CDSCO Medical Devices FAQs 2024 Part-2 | Pharmadocx Consultants

[@AliAshif8719]

Well define sir🙏

[@pharmadocxconsultants1345]

Thanks sir

[@supervaluepharma9754]

Can an innovator appeal for revision of risk class for his or her innovation ?

[@pharmadocxconsultants1345]

@@supervaluepharma9754 yes he can provided it’s based on logical scientific grounds as per Risk Chart of MDR2017

[@srinivasprasanna.v.c.6364]

Sir, Should a design house for SW & HW for medical device should get registered in CDSCO and / Or should they have a license/lone license ?

[@pharmadocxconsultants1345]

Yes it’s needed