‘We Plan To Double Our Headcount In The Next Two Years’

Underwriters Laboratories Inc (UL) is an independent, not-for-profit product-safety testing and certification organisation. Since its founding in 1894, it has become a leader in product-safety testing and certification within the US and later on worldwide. Jibu Mathews, Business Manager, HiTech, UL India Private Limited, whose current work involves providing regulatory requirements and product safety certifications for various kinds of medical devices for the global markets and its clients, tells Express Healthcare Management about certification for medical equipment

What is the current market trend in medical equipment certification in India and how UL proposes to operate and market itself in this field in India?

Medical equipment certification is a vast and rapidly-evolving field that is often complicated by legal technicalities. In India, certifications are largely done for MNCs and a few SMEs as they target toward exports to the international markets. Most of the devices are certified for CE mark, UL mark and some to FDA.

India is fully geared up to meet the requirements on regulatory, testing, evaluation and certification needs for India and international markets. We have our own independent test lab and also partner with various government labs for testing and evaluations. UL aims to provide Indian manufacturers a one-stop-shop solution for all their global regulatory and certification requirements.

Please comment on the Union Health Ministry’s recent decision to regulate quality of  medical devices.

Asian countries, particularly India, is making vast industry improvements to attract more outsourcing business and also cater to the growing medical device opportunities in Asian markets. It’s a welcome move to introduce certification to regulate the quality of medical equipment. This provides a future roadmap for manufacturers to meet quality standards and also access and compete in international markets. Presently, these regulations are confined only to in-vivo devices and probably could extend to electro-medical equipment also.

How UL can help the regulatory bodies such as Central Drugs Standard Control Organisation (CDSCO) towards formulating medical standards?

UL can provide technical inputs on requirements of the International Standards (IEC 60601-1, EMI/EMC), country deviations, providing test plans and compliance evaluation of medical equipment.

How different is UL from other certifications like CE or FDA?

UL mark is the world’s most instantly recognised and trusted symbol and assures customers that the products certified by UL have been independently verified for safety, quality and reliability and are market-driven marks. UL marks adds value to customers products and helps entry in most demanding markets be it Europe, North or South America, Asia or the Middle East. CE or FDA are regulatory in nature and are mandatory for one to enter the markets such as the Europe & USA. UL is also a notified body for medical devices and can certify and review products for CE, FDA and ISO 13485 a Quality Management system for medical device manufactures.

What is the market strength of UL?

UL is the largest player in the global certifications business with a market share in excess of 60 per cent.

As of now, in which countries is UL based at? Is it applicable only in the US?

UL has presence in 96 countries with 62 laboratory, testing and certification facilities in the UL family of companies. UL is not only applicable in the US, but also in demanding markets such as Europe, Asia and the Middle East and is also the notified body for medical devices.

Any expansion plans in India as well as other countries especially Asia Pacific?

UL India with its in-house test lab is also the regional hub for emerging markets such as South East Asia, ANZ and Middle East regions. We plan to double our headcount in the next two years.

How should one apply for UL? How long does it take to certify and what is the cost involved?

Any customer can apply to UL online (www.ul.co.in) or write to customerservice.in@in.ul.com, providing details of the product. Typically, UL mark takes about four to eight weeks in testing and certification and the cost is dependent on the type and construction of the product.