Medical Devices Committee

[et_pb_section fb_built=”1″ admin_label=”section” _builder_version=”4.16″ hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][et_pb_row admin_label=”row” _builder_version=”4.16″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” min_height=”221px” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text admin_label=”Text” _builder_version=”4.17.4″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″] AMCHAM’s Medical Device Committee made a representation on consideration to exempt medical devices as listed under Schedule I of S.O. 360 (E) to Ms. Leena Nandan, Secretary, Ministry

[et_pb_section fb_built=”1″ admin_label=”section” _builder_version=”4.16″ global_colors_info=”{}”][et_pb_row admin_label=”row” _builder_version=”4.16″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text admin_label=”Text” _builder_version=”4.17.4″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″] AMCHAM’s Medical Device Committee made a representation on streamlining medical device registration process/regulatory challenges to Major General Mohammad Yousuf, Director General, Directorate General of Drug Administration, Ministry of Health & Welfare,

Medical Device Committee submitted the observations and shared inputs /suggestions to improve the Research development of Medical Devices”. Submitted recommendations pertaining Standards of Medical Devices – AMCHAM industry members believes that this is a very pragmatic approach and hope that emphasis will be laid on horizontal QMS standards and onus will be on the innovative

AMCHAM Medical Device Committee submitted recommendations to use TMR from PTD as a pricing mechanism to make medical devices more affordable for the patients. AMCHAM recommendations also suggested Therapeutic /Price band approach. Recommended to have a detailed industry consultations separately to evolve a suitable methodology for identifying products which need to go for TMR. Recommendations

AmCham jointly with AdvaMed had submitted comments on Draft Medical Devices Rules to  the Ministry of Health & Family Welfare on 30th August 2016. (This document is not for public disclosure).

AmCham submitted recommendations on issues concerning the medical devices industry to Prof. Dr. Jagdish Prasad, Directorate General Health Services (DGHS) on 7th October 2016. (This document is not for public disclosure).

AmCham’s Medical Devices Committee  submitted pre-budget recommendations for the medical devices sector to Department of Pharmaceuticals (DoP) on 10th November 2016. (This document is not for public disclosure).

AmCham and AdvaMed jointly submitted recommendations on Medical Devices Rule vide Gazette Notification 983(E) to the Ministry of Health & Family Welfare (MoHFW)  on 16th November 2016. (This document is not for public disclosure).

AmCham-AdvaMed provided comments on the new medical device rules to the Ministry of Health & Family Welfare (MoHFW) on 29th December 2016. (This document is not for public disclosure).