Global Medical Device Regulation: Emphasis on Active Implants

ISBN-13: 9783659445736 / Angielski / Miękka / 2013 / 144 str.

Patel Keyur N.

Opis

Regulations for medical devices in EU Member countries are governed by European Medicine Evaluation Authority, popularly known as EMEA. As per EMEAs guideline each member country has to strictly follow the common guidelines with exception to rules and regulation that are modified by state authorities but must be in conformity with EMEA Guideline. Regulations posed in here are further divided in implantable and active implantable medical devices thereafter where manufacturing, testing and distribution can only be done once it is CE marked. In case of non CE marked devices i.e. non-EU member manufacturer, market authorisation process shall be completed prior to approval and separately. For brazil market that is governed by ANVISA, medical devices are classified into four different classes. There is no independent discrimination made for Active implantable medical devices but most non invasive devices are covered in Class I. While those which are to be connected with blood storage and other devices are classified into class II. Class III devices are those which are connected or included with wounds or healthy tissues.

O autorze

Keyur N. Patel (M.Pharm)and Kandarp N. Trivedi(M.Pharm) is a Post Graduate Student at Faculty of Phamacy, Shri Satsangi Saket Dham Ram Ashram Group of Institutes, Vadasma. Dr.Bhuvan P. Raval, M.Pharm, PGDPRA, MBA, FSAB, FICPHS, D. Lit is an Asst. Professor at Faculty of Phamacy, Shri Satsangi Saket Dham Ram Ashram Group of Institutes, Vadasma.