Chinese Certificate of Medical Device and IVD
keep product certifiate and PTR as unique treasure!

The example in figure 1 is for overseas or imported class II and III medical device and IVD. The meaning of approval number at approval certificate (left in figure: chinese product certficate):

1 : approval year (in this case 2016)
2 : product class (in this case 2)
3 : part of product code
4 : registration serial numberat NMPA

The PTR example summarizes the most important items. The core contents are performance specifications which are product-specific different. Normally PTR is 3-5 pages. In the fact PTR is represented as annex to NMPA certificate and its content is very similar to 510k summary.

For class I

For class I medical device there is only a filling process. At the end the filling certificate is the same as illustrated in figure 1 for class II and III medical device. The only difference is the certificate number.

Instead at third and fourth Chinese characters 注进 (approval overseas) there is 备(filling).

There are only 8 digits for filling certificate (class I MD) than 11 digits (class II and III MD)

Example

国械备20160407

After change registration

If significant changes  of products happen, the legal manufacturer has to actively submit change registration which has a bit lower registration cost and faster REAL review time by CMDE however the efforts are almost the same including un-avoidable type testing as initial registration.

Instead of new certificate, the manufacturer gets a “change notification” and PTR (revised) after product approval. On this notification, the change contents are summarized. To emphasize is that the certificate number stays unchanged. Normally the initial certificate (after renewal of the certificate, the new renewal certificate) plus all change notifications) act as a whole for presenting the current product.

What happens at renewal of certificate?

At renewal (5 years after initial registration) regarding Chinese certificate, legal manufacturer has to submit ORIGINAL initial certificate plus all change notifications and all PTRs. If the submission dossier is proved, a new certificate for another 5 year with a new certification number will be issued.

As seen in flow chart in figure 3, in the first 5 years curriculum of medical device legal manufacturers can make as many change registrations. However the life time is not extended for another 5 years as of approval date of change registration. So after initial registration, the medical device with significate changes can be extended only for another 5 years as of the date when the initial certificate is invalid. The date of initial registration or the date of renewal of the certificate is deciding and should be calculated.



When to use Chinese certificate of medical device and IVD?

After product approval in the most cases of sales activities, you need only a copy of NMPA certficate and PTR. As well for change registration in modification matter a copy of NMPA certificate and PTR are sufficient.

However, in case of change of Chinese agent (change registration in administrative matter) and of extension registration (=renewal) you have to submit the ORIGINAL Chinese certificate (change notification) AND PTR in paper.

Outlook

Having a controlled change assessment and market entry plan in China is an art. You can make a change registration of next generation of product or start initial registration. In the last case you will mark 2 different models/variants in Chinese market. Do you know that you can even add or keep 2 generations of product on the existing certificate? In this case (extension of certificate) you have one certificate with 2 models/variants of medical device.

Contact us to provide you all scenarios to have a tactic plan of next Chinese models/variants of medical device.