The Medical Device Dozen

10 May 2009 (Last Updated May 10th, 2009 18:30)

The medical device sector is a veritable hive of competition mixed with strict legislation. For a multinational looking to have global success, staying on top of current regulation is just as important as keeping up with its peers. Global Markets Direct breaks down the rules and regulations of the top 12 markets.

The Medical Device Dozen

Ageing populations, advances in medical technology and rising incidences of lifestyle diseases are contributing to the medical device sector being one of the most vibrant industries within healthcare. From the turn of the millennium it had a compound annual growth rate (CAGR) of 6.3% until 2007 – a growth expected to accelerate to 9.4% up to 2012.

A rising expectation for better quality of care means that investors' eyes are cast towards the opportunities that lie in cardiovascular devices, in-vitro diagnostics, orthopaedic devices and diagnostic imaging. But as Global Market Direct's Global Medical Equipment Industry Regulatory Outlook shows, regulation differs vastly from one locality to the next.

Asia Pacific opportunities

India and Australia are predicted to have a CAGR of above 13% until 2012. The market in Australia is settling down from the five-year transition period to provide a new medical device regulatory framework that ended in 2007. The new system aimed to harmonise Australian medical device regulatory standards with those internationally accepted.

"From the turn of the millennium the medical device sector had a compound annual growth rate (CAGR) of 6.3% until 2007."

In addition, the Australian Government is considering further reforms aimed at improving transparency and the availability of customer information. It hopes to implement an improved post-market monitoring process and introduce a business improvement programme. Together these should result in improved regulatory condition, greater efficiency and enhanced accuracy of application submissions.

Meanwhile in India, it was not until 2006 that attention began to be placed on the regulation of the sector – before which there was no governing body in place to monitor products in the market place. Global Markets Direct says that the Indian Government has now been "dragging its decision over the regulation of medical devices for more than three years".

India's Ministry of Health and Family Welfare currently regulates devices and is planning a major amendment to the existing drug laws to include comprehensive device regulation norms. It is also working on Good Manufacturing Practice guidelines for medical device manufacturers.

China and Japan are the other strong players in the Asia Pacific region, with both expected to witness a CAGR of over 10% until 2012. Established eight years ago, China's regulation has been regularly revised to try and increase its transparency. In addition, the country's National Development Reform Commission has agreed to get input from the US Government and major stakeholders on its revised draft pricing policy.

Japan's medical equipment industry has displayed steady growth of between 2% and 4% over the past decade. On the regulatory front, the environment has changed considerably since the introduction of the Pharmaceutical Affairs Law which was enacted in 2005. But despite this effort to harmonise past rules, the country still has the slowest and most cumbersome regulatory process of any of the major industrialised countries, according to Global Markets Direct.

America's activities

In Canada it is the Medical Devices Bureau that is responsible for formulating standards and processing licenses for medical equipment applications. The Canadian mindset is focused on harmonisation and the country follows a risk-based system of regulating devices in keeping with international standards.

"The US contributes to about half of the global medical equipment market and consumes about 40% of its output."

While Canada is expected to experience a CAGR of just over 8% in the next three years, the US is predicted to fare slightly better with a growth rate of 9.2%. The US contributes to about half of the global medical equipment market and consumes about 40% of its output. The sector has also heavily invested in R&D, resulting in high-quality equipment that uses advanced technologies.

Approval periods at the US FDA have been steadily declining and the trend is continuing, which is impacting the US market positively. In addition, the regulator is in the process of developing draft regulations to implement requirements listed in the FDA Amendments Act of 2007, from which a unique identification system will be established.

Meanwhile, it is Brazil that solely represents South America in the top dozen nations. Its medical equipment market grew at a CAGR of 6.3% between 2000 and 2007, and is predicted to step up pace to nearly 10% before 2012. The Brazilian National Health Vigilance Agency is Brazil's answer to the FDA and has enforced similar tight guidelines. These are viewed by some as overly stringent, and international investors now perceive that a fair proportion of time and money must be spent by new entrants wanting to succeed.

European entrants

Predicted to perform best over the coming years in Europe is France, which Global Markets Direct predicts will almost double its CAGR between now and 2012. But all EU nations must now comply with the amended Directive on Medical Devices and Active Implantable Medical Devices that was finalised in September 2007.

This revised legislation has laid emphasis on the clinical evaluation process as well as device safety requirements and post-production assessment of medical products. The impact on manufacturers, distributors and importers is being keenly felt.

In Spain, the number of patients undergoing medical implant operations has dramatically increased and as such its priority has been to develop an effective regulatory team to tackle the forthcoming challenges. For the same reasons, a strong emphasis on toxicology tests has also come to the fore.

"In addition to the time and money needed to navigate the UK's strict legislation, the field is dominated by multinational firms."

The prospects for the UK and German markets are more moderate than their Asian counterparts and France's flourishing sector. In addition to the time and money needed to navigate the UK's strict legislation, the field is dominated by multinational firms and new entrants find this a significant barrier to entry. In Germany, an ageing population is spurring on some growth but its field is largely dependent on trade with other European countries.

Although trailing the pack, Italy's future has been made that little bit brighter by two decrees implemented to form a new registration system in the country to enhance traceability. Domestic production accounts for 65% of all equipment used, which encourages a thriving local market but can put off international firms trying to get a foot in the door.

By having an understanding of these varying trends, manufacturing and distribution firms will have a greater chance of cashing in on this lucrative sector. But one theme globally is a greater regulatory emphasis on safety and traceability. Getting to grips with these will ultimately be the making – or undoing – of players in this market.

For the full report and further information visit http://www.global-market-research.net/.