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Assistance on MDAC Meetings

Assistance on MDAC Meetings

Introduction

The Medical Device Advisory Committee (MDAC) was created in an effort to advice the Drugs Controller General of India (DCGI) and the Central Drugs Standard Control Organization (CDSCO). The MDAC reviews the rules and regulations of medical devices and clinical trials and then instructs the DCG(I). As per the MDAC’s supervision and suggestions, all clinical trials and medical devices in the country must adhere to the guidelines set thereof.

The seasoned team of professionals at CliniExperts is here to assist you to obtain the necessary approvals of your medical device by assuring all the aspects of the guidelines are covered. Our main objective is to aid in faster approval of manufacture or import of medical device by being cost-effective and creative at the same time.

Assistance on MDAC Meeting for Medical Devices

The MDAC members hold office to a term of 3 years. However, they can be eligible for re-nomination given they are nominated by their virtue. If a member retires during term, an alternative member will be nominated to replace the previous member. Each expert will be paid an honorarium of Rs. 1000/- to review each proposal. The members of the MDAC may be called upon to advise on the following instances:

  • In-depth evaluation of clinical and non-clinical trials for new medical devices and global clinical trials
  • Recognize the devices that needed for be notified by the CDSCO
  • Make standards for clinical trials and criteria for marketing approval
  • Outline a roadmap for research for appropriate development of new medical devices that are relevant to India
  • Adequate research performed by the firm
  • Study performed in significant population group
  • Examine the new medical device in relation to:
    • Risk versus benefit
    • Innovation
    • Medical need of it in India

The meetings held by the MDAC discuss the upcoming medical devices and whether to approve the manufacture or import of the medical devices. Furthermore, the recommendations provided by the committee helps the firms know what else could be done to improve the device and help the patients of India. CliniExperts ensures you are thoroughly equipped to clear these meetings and have all the necessary forms and details handy. This ensures speedy glitch free clearance throughout the meetings and timely launches of the medical device in the Indian market.

CliniExperts: Your one-stop shop

  1. We cater to our customers from start through finish in a timely manner so that the MDAC can also provide a quick decision.
  2. We offer complete support for our customers to overcome the hurdles associated with the provisions of the Drugs and Cosmetics Act, 1940 & Rules, 1945 in relation to the medical devices.
  3. We help our customers understand and fill out all the forms required for their procedures for the committee.
  4. We strive for success and customer satisfaction which means we also aid in any post-approval changes of the medical device such as name change or address change.