What’s In A Certification?

What’s In A Certification?

All medical products have several forms of certifications to ensure they meet international standards. As a buyer, what sort of certifications should you be looking for?

Across industries, standards are an important way to safeguard product conformity while simultaneously harmonizing requirements both nationally and internationally. There is probably no other industry in which product conformity is as crucial as in the design and manufacture of medical consumables, furniture and devices. While each country may have its own certifications, here are two of the common ones that clearly represent quality products and production processes.

The ‘CE’ mark

CE marking is a product conformity certification with health, safety and environmental standards within European Territory. It certifies that the product or device is fit for its intended purpose stated and meets legislation relating to European market standards. This standard is a self-certification by the manufacturer after following testing and compliance for CE standards. If companies market their own brands, then their products can carry the CE mark from the manufacturer, if they have one.

Buyers should note the CE mark is commonly misused or confused with China Export (CE) and several fraudulent products carry this abbreviation which has no affiliation with actual certification.

The FDA certification

Issued by the Federal Drug Authority in the United States, the FDA is a certification for medical products and devices that ensure compliance to American standards for such products. FDA uses a Tier-based approval – Tier 3 being for critical devices such as infusion pumps to Tier 1 being for regular consumables such as bandages and gloves. All items imported into the US, which fall under FDA purview, will have to carry this certification and their imports maybe denied if found non-compliant.

FDA standards assess the device ‘effectiveness’ and also tests against any harm that it could cause for humans. Due to this difference in standards for testing and approvals in CE and FDA, buyers often imagine that an FDA marked product is better that one marked with a CE – this need not necessarily be the case.

Everything that we produce and distribute at HEAL ME Solutions carries the CE, FDA and ISO certifications. We ensure that our products meet local country certifications and regulations and only work with suppliers who have a string track record of complying with such world-class practices.


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