Medical Devices Committee

AMCHAM submitted regulatory concerns relating to medical device components to Mr. Darpan Jain, Additional Secretary, Ministry of Commerce, Government of India, requesting appropriate policy intervention to facilitate the exemption of components and spare parts that do not possess an independent intended medical purpose or standalone clinical functionality from separate regulatory classification and compliance requirements.

AMCHAM sent a representation to the Ministry of Labor and Employment, Government of India urging the government to have a stakeholder consultation of rideshare and e-commerce platforms on social security framework for gig and platform workers. This is crucial in view of the significant contributions of these sectors to the gig economy, in order to ensure that the rollout of the Code on Social Security (CoSS) and its effective implementation is comprehensive and inclusive of the varied challenges and opportunities across the gig ecosystem.

Over the years, the Indian Infrastructure and real estate sector has experienced a significant transformation, with the emergence of Real Estate Investment Trusts (REITs) and Infrastructure Investment Funds (InvITs), playing a pivotal role in revitalizing the…

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,…

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 of Environment, Forest and Climate Change on August 1st, 2022. The representation…

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…

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…

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).

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’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).