Biocompatibility testing & Registration in China

[Adele]

Hi All,

We are currently going through re-registeration of a medcial device in China and have been asked to provide biocompatibility data.

No problem (or so we thought) and we supplied the biocompatibility test reports that have been used in a number of registerations around the world (including the USA).

However, the testing was done in 2000 and 2001 and the Chinese authorities haven't accepted this as the testing must be to ISO 10993-1: 2003 and the other more recent versions of the specific ISO 10993 standards.

I have tried finding out specifics of the regulation but all I can get is that it is a new regulatory requirement issued in June 2007 (but it isn't available on the English SFDA site).

Does anyone know the specifics of the regulation? Has anyone else come across this problem? How did they solve it?

Thanks!

[cyue2000]

Hi Adele,

Attached please find the Chinse version.

The new regulation says:
(1) The company can choose (a) to do all the tests based on GB/T-16886-ISO 10993, or (b) to provide a biological evaluation report to justify why some of the tests are exempted.
(2) For tests done outside China, the company should provide supporting documents on GLP qualification of the test lab.

There are two attachments, which are guidelines for biological evaluation process and the biological evaluation report.

To answer your question, I would suggest do a gap analysis first for ISO 10993:2003 and the old version, to see if additional tests are needed. If the answer is yes, then just do it (and better to do it in China). Also, I believe you should have plenty of clinical data available as you are doing re-registeration. All of the clinical data can be included in your biological evaluation report to support the safety of your device.

Best,

[harry]

Welcome Cyue2000 and thanks for that informative first post. We look forward to see your active participation.

[Adele]

Thanks cyue2000.

Is GB/T-16886-ISO 10993 based on ISO 10993-1: 2003?

We can easily write a biological evaluation report to explain the differences. However, we have the additional problem of the lab that was used not having GLP qualification. Again, this testing was done back in 2000 and 2001 and testing since that date has all been done in a GLP facility but we are left with some historical materials that were tested in a non-GLP facility.

Are we still able to meet this requirements by writing a biological evaluation report? Or does the lack of GLP certification mean we have no choice but to retest?

Thanks once again.

[liuyy]

Originally Posted by Adele

Thanks cyue2000.

Is GB/T-16886-ISO 10993 based on ISO 10993-1: 2003?

We can easily write a biological evaluation report to explain the differences. However, we have the additional problem of the lab that was used not having GLP qualification. Again, this testing was done back in 2000 and 2001 and testing since that date has all been done in a GLP facility but we are left with some historical materials that were tested in a non-GLP facility.

Are we still able to meet this requirements by writing a biological evaluation report? Or does the lack of GLP certification mean we have no choice but to retest?

Thanks once again.

The GB/T 16886.X is identical to ISO 10993-X.

[cyue2000]

Yes. GB/T 16886.1 is identical to ISO 10993.1 As a matter of fact, only ISO 10993.1 is mentioned in attament 2, not ISO 10993.1:2003. It means the current version of ISO 10993.1 is always used.

You may want to check Attachment 1, part 4 - "re-evaluation of biological safety of medical device" carefully. It says that if the manufactuer can claim that (1) to (5) in the list doesn't happen, then no re-evaluation is required for re-registration of the device. The list includes (1) change of raw materials - supplier or technical specification; (2) changes in formulation, process condition,primary package and sterilization; (3) any change happened to the final product during storage; (4) change of intended use; (5) any indication of adverse effects.