China Medical devices Class

Medical Device autoclave Class N - Buy Medical Device

Market approval


Europe - CE marking

TÜV SÜD is a Notified Body identification number (0123) of the European Union and may conformity assessment according to EU directives perform that are, which is mandatory for all products imported into the EU. We audit quality management systems, test your technical documentation (design dossier) and test and verify your products according to appropriate guidelines 93/42/EEC (MDD), 90/385/EEC (AIMD) and 98/79/EC (IVDD).

USA - FDA 510 (k)

TÜV SÜD is certified by the FDA as part of the 'Accredited Persons FDA 510 (k) Third Party Review Program' as an independent body. We must review the documentation produced as part of the 510 (k) submission and review. This program was initiated by the FDA to allow manufacturers of medical products faster and more efficient market access.

As part of the FDA's Accredited Persons Inspection Program TÜV SÜD is accredited to carry out inspections instead of FDA by manufacturers of medical devices.

In addition we can also offer so-called mock inspections, give a statement as to whether your quality management system complies with the requirements of the FDA.

Canada - CMDCAS

Manufacturers of medical devices of classes II, III and IV and in-vitro diagnostics who want to sell their products on the Canadian market must have their quality management system of a CMDCAS (Canadian Medical Devices Conformity Assessment System)-accredited certification body.

  • TÜV SÜD has been accredited as the first certification body (registrar) from the Standards Council of Canada (SCC) for the implementation of CMDCAS certification to ISO 13485. The certification can be done simultaneously with the audits according to ISO 13485.
  • TÜV SÜD is also accredited by the SCC as a National Recognized Testing Laboratory (NRTL), and thus may Tests for electrical safety according to CSA C22.2. 60601-1 perform.

Japan - PAL & JGMP

Foreign manufacturers who want to sell their foreign-made medical devices in Japan, first need a business license. With certification from TÜV SÜD you can prove that your products meet the requirements of the J-PAL and this so qualify for the launch in Japan.

Ava the Elephant Ava the Elephant Talking Children's Medicine Dispenser
Baby Product (Ava the Elephant)
  • Included dropper is filled with the desired medicine, Protected by a US patent with an additional patent pending, Registered by the FDA as a class 1 medical device...
2007-06-02 02:00:35 by DaveCal

Investing in China through non-Chinese companies

I am wondering what is the best way to invest in China, India and all of these emerging countries through regular multinationals.
For example, in 10-20 years, a large percentage of these people will move out of poverty and will be middle class. What are they going to buy and in what order? What will they want first?
My guess is:
Good healthcare
Cars, motorbikes
Fast food
Household chemicals, cleaners etc
Nothing surprising here. But I figure there should be lots of growth for just run on the mill multinationals like Colgate Palmolive, Coke, Pepsi, AIG , Bank of America

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