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New regulations for Medical devices are in place including the IVDs market.







New regulations for Medical devices are in place including the IVDs market. These are subject to be commented by Industry as such. Over all this is a welcomed step. Medical devices industry is growing at greater pace.

Bringing in regulations to regulate the devices, their use and disposal is very much a need in the present scenario. WHO bringing in regulation developed by Global Harmonization Task Force and the International Medical Device Regulators Forum will be applicable to all the working members under WHO umbrella. Since Medical devices including the IVDs are subject to risks both for Individual and for public health. Bringing in regulation over the same is much of a need.


Ensuring that a Medical device consistently conforms to the essential principles is not only responsibility of manufacturer but also the industry in which it functions.

Making the norms stringent, the documented evidence of conformity is subject to review by the regulatory authority before or after market introduction as stated by WHO.

The degree of involvement of the regulatory authority in the assessment of a medical device is dependent on the risk class.  In our view point this is good news for the industry as well as for the end user i.e. the patients.

Regulations will ensure that risk associated with device is totally removed as such. It will bring in the credibility towards the industry practice and chalk out the defaulters.

However, keeping close eye over the malpractices in the industry has to be looked over as there are chances for its existence even though regulations are in place.

Bringing in harmonization in the practice and code of conduct will ensure better output for the industry as such.



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