Medical devices – stents, implants, pacemakers, monitors, syringes – modern healthcare ke backbone hain. Inka regulation medicines se thoda alag, par utna hi critical hai.
Rules generally classify devices risk level ke basis par: low-risk bandages se leke high-risk heart valves tak. Har category ke liye design standards, clinical evaluation, manufacturing quality systems, aur post-market surveillance requirements hoti hain.
Problems tab bante hain jab cheap, unapproved imports market flood kar dete hain, ya hospitals cost-cutting me dubious suppliers use karte hain. Device failure patient ke body ke andar direct harm ka risk layaata hai.
Regulators approvals, audits, adverse incident reporting systems, aur sometimes device registry maintain karte hain. Hospitals ko procurement policy transparent rakni chahiye, doctors ko conflict-of-interest avoid karna chahiye.
Patient ko brand/model ke records, implant card, and follow-up advice carefully preserve karni chahiye – future replacement ya recall cases me ye hi lifeline hoti hai.