Standards · Standard or regulation
WHO medical device guidance
World Health Organization guidance on medical device management and regulation
In plain words
What it covers.
The WHO publishes guidance to help countries regulate and manage medical devices, including the Global Model Regulatory Framework, the medical device technical series on inventory, maintenance and procurement, and lists of priority devices. It is especially useful in settings with limited resources.
Who uses it: Ministries of health, regulators, hospital managers and clinical engineers, especially in low and middle income settings.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Global Model Regulatory Framework for medical devices
- Medical equipment maintenance programmes
- Inventory management
- Procurement processes
- Donations of medical equipment
- Post-market surveillance
Key points
What engineers need to know.
- Health technology management covers the whole life: plan, buy, install, use, maintain, dispose.
- An accurate inventory is the foundation of any maintenance programme.
- Donated equipment must fit local power, consumables, skills and service support.
- Countries are encouraged to build regulation step by step, starting with basic controls.
- Post-market surveillance and vigilance protect patients across borders.
- Guidance must be adapted to local context, not copied blindly.
Medical City
Where you practise it.
- S3-M118 international advisory
- S3-M130 WHO guidance published
- S1-M109 remote hospital
- S2-M174 overseas brief