Jab hum health regulation sochte hain, dimaag me drugs aate hain. Lekin medical devices – stents, implants, ventilators, surgical tools, diagnostic kits – bhi equally high-risk category me aate hain. Inka regulation historically weaker tha, lekin ab dedicated frameworks emerge ho rahe hain.
Medicines ke liye focus hota hai clinical trials, dosage, side-effects, pharmacovigilance. Devices ke liye questions alag hain:
- Design and manufacturing standards,
- Materials used, sterility, durability,
- Performance testing and failure rates,
- Post-market surveillance and recall mechanisms.
Classification usually risk-based hoti hai – simple bandages vs pacemakers obvious same level ke scrutiny deserve nahi karte. Labelling, instructions for use, and training requirements bhi tightly controlled hone chahiye, specially complex devices ke liye.
Grey market supplies, cheap counterfeits, aur “unapproved but popular” devices patient safety ke liye real threat hain. Hospitals and doctors ko procurement me due diligence karni chahiye; lowest price always best nahi hota.
Regulation ka aim industry ko choke karna nahi, balki ensure karna hai ki hospital ke andar use hone wala hardware khud disease ka naya source na ban jaye.
