New KEBS calibration rules could affect hospitals, factories and laboratories

Hospitals, factories, laboratories and other institutions using precision measuring equipment could be required to calibrate their devices at least once every year under proposed government regulations.

The draft Standards (Scientific and Industrial Metrology) Regulations, 2026, place dozens of medical, industrial, scientific and environmental devices under mandatory calibration.

Equipment covered by the proposals includes blood pressure monitors, thermometers, ventilators, dialysis machines, X ray equipment, industrial scales, breathalysers, weather stations and air quality monitors.

Businesses offering calibration services would also need licences from the Kenya Bureau of Standards.

The proposals are intended to ensure that equipment used to make important health, safety, manufacturing and environmental decisions provides accurate results.

They could, however, introduce additional costs and compliance requirements for affected businesses and institutions.

The regulations have not yet taken effect. The government has invited businesses and members of the public to submit their views before they are finalised.

What is calibration?

Calibration involves comparing a measuring device with a recognised standard to establish whether it is providing accurate results.

A blood pressure monitor, for example, may continue displaying readings even when its internal measurements have become inaccurate.

The same problem can occur with industrial pressure gauges, laboratory analysers, weighing scales, thermometers and environmental monitoring equipment.

Small errors can have serious consequences.

An inaccurate medical device could influence a diagnosis or the amount of medicine delivered to a patient. A faulty industrial gauge could result in unsafe pressure or temperature levels. Incorrect laboratory equipment could produce unreliable test results.

Calibration does not necessarily repair a device. It establishes how accurate it is and whether it meets the required standard.

Which equipment will be affected?

The proposed regulations contain a broad schedule of devices that would require mandatory calibration.

In healthcare, the list includes:

Blood pressure monitors
Pulse oximeters
Thermometers
Infusion pumps
Electrocardiograph machines
X ray machines
MRI and CT scanners
Ultrasound and mammography machines
Ventilators
Defibrillators
Dialysis machines
Anaesthesia machines
Glucose meters
Laboratory microscopes and analysers
Medical refrigerators and freezers
Dental X ray machines
Radiation therapy equipment

Hospitals, clinics, dental practices, diagnostic centres, pharmacies and medical laboratories are among the institutions likely to be affected.

The industrial equipment listed includes pressure gauges, flow meters, temperature sensors, truck weighbridges, industrial scales, gas detectors, breathalysers, torque wrenches and fire safety equipment.

Manufacturers, engineering companies, oil and gas businesses, construction firms and vehicle inspection centres may therefore have additional obligations.

Environmental monitoring equipment is also covered. This includes air quality monitors, water testing devices, weather stations, noise meters, soil testing equipment and instruments used to measure industrial emissions.

The complete list is contained in the first schedule of the proposed regulations.

How often must equipment be calibrated?

Equipment covered by the regulations would generally have to be calibrated at least once every year.

A different period could apply where a specific standard or manufacturer’s specification requires more frequent checks.

Businesses and institutions operating the listed equipment would have three months from the date the regulations begin to obtain valid calibration.

Once a device has passed the assessment, the organisation carrying out the work would issue a calibration certificate.

The certificate would normally remain valid for one year.

However, its validity would end if the equipment is repaired, overloaded, mishandled or subjected to an incident that could affect its accuracy. The equipment would then have to be calibrated again before it returns to use.

Who will carry out the checks?

Calibration would be undertaken by KEBS, an institute designated by the bureau or a private provider licensed under the regulations.

KEBS would become Kenya’s National Metrology Institute, making it responsible for maintaining national measurement standards and linking them to internationally recognised units of measurement.

This is meant to ensure that a measurement taken in a Kenyan hospital, laboratory or factory can be traced back to an accepted national or international standard.

KEBS would also maintain public registers of designated institutes and licensed calibration service providers.

This could help businesses confirm whether a company offering calibration services is authorised.

New licences for service providers

Every person or company offering calibration services in Kenya would be required to obtain a KEBS licence.

To qualify, an applicant would need to:

Be accredited for the relevant area of calibration
Be registered as a business in Kenya
Have a physical address in Kenya
Provide an inventory of its measurement standards
Demonstrate that its standards are traceable to national standards
Show that it has qualified personnel

A licence would be valid for two years.

The proposed application fee is Sh10,000 for each area of calibration. A successful applicant would then pay a licence fee of Sh50,000 for each area.

Renewal would cost another Sh50,000 per area, with applications required at least three months before the licence expires.

A company seeking permission to calibrate temperature equipment and medical weighing devices, for example, could be required to apply and pay separately for each approved area.

That may increase the cost of entering or remaining in the calibration business, particularly for smaller service providers.

Will businesses pay more?

The regulations are likely to create direct costs for institutions that own the listed equipment.

They may need to pay for annual calibration, maintain certificates, schedule equipment to be taken out of use and repeat calibration after certain repairs.

Calibration companies will also face accreditation, licensing, staffing and equipment costs.

The government’s regulatory assessment acknowledges that the rules are likely to impose costs on calibration providers. It argues that the wider benefits will include fewer measurement errors, improved product quality, safer healthcare and greater acceptance of Kenyan test results in international markets.

Some costs may eventually be passed to customers through prices charged by hospitals, laboratories, manufacturers and testing facilities.

However, the draft does not establish how much calibration will cost equipment owners. It would therefore be premature to conclude that consumer prices will automatically rise.

The final effect will depend on the fees charged by KEBS and licensed providers, the number of devices an institution owns and how frequently they require calibration.

What happens to those who do not comply?

KEBS would be responsible for enforcing the regulations.

The bureau would have the authority to inspect calibration providers, monitor their activities and seize precision measuring equipment used in violation of the rules.

It could also publish notices warning the public about equipment that has not been calibrated and may pose a risk to health, safety or the environment.

Offering calibration services without a valid licence would become an offence.

Businesses affected by a KEBS decision would be able to request a review or appeal to the Standards Tribunal within 14 days.

Before suspending or revoking a provider’s licence, KEBS would be required to give written reasons and allow the provider 14 days to respond.

Consumers could also benefit

The proposals are not only about regulatory compliance.

Accurate measurements determine whether patients receive the correct treatment, products meet the required specifications and environmental pollution is properly recorded.

They can also protect businesses from losses caused by faulty equipment, rejected products, repeated manufacturing work or unreliable laboratory findings.

Kenya’s current calibration framework is described in the regulatory assessment as fragmented, with voluntary practices in several sectors and limited oversight of providers.

The government says this has led to inconsistent measurements and made it harder for some Kenyan test results and products to gain international acceptance.

Public invited to give views

The Ministry of Investments, Trade and Industry published notice of the proposals on September 4.

Businesses, professional bodies, hospitals, laboratories, manufacturers, universities and members of the public have been given 14 days from publication to submit written memoranda to the KEBS managing director.

Affected organisations should examine whether their equipment appears in the schedule, how many devices would require annual calibration and whether enough licensed providers would be available across the country.

They should also consider whether three months would be sufficient to bring all covered equipment into compliance.

Until the consultation process is completed and the regulations are formally adopted, the requirements remain proposals rather than enforceable rules.

Category: Lifestyle