Blood Analysers in Community Pharmacies: What Is Allowed and What Makes Sense

In April 2026 the Health Ministry said blood taking for health screening may only happen at registered or licensed premises. What that means for a pharmacy, whether an FBC analyser fits one at all, and the routes that keep blood testing within the law.

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Also called Blood analyser for pharmacy, Pharmacy blood test machine, Pharmacy health screening

Published: 17 October 2026

Last updated: 16 October 2026

The April 2026 Health Ministry statement

On 30 April 2026 the Ministry of Health said that health screening services involving blood collection, including those offered by community pharmacies, may only be carried out at premises registered or licensed under the Private Healthcare Facilities and Services Act 1998 (Act 586). It called blood collection a clinical procedure that must meet safety standards, and said premises that collect blood are treated as providing healthcare services. The statement followed a call from the Federation of Private Medical Practitioners’ Associations Malaysia (FPMPAM) to act on blood taking in retail pharmacies.

The ministry put the penalty for providing the service without registration or a licence at a fine of up to RM500,000, up to six years in jail, or both, and said it would strengthen enforcement.
The statement speaks of blood taking, phlebotomy and blood collection in general. It does not set out a separate rule for finger-prick tests.
It also said the ministry recognises the role of community pharmacies in healthcare — the issue is where blood is collected, not pharmacy services as a whole.
Ask the Health Ministry’s private healthcare control unit (CKAPS) or your state health department how this applies to your premises, and keep the answer in writing, before you buy a meter or advertise a blood test.

The laws involved

A summary for orientation, not legal advice. Check the current position with the authorities.
Law	What it covers	Why it matters to a pharmacy
Private Healthcare Facilities and Services Act 1998 (Act 586)	Registration and licensing of private healthcare facilities and services	The basis of the April 2026 statement: premises that collect blood for screening must be registered or licensed under it
Pathology Laboratory Act 2007 (Act 674)	Licensing of private pathology laboratories	Passed in 2007, but FPMPAM said in April 2026 that it has never been put into operation. As passed, it excludes side-room laboratories in the clinics of registered doctors and dentists testing their own patients
Medical Device Act 2012 (Act 737)	Registration of medical devices, including IVD analysers, meters, strips and reagents	Every meter, analyser and reagent must be registered with the Medical Device Authority (MDA), whoever uses it

Finger-prick tests seen at pharmacy counters

These are the tests most often offered at pharmacy health-screening counters. Whether each may be offered on your premises after the April 2026 statement is a question for the authorities, not for this guide.

Test	Device	What it tells you	Limits
Blood glucose	Glucose meter and strips	A spot glucose for screening and self-monitoring	One reading does not diagnose diabetes
Cholesterol or lipid panel	Lipid meter and test cassettes	Total cholesterol, and on some meters HDL, triglycerides and a calculated LDL	Fasting status changes triglycerides
HbA1c	Benchtop point-of-care HbA1c analyser	Average glucose over the previous two to three months	Thalassaemia and other haemoglobin variants can affect some methods
Haemoglobin	Haemoglobin meter	A quick anaemia screen	Not a full blood count — no platelets, white cells or red-cell indices
Uric acid	Uric acid meter	A spot uric acid for gout follow-up	Varies with diet, alcohol and medicines

Does an FBC analyser make sense in a pharmacy?

For most stand-alone community pharmacies, the honest answer is no — and not only because of the rules.

It needs a blood sample

An FBC analyser runs on EDTA blood, normally from a vein. That is exactly the blood taking the April 2026 statement places inside registered or licensed premises.

Capillary FBC and its limits

Someone has to act on the result

An FBC is read with the patient’s symptoms and examination. A falling platelet count in dengue, a very high white count or a new anaemia needs a doctor’s decision the same day.

The daily cost runs regardless of volume

Start-up, background checks, controls and shutdown use reagent every working day. At a handful of samples, each reportable FBC becomes expensive.

Cost per test explained

Quality control is a daily job

Control blood, Levey-Jennings charts and external quality assessment are part of running an analyser responsibly, and they need trained staff and time.

Daily QC routine

Routes that keep blood testing within the law

A pharmacy with a registered clinic: where a doctor runs a private medical clinic registered under Act 586 on the same site, blood can be taken and an FBC run in the clinic for its patients. Check that the registration covers the room where the analyser sits.
Referral: send patients who need a blood test to a nearby clinic or licensed laboratory collection point, and keep the counselling and medicine follow-up at the pharmacy.
Screening without blood: blood pressure, weight, body mass index and waist circumference need no blood sample.
Whatever you use, ask for the MDA registration number of each meter, analyser and reagent and check it on the MDA public register.

Questions to settle before buying any blood-test device

Written confirmation from the authorities that the test may be offered on your premises.
Who collects the blood, their training, and how needlestick injuries are handled.
Sharps and blood-stained waste: clinical waste is scheduled waste (SW404) under the Environmental Quality (Scheduled Wastes) Regulations 2005 and needs a licensed contractor.
Who reviews each result, which results trigger a referral, and how quickly.
Quality control records for every meter and analyser, and how results are stored under the Personal Data Protection Act 2010.

Hematology Analyser supply near you

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Frequently asked questions

Can a pharmacy in Malaysia do blood tests?

On 30 April 2026 the Health Ministry said health screening that involves blood collection may only be carried out at premises registered or licensed under the Private Healthcare Facilities and Services Act 1998. Ask the ministry how this applies to your premises before offering any blood test.

Are finger-prick glucose and cholesterol tests affected?

The statement refers to blood taking and blood collection in general and does not single out finger-prick tests. Get written guidance from the ministry or your state health department rather than relying on what other pharmacies do.

Should a pharmacy buy an FBC machine?

Usually not. An FBC needs an EDTA blood sample, a doctor to act on the result, daily quality control and enough samples to justify the fixed reagent cost. A pharmacy with a registered clinic on site is the exception to consider.

What is the penalty for unlicensed blood collection?

The Health Ministry’s April 2026 statement put it at a fine of up to RM500,000, up to six years in jail, or both, for providing the service without registration or a valid licence.

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