questions. Karen specializes in international submission strategies and was a subject-matter expert on NMPA submissions while at Philips.
In this article, we have included the most common questions we received and put them together with their answers, along with related links to additional information that was mentioned during the webinar.
Remember that you can always ask us a question by using #AskRimsys on Twitter or LinkedIn - or using our short survey. Your questions help us select topics for upcoming webinars, and every week we select one question to answer directly on our social media channels.
The following list provides direct links to relevant CMDE information (Center for Medical Device Evaluation of the NMPA). These sites are in Chinese, but we have found that Google translate does a good job of providing English versions for purposes of researching regulations, but be sure to obtain verified translations for documents and regulations that are important to your organization.
Karen’s answers are below.
Cantonese and Mandarin are spoken dialects of Chinese. What you are looking for is a Simplified Chinese Translation, which is the written language. There is also a written language called Traditional Chinese, but the NMPA only accepts translations into Simplified Chinese. You will also need to provide the original document as well.
The CMDE (Center for Medical Device Evaluation) has information on its standards and guiding principles (see additional links at the top of this article).
Standards for China have differences from their ISO and other standard association counterparts. There may be different labeling, testing, and other requirements. I would highly suggest that you get verified translations of these standards and review them during the developmental period of your device.
You can try to use EU GSPRs, but it is important that you do a gap analysis first and note that the EU GSPR will be using ISO and Harmonized Standards, whereas the NMPA essential principles will need to use NMPA standards. Note that the NMPA is very particular about the organization of their submission information, which includes essential principles.
The short answer is that there is a combination pathway, which is closest to the pathway available with the FDA. You are required to submit to the CMDE and the CD (Center for Drugs) and they coordinate with each other and with you. I would highly recommend having a pre-submission meeting to determine which agency should be leading the process.
It is important to align with your manager and director if you are a specialist, especially if they are not currently aware of the process of registering a device in China.
I’ve been in situations where you are working with a China counterpart - sending them detailed information and documents mainly by email and SharePoint - but you don’t get the final documentation back to review and don’t see the final submission product. The actual submission can become a bit of a black hole, which is a compliance risk. Using a tool like Rimsys can help, because it allows you to create separate submission templates such as the NMPA PTR and the NMPA eRPS ToC. You can then use these templates to easily create the submission documents. You also can clearly assign owners and track progress for each section of the submission to clearly indicate who should be doing the work.
QMS requirements have recently been updated, and the NMPA is now requiring QMS information in submission documentation. For a while, there was no guidance regarding QMS requirements, but guidance has recently been released for the inspection criteria.
Clinical evaluation requirements depend on the device type. There are a number of pathways listed on the CMDE website and your clinical team will need to understand which one is applicable to your device(s).
Building and installing a device can take 18+ months and special site requirements need to be met before clinical trials can start.
You can certainly include this information in your submission. Strongly consider sending someone from your organization with the device when it is time for type testing. It is up to the manufacturer to make sure that the type testing is done correctly, to your standard, and under conditions that are compliant with your requirements.
China requires that the device be approved/cleared in its country of origin. This doesn’t provide an abbreviated pathway.
PTR stands for Product Technical Requirements. It is a document that outlines the device specifications and testing methods based on the applicable Chinese standards. This is an important document used for the in-country testing required for registration in China and for the NMPA submission. Once approved, the NMPA testing center will stamp the PTR and send a testing summary. Both items are needed for the market access submission for Class II and III regulated products. Class I devices also need a PTR even though they do not go through type testing.
Class II and Class III Registrations expire after 5 years from their certificate approval date. The renewal must be submitted six months prior to the expiration date.
If the mandatory standards for medical devices have been revised, you may need to submit a change notification. Note that a change notification and a renewal cannot be submitted in parallel, so be conscious of the requirements and leave yourself enough time to get through the submission process.
Yes, pre-submission consultations are available through the NMPA. Ensure that you document all meetings and discussions, as it is required to include meeting notes in market-entry submissions for class II and class III devices.
You may also be interested in our Ultimate guide to the China UDI system and database.