Freudenberg Medical registers China facility with FDA

Freudenberg Medical announced that it has registered its medical device manufacturing operation in Shenzhen, China with the FDA. “We registered our operation to manufacture a clipping device used on hospital beds,” said general manager Terry To. “Our dedicated team completed the project – from mold design to validation and mass production – in just five

NSF on path to become MDSAP Auditing Organization

NSF International’s NSF Health Sciences Certification subsidiary recently announced that it’s on the path to becoming a Medical Device Single Audit Program (MDSAP) Auditing Organization. NSF said July 11 that the MDSAP Regulatory Authority Council had accepted its application, the first of three steps for NSF Health Sciences Certification to become authorized to conduct MDSAP audits. Canada is

Medtech stories we missed this week: July 21, 2017

From Second Sight’s South Korean market entry to Sanuwave’s Indonesian distribution deal, here are medtech stories we missed this week but thought were still worth mentioning. 1. Second Sight enters South Korea market Second Sight announced in a July 5 press release that it has entered the market in South Korea with the implantation of two

Australian TGA to handle medical device advertising complaints

By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) plans to roll out “simplified and improved arrangements” for managing complaints regarding medical device and drug advertising. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those

Medical device R&D investments expected to rise through 2018

By Stewart Eisenhart, Emergo Group An Emergo survey of medical device companies finds that a higher percentage of smaller firms plan to increase their research and design spending over the next year than mid- and large-sized firms. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are

China FDA issues draft guidance on clinical evaluation of some IVD reagents

Grace Fu Palma, China Med Device China FDA recently issued a draft guidance document on clinical evaluation basic requirements for clinical exempt IVD reagents, along with a second batch of clinical exempt class II IVD reagents – 130 reagents – to the agency’s directory. Key provisions in the draft, issued May 24, deal with the

Chinese regulators starting medical device clinical trial inspection program

By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) plans to begin conducting on-site inspections of clinical trials for medical devices in an effort to improve clinical data used in premarket review decisions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the

Clinical evaluation reports and China: What you need to know

Grace Fu Palma, China Med Device China introduced new requirements for clinical evaluation reports in 2015. Understanding the China Food and Drug Administration’s new CER requirements can help companies to be better prepared in their CFDA submissions. 1. Summarizing data The CER must summarize the data from clinical literature, clinical experience, and clinical trials, etc.

How Bigfoot Biomedical wants to disrupt diabetes care

Bigfoot Biomedical is a highly competitive player in medtech’s race to develop an artificial pancreas. The 50-person company has made rapid progress towards developing a smart, automated insulin delivery system since its beginnings in 2014. Just yesterday Bigfoot announced that it is partnering with Abbott, bringing together Abbott’s FreeStyle Libre glucose monitoring tech and Bigfoot’s insulin

FDA recognizes UL 2900 cybersecurity standards

By Stewart Eisenhart, Emergo Group A set of standards published by UL to address medical device cybersecurity issues will soon be adopted by the US Food and Drug Administration to help manufacturers support security assurance claims. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the

RJG Technologies gets PAA VQ\SET recognition and ISO certification

RJG Technologies has announced that it has received ISO 9001:2015 certification and PAA\VQ-SET center recognition. The PAA\VQ-SET center recognition allows RJG to enroll people in the level 3 diploma for polymer processing operations that is part of its apprenticeship. “This center recognition will enable RJG to manage the enrollment of apprentices for the qualification that

Brazil adds Irish Standards Authority to accredited list of MDSAP auditors

By Stewart Eisenhart, Emergo Group Brazilian medical device regulators have recognized the National Standards Authority of Ireland (NSAI) as accredited to conduct quality system audits under the Medical Device Single Audit Program (MDSAP). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and

India CDSCO draft clarifies medical device, IVD registrations

By Stewart Eisenhart, Emergo Group Indian medical device market regulators have published a new draft list of medical devices that clarifies how they’ll be classified under the new Medical Device Rules 2017. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do

New Canadian medical device incident reporting rules proposals

By Stewart Eisenhart, Emergo Group Canadian healthcare market regulator Health Canada is developing new requirements for certain hospitals to report serious medical device incidents and adverse drug reactions to better protect public health. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and

CMS spikes Medicare Advantage data release at the last minute

Medicare Advantage, privately run health plans paid for by Medicare, have covered an increasing number of seniors and disabled people in recent years. More than 1/3 of the 58 million Medicare beneficiaries opt for these non-traditional plans. The government has been collecting data about the care delivered to these enrollees since 2012. Last year, it