China Med Device, LLC

02/14/2023

CMD has released its fifth edition, 2023 China NMPA Blue Book: Revised Medical Device and IVD Regulations in response to the past few years positive feedback. This all-in-one resource for medical devices and IVDs provides an up-to-date overview and information on dozens of new regulations, along with clear explanations of how they could affect registration, renewal and post-market compliance for your product in China.
Claim your FREE electronic copy of the 2023 China NMPA Blue Book today! https://chinameddevice.com/china-nmpa-bluebook-2023/

12/19/2022

China Med Device Team Wishes You a Happy Holiday!
During the holiday season, in normal and unsettling times, our thoughts turn gratefully to those who have made our progress possible. It’s been our pleasure to support your NMPA regulatory, CRO and commercialization needs in China. We hope that 2023 brings mutual success and prosperity!

09/29/2022

Check out our new webinar https://lnkd.in/eTK_JhzU on October 6.
Enhanced Requirements of Post Market Surveillance Per Order #739: Part II Labeling and IFU

In our previous Part I webinar, we gave the big picture of China PMS/GMP requirements and talked about the major updates per Order 739. Our Part II webinar will focus on Labeling and IFU, the two critical documents that must be consistent with NMPA approved certificates to comply with China post market requirements whether the devices sold in China are from overseas imports or domestically made. Violations could result in recall or products being held up at customs. More and more overseas manufacturers are having their products made in China to compete more favorably.

After the implementation of the Order 739 in June 2021, China has been increasing its surveillance on post market monitoring with more follow-on guidelines and unannounced inspections both inside and outside China. Knowing more about the newly published guidelines, and learning from the previous cases, get more insights to comply with China PMS/GMP Regulations!

Our Part II session will address the topics of:
· China NMPA definition of labels and IFU
· Relevant regulations of labels and IFU
· Best Practices for labels and IFU compliance and remediation

#739

09/06/2022

Going to the RAPS 2022 Annual Convergence September 11 – 13th in Phoenix? Visit our booth #722 to get the latest updates on NMPA (formerly CFDA)! China Med Device (CMD) is presenting and exhibiting at the upcoming RAPS Annual Conference.

Our CEO, Grace Fu Palma, will present on “Practical Implications and Changes Post Order 739 for Medical Devices and IVD in China”. Join us at this event from 9:45 – 11:00 AM MST on Tuesday, September 13 in Room W102 A-C.


To schedule a time with Grace, get more information about NMPA and advice on how to enter the Chinese market for your products, simply email us at info@ChinaMedDevice.com.

#2022

08/30/2022

We are delighted to announce the success of our webinar held on Thursday, Aug 25th. The webinar went through the national NMPA PMS key updates in QMS and GMP compliance.
Gratitude to the speakers for their presentations：
Palma, Founder and CEO - China Med Device, LLC.
Chen, Project Manager - China Med Device, LLC.

To keep up with the latest news of China NMPA regulatory affairs, please email info@chinameddevice.com or check https://lnkd.in/ghFENP24

Resources Get Updated CMD Blog Resources Library These Informative, complementary resource libraries are designed for medtech professionals to get

08/19/2022

Check out our new webinar to get more insights to comply with China PMS/GMP Regulations! Whether the devices sold in China are from overseas imports or domestically made, they must be in compliance with China GMP. After the implementation of the Order 739 in June 2021, China has been increasing its surveillance on post market monitoring with more follow-on guidelines and random inspections both inside China and outside of China.
https://lnkd.in/eBfwDUH8

08/17/2022

The NMPA reclassified 27 medical devices and modified intended use for some with an announcement on March 30, 2022. Among them, 16 devices are applied in cosmetic surgery.

08/11/2022

The NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 5, 2022, for feedback. It is an effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally accepted standard, NMPA stated in the notice.

07/28/2022

The NMPA issued the “Guideline of Drug-coated Balloon Dilatation Catheter (draft)” today on June 22, 2022, collecting public opinions.

07/26/2022

We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on positron emission/X-ray computed tomography (PET/CT system). Both technical and clinical requirements are outlined below. In the end, it is the risk and benefit analysis that got its NMPA approval.

07/20/2022

The NMPA released 55 revised or newly established medical device standards on May 18, 2022, with indications ranging from cardiovascular, plastic surgery, oncology, clinical chemistry and immunology, etc. The Standards Revisions are aimed to facilitate manufacturers with local type testing and regulatory submission and make standards more consistent with the international standards. #

The NMPA released 55 revised or newly established medical device standards on May 18, 2022, with indications ranging from cardiovascular, plastic surgery,

07/15/2022

The NMPA Medical Device Standardization Administration released the “Medical Device Classification Results for 2020-2021”. The document identifies 155 Class III, 505 Class II and 143 Class I medical devices, and 20 combination products.

The NMPA Medical Device Standardization Administration released the “Medical Device Classification Results for 2020-2021”. The document identifies 155