As most of you know, EDC (Export Development Canada) is an enterprise that works closely with TMTA.

 As part of this working relationship, the EDC’s Mexico office has just identified an opportunity for TMTA members to supply a  Mexican Private Clinic Group with 90 different products.

The Proeza Health Project is building a clinic in Monterrey as part of a pilot project which calls for 27 small medical centers to be erected across Mexico. Some of the services to be included in such clinics are:

·         Laboratory

·         Ultrasound

·         X-Rays

·         Mastografias

·         Image

EDC wants to know which TMTA members can help the Proeza Health Project with their requirements.
Responses can be directed through TMTA via an email to marcel@tmta.ca.

Over 4,000  exhibitors at the 40th Medica Fair

At the 40th anniversary of MEDICA, International Trade Fair with Congress, around 4,000 exhibitors from 70 nations will present their innovations on 1.2 million square feet of net exhibit space. A total of 700 of these companies are new exhibitors. MEDICA will take place from November 18 - 21, 2009 at the fairgrounds in Düsseldorf, Germany.

MEDICA bridges the gap between technical solutions and their application by combining the trade fair with integrated "theme parks" such as MEDICA MEDIA (Telemedicine/Medical IT, Hall 15), MEDICA VISION (Innovation Forum of the Research Institutes, Hall 3) and the Physiotherapy Forum (Hall 4) as well as with the MEDICA Congress (Congress Center South) and the 32nd German Hospital Conference. For the first time, the MEDICA Congress will include an international lecture series, with several presentations held in English. The Congress will cover a wide range of topics - from medical imaging and heart surgery to palliative medicine.

Exhibit categories at MEDICA 2009 will include the latest products for in-patient and out-patient care: electro medicine/medical device technology, laboratory equipment/diagnostics, physiotherapy/orthopedic technology, medical products (commodities and consumer goods), information and communication technology as well as textiles, medical furnishings, interior design and building management technology.

A hallmark of MEDICA is the high international attendance. Of the 137,000 visitors at MEDICA 2008, approximately 55,000 came from outside of Germany (from over 100 different countries). On the exhibitor side, 70% of the companies were from countries other than Germany. Visit their web site at www.mdna.com.

USA: Guidance on good importer practices
The FDA (Food and Drug Administration) and several other US government agencies have drafted a guide on good importer practices to help ensure that health products finding their way into the US meet required standards. The draft guidance recommends that importers consider instituting practices to identify and minimize risks associated with imported products. The draft guidance also recommends that, in general, importers should know the producer of the foreign products they purchase and any other manufacturers, such as trading companies or distributors, with which they do business. The FDA has been under pressure to strenghten the oversight of health products finding their way onto the US market following safety concerns surrounding health products imported from China India. The draft can be found under: Good Importer Practices - Draft Guidance.



Tanzania: Steps to establish a regulatory framework
The TFDA- Tanzanian Food and Drugs Authority has announced plans to establish a new regulatory framework for medical devices. Devices will be clasified according to the risk-based classification principles of the Global Harmonization Task Force and compulsory registration will be required for all products. The TFDA has framed guidance on evidence documents that companies would have to produce to register their devices. The agency is also seeking data of all imported products to control these devices during the transition period. Device importers have to submit all necessary information to the TFDA by 31 August.



EU: Guidance on clinical evaluation of stents
The European Commission issued the final guidance on the clinical evaluation of coronary stents, which describes the main requirements fort the clinical evaluation of this group of Class III medical devices. The guidance covers bare metal stents, drug-eluting stents and other innovative stents. The guidance is included as an Appendix to MEDDEV 2.7.1 on guidance to manufacturers and notified bodies on evaluation of clinical data. The document covers preclinical assessment, clinical investigation, evaluation of clinical data supporting CE marking, postmarket clinical follow-up and modifications to stents or indications for use. In terms of clinical investigation, the guidance recommends a minimum timeline for six months in general for bare metal stents and a minimum of 12 months for drug-eluting and other innovative stents. Each claim modification should be approved by the relevant notified body. The guidance can be download under: Guidance - evaluation on clinical data. 
 

China: New rules on adverse incident reporting
SFDA – China’s State Food and Drug Administration has issued interim rules that strengthen adverse event reporting requirements for medical device manufacturers, distributors, medical device users, technical institutions for medical device adverse monitoring, food and drug regulatory departments and other relevant authorities. The new rules also introduce the first-ever device re-evaluation procedures and came into effect on 30 December 2008. The SFDA is responsible for nationwide monitoring of adverse incidents and re-evaluation activities.

