Change registration in China

At job interview of regulatory affairs manager, if the main task is asked, the answers are 80% to maintain product change. It means change assessment with own change procedure and notify change in respective markets. There are many good example markets as US, Canada and Singapore with clear guidance of significant change.

However in China it is opposite to transparent.



In this article you will learn that manufacturers do NOT need to passively notify all unnecessary changes but bundle limited significant change together in one registration.

When is change registration essential in China?

Product changes (or modification) are happening in the whole lifecycle of medical device.

*Does authority have to prove all product changes? *

NO.

Significant change matters. We explain it in Chinese markets.

In other article we listed the typical significant change in brief mentioned Chinese regulations:

• product name
• model
• specification
• structure and composition
• scope of application
• technical requirements of the product
• address of the manufacturer of the imported medical device

Besides there is administrative change for

• name and residence of legal manufacturer
• name and residence of chinese agent

For IFU change, there is a single application where the revision difference in details should be listed.

From our best practise the following must be considered as significant too:

• Critical specification in product technical requirement
• Critical content in Chinese certificate
• Critical change at applicable chapter in Chinese obligatory standards

Which technical documentation (TD) is needed?

Depending on the number of significant changes, the technical documentation of change registration must reflect the included product change.

Here are mostly submitted "abbreviated TDs" than initial registration besides administrative documents:

• General explanation of product changes
• Non clinical studies (Supportive testing of respective changes)
• New assessment of V&V due to respective changes plus testing report
• Device description (very often)
• (Whole) risk management (marking risk analysis of respective changes marked)
• IFU
• Software file (if applicable)
• Type testing and PTR  (if applicable)

Please pay attention whether significant changes impact PTR. If yes, the whole or part of PTR will through type testing verified which takes A LOT times.

What doses final Chinese certificate looks at?

There is only a certification notification with same certification number where the changes are summarised. For next renewal original certification with change notification must be submitted.

Even a change registration is approved. The validity of Chinese certificate is related to original certification for 5 years.

Example:

• Initial registration: 2020-06-05
• Change registration I in 2022
• Change registration 3 in 2023
• Renewal should be till 2025-06-05, which is suggested 6 months beforehand to start.

Time and cost

Let us have a full analysis of time and cost which is not always transparent depending on Chinese legal representative.

*Regarding the review time for change registration it is highly related to complex of products changes. It could be as long as initial registration. Actually the reply time by manufacturer is mostly not calculable long “war” which in many manufacturers longer than review time at Chinese authority.

**If local testing is essential, it is also difficult to predict a general time and cost. Normally the duration of testing is shorter. Considering of examination of PTR, troubleshooting till final report at testing, the effort of initial registration and change registration is equivalent similar.

Regulatory intelligence of product change

For the experienced manufacturer of medical device, the change registration is harder than initial registration. After telling the product changes to authority, there are deep digging questions from authority.

It makes sense to have a gap analysis of changes. We have some change intelligent thoughts for smart manufacture:

• Does it make sense to have a second initial registration to have 2 product models in Chinese markets?
• Wenn there will be change A in 2026, change B in 2027, is it not clever to bundle these 2 changes in one registration and submit in 2027?
• Wenn more than 5 significant changes are to include is it possible to split not necessary changes to next generation.
• Wenn change registration bears unique product features, why not to have sound new marketing name (in China model name)?