Quality First International

Popularity and Ease of Own-brand Labelling Created by a Confusing Lack of Regulatory Provisions Promotes Violation
Haroon Atchia from QFI writes new guidance document published by Global Regulatory Press

London, 7 June 2011

Haroon Atchia from Quality First International (QFI) has written a new 42-page guidance document entitled “Popularity and Ease of Own-brand Labelling Created by a Confusing Lack of Regulatory Provisions Promotes Violation”.

The guidance document, published by Global Regulatory Press, presents a critical examination of the regulatory environment of own-brand or private labelling with a focus on the European situation. No regulations on the own-brand labelling of medical devices exist in the European Union, which is the essence of the problem elucidated in this report.

According to the guidance document’s author, Mr Haroon Atchia, “the ever-expanding popularity of own-brand labelling as a means of acquiring exclusivity and reducing costs across numerous industries is also evident quite prodigiously in the medical device industry. For instance, the ease by which manufacturers can affix the CE mark of conformity might appear consonant with the concept of free movement of goods but actually undermines regulation, satisfactory quality, safety and performance”.

In the paper, readers will have an opportunity to consider the regulatory obligations for manufacturers, as well as a comparison of the guidance documents from NB-MED, the UK MHRA, Health Canada and the German ZLG. Considerations for own-brand labelling are highlighted, along with the advantages and disadvantages of the different approaches. Readers will then be instructed in the common documentation requirements for own-brand labelling. Finally, they will learn about the problems caused by the lack of regulation as well as some suggested improvements to the regulatory system.

The report is written in English and is supplied by email as a PDF. Price: £49.99 (plus VAT, where applicable). Purchases can be made via www.globalregulatorypress.com.

About Quality First International (QFI)

Quality First International (QFI) is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting-edge, minimally invasive and cardiovascular products and implants.

For further information, please contact:

Marija Capek, PR and Press Officer
Tel: +49 (0)176 212 444 26
Email: marija@qualityfirstint.com
Web: www.qualityfirstint.com