The regulation requires that manufacturers, distributors and medical end users establish an adverse event reporting system, which includes appointment of a responsible person for adverse incident reporting and management and the event records must be maintained for two years after the end of the product’s life-cycle. The regulation also specifies strict reporting timelines, f.ex. for an incident that has resulted in death manufacturer has to submit a special report within five business days.

Manufacturers of Class II and III (medium- to high-risk) devices must prepare a Medical Device Adverse Incident Annual Summary Report, which summarises adverse events in the previous year and submit to the relevant authorities (provincial technical evaluation agency) before the end of January each year. Under this regulation the Class III and imported devices are re-evaluated by the SFDA; Class I and II domestic devices are evaulated by provincial food and drug agencies .



Food and Drug Admin to become a more efficient and transparent operation
As previously reported in our Asia Medical eNewsletter, the Taiwan Food and Drug Administration (TFDA) will combine the Bureau of Food Safety, Bureau of Pharmaceutical Affairs, Bureau of Food and Drug Analysis, and Bureau of Controlled Drugs in order to better integrate the management of food and drug safety.

The TFDA will run a single-window operation to increase efficiency, decrease processing time, and improve transparency. In the future, instead of applying for medical equipment registration to different agencies depending on the type of device, medical device companies can send product information directly to the TFDA. Additionally, the TFDA will manage all import inspection, while routine inspections will be managed by the private sector.

The TFDA will also run a single-window operation for new drugs. Currently, new drugs are inspected by three institutions: the Bureau of Pharmaceutical Affairs, Center for Drug Evaluation (CDE), and the Bureau of Food and Drug Analysis. Once the TFDA is established, all data pertaining to new drugs can be submitted to the TFDA. The TFDA will then relay new drug technical data over to the CDE for further review. Companies will be permitted to request the status of the application at any point during the process. Deputy Minister Yan-Jen Sung states that this single-window approach will reduce the processing time from the current 230 days to less than 200 days.



DCC and DTAB approve new regulations for medical devices

In June 2009 the Drug Consultative Committee (DCC) and the Drug Technical Advisory Board (DTAB) approved new formal regulations for India’s medical device sector. The new regulations have been sent to the Ministry of Health for final notification, which is expected soon.

As of yet, India’s medical device sector has been largely unregulated. There is currently no specific definition for medical devices, and only certain devices are regulated as drugs by the Drug Controller General of India (DCGI). The new regulations will provide a specific definition for medial devices and create a formal category for medical devices separate from drugs. The DCGI will expand its medical devices wing to enforce stricter oversight on the import and manufacture of medical devices. In March 2009, the DCGI proposed 19 additions to the list of medical devices requiring registration. The number of additions is expected to expand to 49 new categories of medical devices with the new regulations.

The new regulations were devised by a task force consisting of trade bodies such as the Indian Chamber of Commerce and Industry and the Confederation of Indian Industry. The task force was advised by the World Health Organization, the United States Food and Drug Administration, industry experts, and public opinion.

 

Strong ratings for healthcare companies
Medical device companies got a clean bill of health from Standard & Poor’s, but they’ll soon require a follow-up appointment. The good news from S&P’s Rating Services is that, so far in 2009, it has upgraded nearly double the amount of healthcare companies that it has downgraded.

The industry report, “North American Health Care Companies Remain Vital, But Require Observation,” says that essential medical products and services are continuing to pump up healthcare companies. However, it notes that a changing political landscape and slumping economy pose many risks to the industry.

Medical device makers St. Jude Medical and Covidien are among the strongest performers of 2009, an article in the Wall Street Journal says.

Brazil’s economy and healthcare system have been undergoing major transformations in the last decade. As a result, the Brazilian government is now allocating more funds for retro-fitting all of the country’s hospitals. This move is resulting in a substantial increase in purchases of new technologies. Since Brazil has few in-country medical products manufacturers, the situation offers great potential for Canadian manufacturers to increase exports and boost sales. 

A ground-breaking mission
Canadian companies can benefit greatly by getting in on the action as soon as possible. As with all new markets, firms that benefit the most will those who get in on the ground floor. TMTA’s strategy has been to align itself with ABIMO (Brazil’s national medical and dental device association) and Canada’s consulate in Sao Paulo to launch “Brazil 2009”, TMTA’s first medical technology mission to South America. As of today, registrations is open to all Canadian Companies interested in doing business in this major emerging market. 

