REGULATORY REFERENCES

Compliance with medical device requirements must be based upon the regulations in force that apply to these products.

Donawa Consulting is providing a selection of key regulatory references for Europe, the United States, Japan and China.

EUROPE

For Europe, we have selected the latest consolidated versions of the medical devices directives, including incorporation of the text from the major revising directive 2007/47/EC, published in the Official Journal on 21 September 2007. These are the official European Commission consolidated texts, and include the remaining original text and all the subsequent amendments in single documents.

In addition, you will find the directives reclassifying certain devices, the directive related to animal tissues used in the manufacturing of medical devices, and directives that amend the Medical Device Directive.

Finally, the Regulation covering Advanced Therapy Medicinal Products (ATMP) was published in the Official Journal on 10 December 2007.

UNITED STATES

The information provided by Donawa Consulting on this website includes some of the most important regulatory references related to medical devices in the United States.

JAPAN

Many companies are interested in marketing their products in Japan. We are providing regulatory references on Japanese requirements for quality assurance and manufacturing of medical devices and IVDs.

CHINA

For companies who wish to market their products in China, we are providing regulatory references on Chinese requirements for quality assurance and manufacturing of drugs and medical devices.