In order to facilitate regulation of medical device with classification system as stipulated in medical device rules, 2017 among other aspects like sale and distribution, import and labeling of medical devices, Joint Secretary of Ministry of Health and Family Welfare (MoHFW) K L Sharma has permitted AMTZ to host a dedicated help desk for understanding and smooth implementation of Medical Device Rules, 2017.
The help desk would also facilitate information on following changes of medical devices rules to manufacturers like licensing authorities and functions of notified body, manufacture of medical devices for sale and distribution, import and labeling 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.
The Union health ministry notified the Medical Devices Rules, 2017 which will come into force from January 1, 2018.
These Rules will be applicable to substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i); substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).
Taking forward its mandate of Make in India, Government of Andhra Pradesh last year established country’s first medical technology manufacturing park, Andhra Pradesh MedTech Zone (AMTZ) in Vishakhapatnam. N Chandrababu Naidu, chief minister of Andhra Pradesh laid the foundation stone of AMTZ.
Since then, AMTZ has received good response in terms of commencing of booking of plots and its active participation at Indian Medical Device Conference – 2017, one of the largest events for the Indian pharmaceutical market.
Dr Jitendar Sharma, director and chief executive officer of AMTZ, said, “I am extremely thankful to Government 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.”
Proposed to be built on 271 acres of land with a seed capital of Rs. 25 crore, AMTZ will set up in-house high capital intensive common scientific facilities helping medical device manufacturers reduce the cost of manufacturing in the country.
The medical device park is proposed to have all such facilities in-house that are required for specialized product verticals to reduce manufacturing process costs. The park will provide modern state of art common facilities such as specialised laboratories, warehousing and a testing centre.
The AMTZ with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40 per cent to 50 per cent. Currently, due to lack of such centrally located shareable facilities, either manufacturers do not undertake production of technologies requiring them or send their products abroad for process up-gradation and value addition. While the zone would have all such facilities in-house to reduce manufacturing process costs, it would be located in an area which is well connected with railways, roadways, waterways and airways with near presence of industrial corridors, port and harbour to reduce logistical costs.