S'inscrire   |   Nous joindre   |   Imprimer la page   |   Se connecter
Rendement du Bureau des matériels médicaux (BMM) de Santé Canada
Assurer de meilleurs soins de santé grâce à des technologies novateurs

 

RENDEMENT DU BUREAU DES MATÉRIELS MÉDICAUX (BMM) DE SANTÉ CANADA


Based on current performance reports available from Health Canada there has been some significant backlog build-up in applications at the Medical Devices Bureau (MDB) in Q1 and Q2, FY 2016/17 due to substantial capacity shortage. Efforts were made by MDB to combat this trend, which led to noticeable improvements in Q3. The average Time to 1st Decision for a number of review lines was affected.

The current ‘Time to Market Authorization’ (time from application submission to licence issued including stop times for responding to Screening Deficiency Letters and/or Additional Information Requests by the applicants) for all classes of medical devices is on average between 2-3 times the published target timelines (= ‘Time to 1st Decision’).

Santé Canada note qu’actuellement 50 % des demandes au BMM présentent des lacunes et que 40 à 6 0 % des demandes sont examinées avec des demandes de renseignements complémentaires. Tandis que les demandes achevées sont analysées dans les temps prévus, les demandes incomplètes dépassent de 2 à 3 fois les délais prescrits.

MEDEC travaille avec Santé Canada afin de trouver des solutions aux problèmes de qualité des demandes et de rendement qui retardent l’accès au marché des produits.

Health Canada's Medical Devices Program Q1 2016/17 Performance Report - English and French.

 

Health Canada's Medical Devices Program Q2 2016/17 Performance Report -  English and French.

 

Health Canada's Medical Devices Program Q3 2016/17 Performance Report -  English and French.

 

Health Canada's Medical Device Bureau 2015/16 Annual Report can be found here (English) and here (French). 





 


 


Recherche
Accès membre


 

 

Medtech Canada is the national association representing the medical technology industry in Canada. Our association advocates for achieving patient access to leading edge, innovative technology solutions that provide valuable outcomes. Our members are committed to providing safe and innovative medical technologies that enhance the quality of patient care, improve patient access to health care, and help enable the sustainability of our health care system. The medical technology industry in Canada employs over 35,000 Canadians in approximately 1,500 facilities across the country.



Bureau de Toronto

900-405 The West Mall
Toronto, ON M9C 5J1
416.620.1915
1.866.586.3332
 

Bureau du Québec

204, Notre-Dame O.  Bureau 402
Montréal, Québec H2Y 1T3

(514) 217-1167