Leading the Way Through Standards

Medical-Latex (DUA) SDN BHD prides itself on adhering to the highest regulatory standards in its manufacturing and in the marketing of its products in new and innovative ways. For example, it proudly collaborates with SIRIM and the Malaysian Government to develop quality standards for condoms in the ISO TC 157 besides participating in other regional regulatory meetings in Asia and around the world.

ISO, DIN, CE, FDA...

With condoms that are manufactured to meet international standards, Medical-Latex (DUA) SDN BHD and its facilities are already certified to standards like the EN ISO 9001 and EN ISO 13485; and the Medical Devices Directive 93/42/EEC (Annexe II, Sect. 3) by German notified body DEKRA and to ISO14001, OHSAS 18001 by AFNOR.

World's Leading Certificates

The company is also proud that it has been accorded the British Standards Institute (BSI); France's Laboratoire National D'ESSAIS (LNE); China’s healthcare authority’s CCC; Singapore’s PSB Tick Mark quality seals besides several other national and regional quality marks. Recently we were also awarded the ISO 14001:2004 and OHSAS 18001:2007 certificates by AFNOR.

CSR Efforts

Focused on Innovation, Quality and Consumer Satisfaction, the company is also driven by a unique and strong Corporate Social Responsibility effort. This includes offering assistance to groups that want to learn more about how condoms are made; educational efforts that include ground activities,

	DEKRA (Notified Body): ISO 13485:2003 (Annex II); ISO9001:2008; 93/42/ECC (CE Mark)
	BSI Kitemark (4074)
	CSFDA Certificate
	NF Mark (ISO 4074)
	UNFPA/WHO Premarket approval
	510K Premarket FDA
	Tick Mark
	ISO 14001:2004, OHSAS 18001:2007

advertising, online campaigns and public relations campaigns; and community outreach efforts to different strata of society around the world.



These are strong testimonies of the company’s uncompromising quality standards that have contributed to our reputation as one of the leading premium quality manufacturers in this field today.