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  • 1.  Suspension of Importation to China by NMPA (CFDA) after Overseas Inspection

    Posted 27-Jun-2019 16:36
    Edited by Grace Fu 27-Jun-2019 16:37

    Many of you may have noticed the increasingly strict GMP requirements in China. Below is some information on NMPA (CFDA) overseas GMP inspection that I thought might be useful. I'd love to know your thoughts.

     

    In 2019, NMPA has announced 3 batches of Overseas Inspection Results. A total of 24 foreign manufacturers, including Medtronic, Becton Dickinson, Boston Scientific, B.Brown, Bausch & Lomb and Varian, were required for rectification and recall.  In addition, two manufacturers, Biocomposites and Leica Biosystems, were suspended for importation. (For RAPS article on China Overseas Inspection, please click HERE.)

    Two major issues, both resulting in suspension of importation, have been identified in the NMPA notices:

    1. Inconsistence of registration unit and sales unit

    Company: Biocomposites

    Description: Calcium sulfate and absorbable artificial bone powder are sold in the form of package, but the syringe and water for injection included in the package were not registered with NMPA.

    1. Change of Supplier without modification registration

    Company: Leica Biosystems

    Description: The supplier of raw materials, Mouse IgG and hydrogen peroxide, for the test kit manufactured by Leica Biosystems, were changed, but the supplier change has not gone through the modification registration with NMPA. 

    Other significant issues disclosed by the overseas inspections include internal packaging breakage, incomplete supplier information, improper handling of adverse events, airborne dust particles exceeding the standard, deficiencies in disinfection effect verification, raw materials mixing, testing standards mismanagement, lack of operating procedures, air filter supplier audits, etc.

    On December 28, 2018 NMPA issued the "Guideline on Overseas Inspection for Drugs and Medical Devices". This new regulation clarifies overseas inspection processes and responsibilities of NMPA and overseas manufacturers. It also specifies that overseas inspection does not only contain the manufacturing site, but also includes the overseas R&D location.


    Have you experienced NMPA overseas inspection? I'd love to listen to your thoughts. Please feel free to leave a message here or email me at gpalma@ChinaMedDevice.com,



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


  • 2.  RE: Suspension of Importation to China by NMPA (CFDA) after Overseas Inspection

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jul-2019 10:27
    This message was posted by a user wishing to remain anonymous

    ​China's regulations and enforcement are ridiculous and ever changing.  We have discontinued all sales into China.
    Original Message


  • 3.  RE: Suspension of Importation to China by NMPA (CFDA) after Overseas Inspection

    This message was posted by a user wishing to remain anonymous
    Posted 02-Jul-2019 09:38
    This message was posted by a user wishing to remain anonymous

    We have not experienced NMPA overseas inspection, as of yet. But I will write that sometimes I wonder, with all the time and effort it takes to register a medical device in China, is it even worth it. We sometimes spend 2+ years registering a device because the NMPA examiner wants to know everything, including what color shirt the engineer was wearing when running a validation. (I kid...but you get my point). China registrations are mentally exhausting.
    Original Message


  • 4.  RE: Suspension of Importation to China by NMPA (CFDA) after Overseas Inspection

    Posted 10-Jul-2019 14:42
    Dear colleagues, I can certainly understand some frustration as most of us are with our teenagers.  Before they grow to maturity, teenagers go through the phase of rapid learning and change.  NMPA (CFDA) is like the teenager whereas FDA is like the grandfather. But the change is to be more in line with the international standards and to improve the review process to introduce more quality products in China. The key is to know how to communicate with the NMPA (CFDA) reviewers given the transformation reform in the past five years with CFDA.  50% + of the reviewers were hired into CMDE in the past few years to meet the rapid growth.  You cannot simply feed them what they ask.  You need to understand the technical, clinical and regulatory background and know whether they ask makes sense.  It is the registration agency job together with the manufacture to decipher what to reply and how to reply.  If you think the question does not make sense, there are open channels to communicate with the reviewers.  Your conduit between CFDA and yourself must have the technical, clinical and regulatory understanding.  Very different knowledge base from 5 years ago.  We have done many pre-sub as well as post sub consultations to address the uncertainty or " unreasonable" questions. 

    China is the only medtech market with 20% annual growth rate for the past several years and for the future several years.  It is the 2nd largest market next to the US. There are 250 cities with population of 1 million and more.  No pain no gain.

    Please feel free to email me if you have any challenges with your China regulatory and clinical affairs.

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

    Original Message


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