Chinese Medical Device Regulations

Regulations for the Supervision and Administration of Medical

Manufacturers of Class I (sterile / measuring) devices IIa, IIb and III devices shall be certified with respect to the CE marking Directive 93/42/EEC by a notified body before using the CE mark and place products on the market.

To allow your organization to achieve certification on the CE, SGS is Notified Body 0120 in accordance with Directive 93/42/EEC for all devices including combination drug / medical device and associated directives 2003/32/EC (animal tissue), 2005/50/EC (total joint replacement) and 2007/47/EC (as amended). An audit of SGS successfully ensure the compliance of your products and certification 93/42/EEC.

Our global network of local offices ensures that wherever you are your business or industrial activity, certification 93/42/EC can be obtained effectively and efficiently.

The options for certification under this Directive include Annex II, V and VI include audits of the site and / or assessment of technical documentation. Our site audit usually assess compliance with both ISO 13485:2003 and with Directive 93/42/EEC.

The accreditation UKAS (United Kingdom Accreditation Service - accrediting agency of the United Kingdom) and close links with the European Commission and the competent authorities make us the natural partner to meet your needs for CE certification. The collaboration with SGS gives you access to the expertise of experts, a global network of controllers and the opportunity to combine the CE marking with our wide range of other legal certifications in a single audit.

CE marking and ability to sell your medical devices in Europe with 93/42/EEC certification of SGS UK.

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China Medical Science and Technology Press Technical basis of medical device regulation(Chinese Edition)
Book (China Medical Science and Technology Press)
2013-03-20 12:19:34 by flaveur

"Obamacare" ..jobs destroyed in NY, WI, MA, etc.

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

2013-03-20 12:20:55 by flaveur

Um, it's actual closings and layoffs. Hello?

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

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