NMPA registered device VS country of origin (free sales certificate)

[Azhar Anwar]

Hi folks,
I have a case for which I need help from experienced people:

There is an IVD product which is self-certified under the IVDD (other, general type of IVDS) in EU. And it is classified as Class C under the IVDR and therefore having a grace period till 26 May 2026.

The product is currently being registered in China as Imported Class 3 IVD device.

Scenario: Expecting the product obtains registration certificate (will be 5 years valid) in China (NMPA clearance) before the transition deadline 26 May 2026. After this date the country of origin (free sales certificate) will no longer be available (No more CE-marking under the IVDD).

Question: Can the product continue to be marketed in China for 5 years, irrespective of the loss of the CE-Mark in Country of Origin (EU)?

Thanks in advance

 

[gavin0209]

the product can be saled in china。

 

[Azhar Anwar]

the product can be saled in china。

Thanks Gavin, but could you provide any source?

 

[gavin0209]

You may refer to Article 79 of 《 Administrative Measures for Registration and Filing of medical devices》，below is Chinese information。
Article 79 The registrant shall take the initiative to conduct post-marketing research on the medical devices, further confirm the safety, effectiveness and quality control of the medical devices, and strengthen the continuous management of the medical devices already on the market.



Where the design, raw materials, production technology, scope of application and method of use of the second and third class medical devices have been substantially changed, which may affect the safety and effectiveness of the medical devices, the registrant shall apply to the original registration department for registration alteration procedures; Any other change shall be filed with the original registration department within 30 days from the date of the change.


第七十九条注册人应当主动开展医疗器械上市后研究，对医疗器械的安全性、有效性和质量可控性进行进一步确认，加强对已上市医疗器械的持续管理。
已注册的第二类、第三类医疗器械产品，其设计、原材料、生产工艺、适用范围、使用方法等发生实质性变化，有可能影响该医疗器械安全、有效的，注册人应当向原注册部门申请办理变更注册手续；发生其他变化的，应当在变化之日起30日内向原注册部门备案。

 

[Azhar Anwar]

You may refer to Article 79 of 《 Administrative Measures for Registration and Filing of medical devices》，below is Chinese information。
Article 79 The registrant shall take the initiative to conduct post-marketing research on the medical devices, further confirm the safety, effectiveness and quality control of the medical devices, and strengthen the continuous management of the medical devices already on the market.



Where the design, raw materials, production technology, scope of application and method of use of the second and third class medical devices have been substantially changed, which may affect the safety and effectiveness of the medical devices, the registrant shall apply to the original registration department for registration alteration procedures; Any other change shall be filed with the original registration department within 30 days from the date of the change.


第七十九条注册人应当主动开展医疗器械上市后研究，对医疗器械的安全性、有效性和质量可控性进行进一步确认，加强对已上市医疗器械的持续管理。
已注册的第二类、第三类医疗器械产品，其设计、原材料、生产工艺、适用范围、使用方法等发生实质性变化，有可能影响该医疗器械安全、有效的，注册人应当向原注册部门申请办理变更注册手续；发生其他变化的，应当在变化之日起30日内向原注册部门备案。

Thanks Gavin, this is very helpful.

 

[Franky Zhang123]

Hi folks,
I have a case for which I need help from experienced people:

There is an IVD product which is self-certified under the IVDD (other, general type of IVDS) in EU. And it is classified as Class C under the IVDR and therefore having a grace period till 26 May 2026.

The product is currently being registered in China as Imported Class 3 IVD device.

Scenario: Expecting the product obtains registration certificate (will be 5 years valid) in China (NMPA clearance) before the transition deadline 26 May 2026. After this date the country of origin (free sales certificate) will no longer be available (No more CE-marking under the IVDD).

Question: Can the product continue to be marketed in China for 5 years, irrespective of the loss of the CE-Mark in Country of Origin (EU)?

Thanks in advance

The product can be marketed in China for 5 years.