中国国际医疗器械设计与制造技术展览会(Medtec China)2018

Dedicated to design & manufacturing for medical device

25-27 September 2019 | Shanghai,China

Policies & Regulations

2019.08.21
Avoid These Headaches During Regulatory Submissions
Here are some tips on how to avoid deficiencies during final submissions, particularly those involving biocompatibility data.



Read More

2019.08.01
New Approval Helps Implanting Propel Mini a Little Bit Easier
The Menlo Park, CA-based company said it has received a nod from FDA for the Straight Delivery System for use to place its Propel Mini Steroid implant.



Read More

2019.07.30
Medtronic Looks to Expand Reach of Artificial Pancreas with New Submission
The Dublin-based company filed a PMA submission to FDA requesting for non-adjunctive labeling for the Guardian Sensor 3, as part of the MiniMed 670G system.



Read More

2019.07.19
The deadline for ISO 13485:2016 certification is . . . now!
Are your critical suppliers in compliance?



Read More

2019.04.19
FDA Flips the Switch on Pelvic Mesh Manufacturers
FDA has ordered Boston Scientific and Coloplast to stop selling surgical mesh intended for transvaginal repair of pelvic organ prolapse. Patient advocates say the action was not made soon enough and does not go far enough, but it is a step in the right direction.

Read More

2019.04.18
Dirty Scopes Are Still a Big Problem
FDA-mandated studies indicate higher than expected levels of contamination on duodenoscopes after reprocessing.



Read More

2019.03.26
Taking a Deeper Look at Device Certification and Recertification
Experts discuss how to prioritize medical and IVD devices under the new MDR/IVDR in Europe.



Read More

2019.03.22
Key Medical Packaging Standard, ISO 11607-1/2 Published; More Regulatory Support on the Way
With the EU Medical Device Regulations just over one year away, this latest revision aims to help medical device manufacturers meet the regulation’s General Safety and Performance Requirements.



Read More

2019.03.14
SO 80369: Frequently Asked Questions, Answered
Here are answers to some common questions about developing and testing small-bore connectors.



Read More

2019.02.25
8 Things You Should Know about the EU MDRs
Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared?



阅读更多

Page 1 of 4 (35): 1 2 3 4