All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of:
- diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
- diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
- investigation, replacement or modification or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- disinfection of medical devices; and
- control of conception.
In short, it’s an implement that is used for medical purposes — and can range from hospital equipment to mechanisms aimed at helping sick patients to consumer products. In all cases, anything that is classified as a medical device is subject to country-specific regulations regarding production and quality control. In India, the CDSCO (Centre for Drugs Standards Control Organization) is responsible for such regulations.
Wondering, how are they subdivided per Indian regulations? Here’s what you need to know. More specifically, the CDSCO has four medical device classifications for in-vitro & other than in-vitro medical devices:
- Class A - Low Risk
- Class B - Low Moderate Risk
- Class C - Moderate High Risk
- Class D - High Risk
Each class has its own regulations around production — with class C & D being the strictest. Crescenzia Wellness may produce certain class A and class B medical devices because we are ISO 13485:2016 certified. This means that our production, process documentation, and quality control procedures meet the required controls put forth by the International Standards Organization (ISO).
As you can imagine, this encompasses a lot of things we use every day. Did you know that wheelchairs and band-aids are technically class A medical devices? For a medical device manufacturer, this means that producing band-aids requires more oversight than manufacturing a toy.
