Medical Device Regulations Draft: MEPs Propose more than 900 Amendments

Medical Device Regulations Draft - MEPs Propose more than 900 AmendmentsJune 12, 2013 – The new medical device regulations might change significantly from the original draft report proposed by the European Commission or the version introduced by Rapporteur Dagmar Roth-Behrendt. This became clear as the Committee on the Environment, Public Health and Food Safety (ENVI) debated the device regulations and MEPs added their amendments to the regulations last month. Not only were there more than 900 amendments; there were also several different amendments to the same clauses in some cases, according to life science lawyer Erik Vollebregt. In addition, Roth-Behrendt and IVD regulation Propel Rapporteur Peter Liese added amendments to each other’s proposals. It seems that the only thing everyone can agree on is that there needs to be more oversight over notified bodies.

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Medtech Summit in Shanghai Touts Fertile Investment Opportunities

June 13, 2012 – The 2012 China Medical Device Industry Development and Investment CEO Summit held on 9 June 2012 in Shanghai brought together various stakeholders including government officials, medical device manufacturers and investors to discuss the state of the industry and further promote its development. CMDM Associate Editor Helen Zhang was in attendance and shares some of the highlights.

Pudong, the district of Shanghai that sprouted across from the Bund in the 1990s, is home to a burgeoning biomedical industry. More than 500 life-science companies, generating revenue of RMB 28.4 billion (€3.5 billion), are located there. In 2011, the medical device industry in the Pudong district grew by 46%.

Domestic national growth won’t reach those stratospheric heights, but it is doing quite well, nonetheless. Propelled by increased urbanisation, an ageing population, growing public awareness of healthcare issues, rising consumer spending and government support, the medical device industry is forecast to grow at a 20% compound annual growth rate for years to come, according to Chen Kaixian, Chairman of the Shanghai Science and Technology Association.

Multinational corporations control the lion’ s share of the market, noted Hua Yutao, director of China Biology Technology Development Center. Seventy percent of high-end medical devices are imported. Only about 2000 companies in China produce Class III devices.

The cardiovascular sector will achieve annual growth of 19% and be valued at RMB 420 billion (€53 billion) by 2016, according to Liu Dao Zhi, Senior Vice President, Emerging Business, Microport Shanghai Co., Ltd. In 2011, 332,992 percutaneous coronary therapy (PCT) procedures were carried out and 42,986 pacemakers were implanted in China, he added. Zhang Ruiyan, director of the Department of Cardiology in Shanghai Ruijin Hospital, noted that the comparatively high rate of cardiovascular disease will continue to increase as the population ages. PCT and minimally invasive surgery will become the mainstream technologies in this field. Noted Hu Xubo, Partner, Qiming Ventures: “It’s the ideal time to invest . . . at present, there are no leading investor brands in cardiology. We predict that special-purpose funds will do well. Over the next five years, there are more opportunities than risks.”

Another sector showing tremendous promise is medical imaging. The annual compound growth rate is forecast to surpass 15% over the next five years. Ma Qiyuan, CEO, Time Medical: “The 12th five-year plan stipulates that there are 7100 hospitals at the county level in China, only 800 of which have MRI equipment. Japan has 36 installations per million population, the United State has 31, and China only has 2.5,” said Ma Qiyua. The imaging sector faces a historic opportunity. “In five to 10 years, leading companies in China will be able to compete with foreign players,” predicted Xia Fenghua, President, Shanghai Siemens Medical Device Co., Ltd.
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Norbert Sparrow
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UK Pip Implant Report Calls for Improvements to MHRA, EU Device Regulations

May 15, 2012 – The UK Health Minister Lord Howe has published a report looking into the actions of the Medicines and Healthcare Products Regulatory Authority (MHRA) relating to the Poly Implant Prothèse (Pip) implant scandal.

The report found that the agency started to receive reports related to the Pip implant scandal as early as 2002. In 2006, surgeons contacted the agency, concerned that the implants were breaking more frequently than other brands. MHRA brought these concerns to the attention of the notified body TUV Rheinland, which was responsible for assessing the implants, and continued to analyse Pip incident data afterwards. Ultimately, the blame “lies squarely with the fraudulent manufacturer”, the report found.

While the review found that the MHRA acted reasonably, it also calls for several improvements to the agency. MHRA needs to improve its procedures for gathering evidence related to device safety and analysing reported problems, according to the report. It also needs to find better ways of communicating with the public. In addition, the report calls for changes to the European regulatory system, stating that EU countries must work more closely together and become better at sharing information on medical devices.

However, the report rejects the need for a premarket authorisation system, something the European Parliament called for in its Pip resolution. “Nothing about this case provides evidence to suggest the system for regulating medical devices is fundamentally unsound and that there needs to be a shift to a system like that used to regulate pharmaceuticals in the EU, or the system used to regulate higher risk devices in the United States…Putting in place even the most exhaustive testing regime before market authorisation would not have prevented this deliberate fraud taking place once the product was on the market,” the report says.
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Camilla Anderson
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