Health Policy 2457

AMTZ to host first help desk on new medical devices rules

The Andhra Pradesh MedTech Zone (AMTZ) has been chosen to host Government of India’s first dedicated ‘help desk of medical devices rules, 2017’ to facilitate free flow of information to medical device manufacturers and help improve “manufacturing potential” of the sector.

KL Sharma, Joint Secretary, Ministry of Health  and Family Welfare, Government of India, permitted AMTZ to host a dedicated help desk for understanding and smooth implementation of Medical Device Rules, 2017.

Expressing his thoughts on this initiative, Dr Jitendar Sharma, Director and CEO of AMTZ, said, “I am extremely thankful to Government of India for making first help desk from AMTZ to support manufacturers in understanding the new rules. This will go a long way in improving manufacturing potential.”

The help desk will function as a single point of contact for medical devices manufacturers to access infomation regarding the changes in Medical Devices Rules. It will facilitate information on regulation of medical device with classification system; licensing authorities and functions of notified body; manufacture of medical devices for sale and distribution; import and labelling of medical devices; and clinical investigation of medical device and clinical performance evaluation of IVD’s.

The AMTZ desk would also provide information to manufacturers on import or manufacture of medical device which do 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; and sale of medical devices, etc.

The government has come up with separate regulatory norms for medical devices to boost production under the ‘Make in India’ initiative.

Last year, Government of Andhra Pradesh established country’s first medical technology manufacturing park — Andhra Pradesh MedTech Zone in Vishakhapatnam. N Chandrababu Naidu, Chief Minister of Andhra Pradesh, laid the stone foundation of AMTZ.

Making a humble start, AMTZ is growing from strength to strength to carve out its own path to help India emerge as a global hub for medical device manufacturing.

Owing to the good response AMTZ has received, the Association of Indian Medical Device Industry (AiMED) has lauded the first ultra modern medical equipment manufacturing zone of India for commencing booking of plots. AMTZ also received applauds at Indian Medical Device Conference – 2017, one of the largest events for the Indian pharmaceutical market, where AMTZ occupied the centre stage.

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