The Mission took place from June 1 to June 5 and coincided with Hospitalar 2009, Brazil and South America’s largest medical device show. The visit featured "one-on-one" meetings with potential distributors and a session devoted to walking the floor of the Hospitalar Exhibition in Sao Paolo. Participating companies had the opportunity to have a first hand look at the type of products in use by Brazilian hospitals and explore specific markets for Canadian manufacturers.

The Mission included meetings with public and private healthcare administrators and visits to a public and a private hospital to examine the type of technology used in the Brazilian healthcare system. There will also be presentations from experts on Brazilian regulations and meetings with Brazilian Government officials to explore the government’s ambitious plan to substantially improve Brazil’s healthcare delivery system.

Get in on the action now
Four TMTA member companies were part of the 2009 mission. Other companies wishing to be in on the action in 2010 should contact us right away as participation will be limited to a group of no more than 10 companies in order to make the mission more manageable. Some financial assistance may be available from Foreign Affairs to defray certain costs but details await a confirmation from Foreign Affairs.

Consider entering the Brazil market. Not only will your firm be among the first to explore medical  technologies used in Brazilian hospitals, you will also have a big say in shaping the future of Canada’s trade with Brazil and be among the first to reap its benefits. One of the goal of the mission is to is to advise Canadian manufacturers on what markets to target in order to achieve sales and increase exports to Brazil, accumulating practical, useable market intelligence for the medical technology industry.

To register or enquire about details, drop us an email at marcel@tmta.ca Since this mission enjoys the support of medical technology associations across Canada, companies outside Ontario can contact their provincial association.

Keep checking this page for updates. Reports on the 2009 mission will be posted here as soon as they are available.

BioPharm America™ is the place to meet with AstraZeneca, Bayer Schering, Exelixis, Genentech, Gilead, Johnson & Johnson, Merck & Co., Inc., Pfizer, Takeda, UCB and many more pharma and large-cap biotech companies hunting for deals.

As a participant of BioPharm America you will benefit from partneringONE™, the industry partnering platform, to screen hundreds of potential partners and easily schedule pre-arranged meetings. 

Three easy steps to be part of the action:

1.     Register
2.     Browse a large pool of licensing opportunities and identify potential partners
3.     Pre-arrange private one-to-one meetings

Conference links:

* View the Preliminary BioPharm America Program
* View the list of Presenting Companies to date
* View the BioPharm America 2009 Sponsors
* View the pre-conference program: ChinaBio Day 2009

To register: Martina Rannertshauser, EBD Group
mrannertshauser@ebdgroup.com

Medical Device Product Liability and Serious Derivative Risks
Arising from Miscommunications and Failure to Warn Seminar

Product Liability Seminar
September 10, 2009
Morgan Lewis Offices
Philadelphia, PA

Medical device companies do their utmost to design and manufacture products that are safe and effective for their intended therapeutic purposes, and through appropriate labeling, instructions, and training try to guarantee that they are used in the right way.  But in an imperfect world, things do happen, and too often they result from inaccurate, inconsistent, or improper communications, misunderstandings on the part of the users, or representations made outside of the manufacturer's control.  Such problems, when linked to patient adverse events, can result in "failure to warn" product liability actions that are potentially devastating to companies.

In this unique conference, experts from law firms, the medical technology industry, and the insurance field review the medical device product liability landscape, present and emerging legal trends, areas of greatest potential risk, and best practices for companies to monitor and assess the myriad representations made about their products.

Speakers include:
John P. Lavelle, Jr., Partner, Morgan Lewis
Brian W. Shaffer, Partner, Morgan Lewis
Marta L. Villarraga, Ph.D., Exponent Medical Device & BioEngineering
Sara Dyson, Loss Control Manager, Medmarc Insurance Group
Joseph Coray, AVPt, Technology Practice Group, The Hartford
Kenneth Ross, Counsel, Bowman and Brooke
M. Elizabeth Bierman, Partner, Morgan Lewis
Kathleen McDermott, Partner, Morgan Lewis
Additional Speakers TBA

General Information:

This seminar will take place at the Philadelphia offices of Morgan Lewis, located at:
1701 Market Street
Philadelphia, PA
215-963-5000 - phone

Please be advised that there are no hotel room blocks associated with this seminar.