Regulatory Open Forum

Dear colleagues,

I came across an article that some Chinese manufacturers aim to submit their MD in countries that recognize NMPA marketing approval. I don't recall any country that accepts NMPA approval as a predicate approval. Please educate me on this :)

My other question is regarding CE marking recognition outside of the EU - what are the countries that 1) require a predicate approval, AND 2) accept CE Mark as that predicate approval?

I deeply appreciate your valuable insights into this topic.

Thanks,
Jo

------------------------------
Jo Huang RAC
Assoc Manager - Regulatory Affairs
Irvine CA
United States
------------------------------

For Chinese MD manufacturers going out of China, usually their first stop is EU and Latin America and some to US.  Approval is necessary.  For none-Chinese manufacturers who want to go to China, you need COO (country of original approval) and your CE marking and legal manufacturer needs to be consistent from EU.  Not sure what you mean with predicate approval in this context.  For China, in order to be qualified as predicates, the predicate devices must be approved by NMPA already.  HK does accept CE marking but to get into public hospitals, you will have to do the filing and special approval.  

------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
------------------------------

Original Message:
Sent: 17-Feb-2022 17:31
From: Jo Huang
Subject: NMPA approval as a predicate approval for MD vs CE marking as predicates

Dear colleagues,

I came across an article that some Chinese manufacturers aim to submit their MD in countries that recognize NMPA marketing approval. I don't recall any country that accepts NMPA approval as a predicate approval. Please educate me on this :)

My other question is regarding CE marking recognition outside of the EU - what are the countries that 1) require a predicate approval, AND 2) accept CE Mark as that predicate approval?

I deeply appreciate your valuable insights into this topic.

Thanks,
Jo

------------------------------
Jo Huang RAC
Assoc Manager - Regulatory Affairs
Irvine CA
United States
------------------------------

Thank you so much, Grace, for adding more context! Deeply appreciate it :)

------------------------------
Jo Huang RAC
Assoc Manager - Regulatory Affairs
Irvine CA
United States
------------------------------

Original Message:
Sent: 18-Feb-2022 09:48
From: Grace Fu Palma
Subject: NMPA approval as a predicate approval for MD vs CE marking as predicates

For Chinese MD manufacturers going out of China, usually their first stop is EU and Latin America and some to US.  Approval is necessary.  For none-Chinese manufacturers who want to go to China, you need COO (country of original approval) and your CE marking and legal manufacturer needs to be consistent from EU.  Not sure what you mean with predicate approval in this context.  For China, in order to be qualified as predicates, the predicate devices must be approved by NMPA already.  HK does accept CE marking but to get into public hospitals, you will have to do the filing and special approval.  

------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com

Original Message:
Sent: 17-Feb-2022 17:31
From: Jo Huang
Subject: NMPA approval as a predicate approval for MD vs CE marking as predicates

Dear colleagues,

I came across an article that some Chinese manufacturers aim to submit their MD in countries that recognize NMPA marketing approval. I don't recall any country that accepts NMPA approval as a predicate approval. Please educate me on this :)

My other question is regarding CE marking recognition outside of the EU - what are the countries that 1) require a predicate approval, AND 2) accept CE Mark as that predicate approval?

I deeply appreciate your valuable insights into this topic.

Thanks,
Jo

------------------------------
Jo Huang RAC
Assoc Manager - Regulatory Affairs
Irvine CA
United States
------------------------------