Newsletter October 2015

MEDCERT: our new website is online!

We are very pleased to present you our new website.

Under the old address you get our completely redesigned and modernized website.
Apart from the modern design, our focus for the relaunch was triggered by a so-called “responsive layout”. In a nutshell: we tried to make our website easily accessible on every device, especially mobile devices. At the same time we pursued the goal of continuously improving the usability of our website for our visitors.

We hope you enjoy our new website and look forward to receiving your feedback, wishes or criticism under:

MEDCERT at the MEDICA fair in Düsseldorf
The world largest medical devices trade show MEDICA 2015 takes place from 16 to 19 November 2015 in Düsseldrof, Germany.

You are welcome to visit us at our in hall 5 booth no. D02 – the same as previous years but in a complete new design.

Experts and lead auditors are available to discuss with you all your matters regarding certification and CE marking.

CMEF Autumn in Wuhan, China

From October 18th – 21st , 2015, the autumn CMEF 2015 in Wuhan, China, will take place.

You are invited to visit us at our booth no. B3-C09 within the German Pavilion.

Our product and certification experts will answer to all your questions.

MEDCERT-USA, LLC represented on the RAPS Annual Conference in Baltimore, USA

From 24th – 28th October, 2015 the RAPS 2015 the Regulatory Convergence, Baltimore, USA, will take place.

You are invited to visit us at our booth # 351. Our product and certification experts will be delighted to answer all your questions.

Click here for more information: RAPS – The Regulatory Convergence.

USA: Electronic Medical Device Reporting mandatory

Mandatory electronic medical device reporting (eMDR) in the US went into effect on Aug. 14, 2015. Manufacturers had got a transition period of one month where they could still send the paper report to the FDA. After this date the FDA would return to manufacturers and importers any paper submissions and companies will be required to re-submit these reports in electronic format.

The eMDR requirements apply only to manufacturers and importers; device use-facilities are encouraged, but not required, to submit MDRs electronically.
For the Electronic Submissions Gateway (ESG) please click here.

China: new guideline on technical requirements for registering medical device software

The China Food and Drug Administration (CFDA) has issued a “Guideline for Technical Review of Medical Device Software Registration” that clarifies some major issues relating to medical device software registration.

According to the CFDA, the guideline is intended to help manufacturers in submitting application documents for medical device software registration and standardize the technical review requirements for such software. Medical device software is classified as a stand-alone device or as a part of a medical device.
The guidance also includes, among others, a template for software technical data submissions.

The CFDA press release (in English): CFDA issues Guideline for Technical Review of Medical Device Software Registration.
The guideline (in Chinese): 国家食品药品监督管理总局关于发布医疗器械软件注册技术审查指导原则的通告(2015年第50号)

USA: FDA adds eight new devices to the Device 510(k) Exemptions List

The US Food and Drug Administration is exempting an additional eight medical device products from 510(k) pre-market notification requirements, adding to a list of 120 products it initially exempted.
The codes were recommended in public comments that FDA neglected to review prior to publishing its original July 1 guidance.
The FDA notice: Federal Register – Guidance for Industry and Food and Drug Administration Staff.

Ukraine's new medtech regulations finally in force

Ukraine’s new system of conformity assessment and notified bodies for medical devices came into effect on 1 July 2015. This is a year behind the original-planned entry-in-force date of July 2014.
Under already agreed transition arrangements, imports of state-registered medical devices can continue until the relevant licenses expire, by 1 July 2016 at the latest. Other transition arrangements are still not clearly set.
The new conformity assessment system includes new technical regulations related to medical devices, IVDs and active implantables.

USA: Changes to the list of the harmonized standards for medical devices

The US Food and Drug Administration (FDA) has modified its list of standards it recognizes for use in medical device premarket reviews. The changes include withdrawal, correction and revision of existing standards as well as adding 39 new entries.
According to the FDA the updated list will help manufacturers that choose to declare conformity with consensus standards to meet certain other requirements.

For the modified list please click here: FDA – Federal Register.

ATTENTION: fake certificates

We were informed about fake MEDCERT certificates. Please note that these certificates were neither issued by MEDCERT nor are valid or could be used.
For the fake certificates please click here: