AMTZ to host “Help Desk on New Medical Devices Rules, 2017”
When Govt of India putting “Make in India” into effect, Last year Govt of Andhra Pradesh established country’s first Medical Technology Manufacturing Park, Andhra Pradesh MedTech Zone (AMTZ) in Vishakhapatnam. Shri N. Chandrababu Naidu, Honorable Chief Minister of Andhra Pradesh laid the stone foundation of AMTZ. Making a humble start from Vishakhapatnam, AMTZ is carving its own path to glorious successes month after month from its stone foundation day. AMTZ receives good response for its initiation, AiMED lauds AMTZ for commencing booking of plots and also applauded at Indian Medical Device Conference – 2017, was one of the largest events for the Indian pharmaceutical market, AMTZ occupied the center stage.
AMTZ shall be hosting Govt. of India’s “Help Desk of Medical Devices Rules, 2017” to Manufacturers.
Mr. K. L. Sharma, Joint Secretary, Ministry of Health & Family Welfare, Govt. of India permitted AMTZ to host a dedicated help desk for understanding and smooth implementation of Medical Device Rules, 2017. The Help Desk would facilitate information on following changes of Medical Devices Rules to Manufacturers:
- Regulation of Medical Device with Classification System
- Licensing Authorities and functions of Notified Body
- Manufacture of Medical Devices for Sale and Distribution
- Import & Labelling of medical Devices
- Clinical Investigation of Medical Device and Clinical Performance Evaluation of IVD’s
- Import or Manufacture Medical Device which does not have Predicative Device
- Duties of Medical Device Officer, Medical Device Testing Officer and Notified Body
- Registration of Laboratory for carrying out test for evaluation
- Sale of Medical Devices, etc,
Dr Jitendar Sharma, Director and CEO of AMTZ said, “I am extremely thankful to Govt of India for making first help Desk from AMTZ to support manufacturers in understanding of the new rules. This will go a long way in improving manufacturing potential”.