In the India Gazette 33004/99 the Ministry of Health published the new "medical device rules 2017".
The official text is published in Indian and english language.
This version is replacing the previous draft version that we already published in our News-Blog in 2016.
The "medical device rules 2017" shall enter into force on 2018-01-01
The scope covers IVD in general but not all Medical devices!
At present the following medical devices fall under the scope:
- substances used for in vitro diagnosis
- and surgical dressings,
- surgical bandages,
- surgical staples,
- surgical sutures,
- blood and blood component collection bag with or without anticoagulant
- substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings),
- disinfectants and insecticides notified
- devices notified from time to time (!)
As a consequence of this it is important to monitor the list of products covered under the scope of the regulation.
Please also see our following news.