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Furley Bioextracts

Manufacturing certifications

Manufacturing certifications are the standards and approvals that show how a factory controls quality, safety and compliance. Quality sits at the centre of how Furley Bioextracts manufactures. These are the certifications and regulatory frameworks we work with.

Our two headline certifications are ISO 13485, the quality management standard for medical devices, and FSSC 22000, a recognised food safety system certification.

Key takeaways

  • We hold ISO 13485 and FSSC 22000, and work with Food Halal, GMP, HACCP, NPRA and FDA.
  • Which one applies depends on your product category.
  • We support NPRA notification and registration for Malaysia.

Which manufacturing certifications does Furley work with?

  • Food Halal – Halal certification for food products.
  • ISO 13485 – The international quality management standard for medical devices. See the ISO 13485 standard.
  • FSSC 22000 – A food safety system certification scheme. See FSSC.
  • GMP – Good Manufacturing Practice, the baseline for consistent, documented production.
  • HACCP – Hazard Analysis and Critical Control Points, a food safety framework.
  • NPRA – Malaysia’s National Pharmaceutical Regulatory Agency under the Ministry of Health. It oversees the notification and registration of health products and cosmetics. See NPRA.
  • FDA – The United States Food and Drug Administration, relevant to products intended for the US market. See the FDA.

Why do certifications matter to brand owners?

When you launch under your own name, your customers trust you, not the factory. Working with a manufacturer that follows recognised standards helps you meet retailer and regulator expectations and lowers the risk of delays.

Contact us and we will explain what is relevant for your product. See also our manufacturing services.

Certification questions

Which certification applies to my product?

It depends on the category. Food products are guided by Food Halal, FSSC 22000 and HACCP. Medical devices such as wound care relate to ISO 13485. Supplements and cosmetics are guided by GMP and NPRA requirements.

Can you help with NPRA documents?

Yes. We support the documentation for NPRA notification and registration of products sold in Malaysia.

Do you support export markets?

We can advise on what export markets, including the US FDA, expect for your product category. Contact us with your target market.

Need to know what applies to your product?

Tell us what you plan to make and where you plan to sell it.

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Call +603-8724-3280

Call +603-8724-3280  |  Email [email protected]