17-18 February THE 3RD ANNUAL AFRICA HEALTHCARE SUMMIT 2016

Due to the increase of GDP in several Countries, it is not surprising to find out that government Healthcare spending rank #2 in Africa. The Healthcare sector is forecast to grow tremendously years ahead, creating exiting opportunity for the medical industry!

Like us, if you are interested in the latest Healthcare developments, where are the challenges and investment opportunities across the continent and finally what to expect as reforms, this summit is the best place to find out!

Would you like to discover more about Medical Device distribution in Africa? Just connect with us and our representatives at the summit will be happy to meet you there and discuss this exciting dynamic of the African market!

www.africahealthcaresummit.com

11-13 March 2016 – MEDICAL FAIR INDIA 2016

The healthcare sector is predominant in the Indian economy, not surprising that it is one of the leading market for a majority of medical device manufacturers.

Take advantage of meeting on site with one of our representatives, either you are a visitor or manufacturer, we want to know about you! Click here to schedule a meeting

Official website of Medical Fair India 2015

www.medicalfair-india.com

(SAARC) The South Asian Association for Regional Cooperation.

Transition Plan for the Medical Device Single Audit Program (MDSAP)

Background

The Medical Device Single Audit Program (MDSAP) was initiated at the International Medical Devices Regulators Forum’s (IMDRF) inaugural meeting in Singapore in 2012.

The program was designed and developed so that a single audit, performed by an authorized Auditing Organization (AO), meets the quality management system (QMS) requirements of multiple regulatory agencies, derived from the International Organization for Standardization (ISO) 13485:2003. Employing a single audit program allows regulatory agencies to efficiently leverage resources, reduce regulatory burden on industry without compromising public health, and promote more aligned and consistent technical requirements, among other benefits. In addition to Health Canada, the participating agencies are the Australian Therapeutic Goods Administration (TGA), the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA), the Japanese Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and the United States Food and Drug Administration (FDA).

Transition Plan

The Pilot is scheduled to conclude December 31, 2016, and as stated in Health Canada Notices dated January 2014 and January 16, 2015, Health Canada intends to implement MDSAP as the sole mechanism for manufacturers to demonstrate compliance with the quality management system requirements of the Medical Devices Regulations (the Regulations). MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. This implementation will begin at the conclusion of the Pilot on January 1, 2017, and will span a period of two years. During this two years’ period, Health Canada will accept certificates issued under both CMDCAS and MDSAP. As of January 1, 2019, only MDSAP certificates will be accepted. Further details will be released as the transition plan is finalized. Health Canada’s transition to MDSAP is an attempt to align with the transition period for the revised version of ISO 13485, which is anticipated to be published in early 2016.

 

Publication of Medical Device Inspection Information

The database will consist of three main elements.

1. Lists of Inspections. The database will include general information (name, date, rating) on all medical device inspections since January 1, 2012 to present.

2. Initial Inspection Deficiencies provide a preliminary overview of the inspection findings and are published within 3 days of the inspection.

3. Inspection Report Cards offer plain language summaries of inspections and they are published within 30 days of the inspection. The Report Cards will include a detailed information such as information identifying the establishment, date of the inspection, inspection type and rating, etc.

For an up to date listing of medical device establishment licenses, or further information about Health Canada’s Regulatory Transparency and Openness Framework can be found on Health Canada’s website.