Regulatory & safety information
Everything sold here is a medical device. This page sets out what that means, how these products are meant to be used, and what to do if something goes wrong.
Last updated
Needs your review: This page exists because you sell medical devices, and it is the one page on the site with real regulatory weight. It needs three things only you can supply: your NMRA registration or import licence number, the manufacturer and country of origin for the products you carry, and confirmation of which device class they fall under. The placeholders below are marked. Have a regulatory consultant check it before launch.
These products support recovery. They do not replace medical care.
If you have severe or worsening pain, numbness, loss of circulation, an open wound, or a suspected fracture, see a doctor or physiotherapist before using any support or brace.
Regulatory status
Orthopaedic supports, braces and compression bandages are medical devices. In Sri Lanka their import and sale is regulated by the National Medicines Regulatory Authority (NMRA) under the National Medicines Regulatory Authority Act No. 5 of 2015.
Needs your review: Insert your NMRA registration or import licence number here, and the registration numbers of the devices themselves where they hold them. Buyers — especially hospitals and tender committees — will look for this.
MD Lanka (Pvt) Ltd supplies genuine stock obtained through authorised distribution channels. We do not sell reconditioned, grey-market or counterfeit product.
Intended use
The supports and braces sold here are intended for external, non-invasive use to:
- provide compression and support to a joint or soft tissue;
- limit or control the range of movement of a joint;
- relieve load on a muscle, tendon or ligament during recovery;
- immobilise a limb where a clinician has directed it.
They are not implants, they are not sterile, and they are not intended to treat any condition on their own. A brace is an aid to a treatment plan, not the treatment.
Who should not use them
Do not use a support or brace, or seek advice first, if you have:
- an open wound, skin infection or active dermatitis at the site;
- known circulatory problems, deep vein thrombosis or lymphoedema;
- reduced sensation at the site, including from diabetic neuropathy;
- a known allergy to latex, neoprene or elastane;
- a suspected fracture or dislocation that has not been assessed.
Using them safely
- Follow the manufacturer's instructions supplied with the product.
- Fit firmly, not tightly. If you feel tingling, numbness, throbbing, or the skin beyond the support becomes pale, cold or blue, remove it at once.
- Do not sleep in a compression support unless a clinician has told you to.
- Check the skin underneath daily for redness, rubbing or breakdown.
- Stop using it and seek advice if pain increases, or if there is no improvement after the period your clinician expected.
- Elastic and fabric fatigue with use. A support that has gone slack no longer does its job and should be replaced.
Sizing
A support that is the wrong size will not work and may cause harm. Measure before you order — our sizing and fitting guide shows how, and we will check your measurements with you free of charge before you buy.
Reporting a problem
If a product causes injury, deteriorates unexpectedly, or appears to be defective or counterfeit, tell us. Report it to sales@mdlanka.lk or call +94 11 234 5678 with your order number, the product code, and what happened.
Keep the product and its packaging — we may need to return it to the manufacturer. Serious incidents are escalated to the supplier and, where required, reported to the NMRA.
Not medical advice
Information on this site, including product descriptions and fitting guidance, is general information about the products we sell. It is not a diagnosis, a prescription, or a substitute for advice from a doctor, physiotherapist or orthotist. Always follow your clinician's instructions where they differ from anything written here.