AMTZ partners with GMDN Agency for identification of medical devicesPublish Date : Jun 03, 2017
Attracting attention of medical device fraternity across the world, the Andhra Pradesh MedTech Zone (AMTZ) recently joined the Global Medical Device Nomenclature (GMDN) Agency as partners.
The GMDN Agency is responsible for the Global Medical Device Nomenclature used for identification of medical devices. Formed in 1991, medical device experts from around the world (regulators, healthcare providers and manufacturers) have compiled the GMDN to facilitate taxonomy on medical devices.
GMDN is a list of generic names used to identify all medical device products including those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
A standardized and unambiguous system for naming and coding medical devices is critical in an environment increasingly dependent on electronic data records for sharing and storing patient information. GMDN is recommended by the International Medical Device Regulators Forum (IMDRF) and is now used by over 70 national
medical device regulators to support their activity.
With AMTZ as a Consulting Organisation to GMDN, it will be a great value-addition to all the manufacturers at AMTZ. GMDN association with AMTZ will come as an enabler of export and global market expansion potential.
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, Union Health Ministry 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.
Taking forward its mandate of Make in India, Government of Andhra Pradesh last year established country’s first medical technology manufacturing park, 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.
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).