INTERNATIONAL

The international section of MDMA's website is sponsored by Underwriters Laboratories Inc.

Click here to view upcoming international events.


News


Upcoming Commercial Service Initiatives

As part of MDMA’s ongoing interaction with the Department of Commerce, below please find a link to upcoming international opportunities for your company.

Upcoming Schedule of Events

 

If you have any questions about these initiatives, please contact your local U.S. Commercial Service trade specialist. To find the trade specialist nearest you please visit http://www.buyusa.gov/home/us.html.



Under Secretary for International Trade Christopher A. Padilla to Lead a Health-Care Trade Mission to China
April 24 -25, 2008
Beijing, China

China is preparing to unveil new health-care reforms that could have a significant impact on the market in China for medical devices, healthcare services, and pharmaceuticals. In an effort to understand the direction of these reforms, and to maximize opportunities for U.S. suppliers, Under Secretary of Commerce Christopher A. Padilla will lead a Health-Care Policy Trade Mission to China, April 23-25, 2008. The mission will focus on a broad range of health-care sectors and provide a timely opportunity for U.S. executives to meet with key officials in China’s health-related ministries to discuss the direction and structure of the upcoming health-care reforms. Participation is open to 15 qualified U.S. companies
More information


Registration Dossier Basic Requirement Opinion Request Notice for
3 Types Medical Device
Danny Chen, ChinaGate partnering with Underwriters Laboratories

December 14th -- SFDA published a notice on their website to request comments for draft guidelines regarding registration dossier basic requirement on the following 3 medical device categories:
1. Medical Device Containing Drug Ingredients
2. Medical Device Containing Animal Materials
3. Non-Electric Implant Medical Device

Compared with the previous regulations, the key points in the draft guideline are:

  • For medical device containing a drug ingredient, detailed information on the source of the drug ingredient, dosage rationale, CMC data, pharmacology data, toxicology data, etc. are required for SFDA review.
  • For imported medical devices containing an animal material, more safety information on the source of the material, virus contamination, risk analysis during production, verification on virus deactivation, etc are required.
  • For non-electric implant medical device, information on production rationale, product shelf life, manufacturing process, sterilization, etc. are required.

The deadline of feedback is set on March, 2008.

From these new draft guidelines and the newly launched IVD regulation on registration and clinical requirements, it is very obvious that the SFDA now is paying more and more attention on medical device regulation development. We expect in the near future, SFDA will set up a complete regulation system on medical device management in China.

 

Australia and Canada today signed a Memorandum of Understanding (MoU) recognising each other’s assessments of new medical devices
June 1, 2007 --The Parliamentary Secretary to the Minister for Health and Ageing, Senator Brett Mason, and the High Commissioner for Canada, Mr Michael Leir, signed the MoU on Quality Management System Certification for Medical Devices. It follows the signing of a Mutual Recognition Agreement (MRA) between Australia and Canada in May 2004 that enables each country to accept the other’s Good Manufacturing Practice (GMP) audits and inspection of the makers of prescription and over-the-counter medicines.

The MoU will enable Health Canada to recognise Quality Management System certifications issued by Australia’s Therapeutic Goods Administration (TGA) for Australian and New Zealand manufacturers exporting to Canada, and for the TGA to recognise QMS certifications issued by Canadian Registrars (auditing bodies) for Canadian manufacturers exporting to Australia and New Zealand.
Read More...

 

New Regulations in China re-classify In-Vitro Diagnostic Devices
Janice Ma, ChinaGate
April 3, 2007-- The Measures for the Administration of In-Vitro Diagnosis Reagents Registration (Interim) was approved by the State Food and Drug Administration (SFDA) of the People’s Republic of China. These new regulations effective June 1, 2007, change the classification of IVD devices from biological to medical. As of June 1, 2007, the previous notice on the Implementation of Classification of In-vitro Diagnostic Reagents (Guo Yao Jian Ban (2002) No. 324) and other provisions on the categorization of in-vitro diagnostic reagents have been annulled.

To guide the clinical research on in-vitro diagnostic reagents and the composing of label and insert, SFDA formulated the Technical Guidance for Clinical Research on In-vitro Diagnostic Reagents and the Guidance for Composing insert and label of In-vitro Diagnostic Reagents. This Technical Guidance will also be implemented at the same time.


Pharmaceutical Affairs Law (PAL) Japanese Good Manufacturing Practice (JGMP) transition period ends 1 April 2007
March 23, 2007-- When Pharmaceutical Affairs Law (PAL) became effective on 1 April 2005, some of the provisions related to productions controls (so called Japanese Good Manufacturing Practice (JGMP) or Ministerial Ordinance 169) were excluded for a period of 2 years. This includes requirements such as management responsibility, risk management in production, design controls (if applicable), criteria for suppliers, process validation and analysis of data. Manufacturers using ISO 13485:2003 will already have most of these controls in place. However, it is possible that earlier JGMP audit reports showing the exclusions could inadvertently be used in new applications. From April 1, care should be taken that any new applications for product certification or approval include JGMP documentation covering all applicable requirements for the device.Read more...

Understanding Japan’s Medical Device Certification System
Steve McRoberts, Seiko Ohyama, and Tara Kambeitz
Underwriters Laboratories Inc.
Read more...



UL Medical Business Unit First to Launch ISO 14971 Registration
March 13, 2007 -- Northbrook, Ill., Underwriters Laboratories Inc. (UL), a world leader in product safety testing and certification and management system registrations, today unveiled a first-of-its-kind service for the medical device industry that streamlines the regulatory compliance assessment process for manufacturers seeking global market access efficiencies.

UL is the first compliance and regulatory service provider to offer a registration service to ISO 14971. As first to market with this service, UL continues to support our position as an end-to-end regulatory solutions provider and industry leader, with the vision to help the Medical Device industry achieve business advantage.
Read more...

EU adopts IEC 60601-1:2005 - 3rd Edition - November 30, 2006
March 7, 2007--Although IEC 60601-1:2005 standard was officially adopted by CEN as a European Norm on 30 November 2006, the standard has not yet been published in the official journal of the European Union as a harmonized standard for the Medical Devices Directive 93/42/EEC.
Read more...

Bulgaria and Romania Join the European Union
January 1, 2007, Bulgaria and Romania were accessed to the European Union. With these additions, the EU now has a total of 27 member countries and contains over 500 million people. Medical Device Manufacturers shipping products into Bulgaria and Romania will now be required to comply with the EU Directives for Medical Devices (MDD), In-Vitro Diagnostics (IVDD), and Active Implantable Medical Devices (AIMDD).
Read more...

Medical Device Industry Representatives Testify Before ITC
July 11, 2006 -- Representatives from the medical device industry testified before the U.S. International Trade Commission in Washington, DC. MDMA has been meeting with ITC representatives and engaging in dialogue regarding market conditions for medical device companies in Japan. Since its creation in April of 2004, the new agency in charge of device approval in Japan, the Pharmaceuticals and Medical Devices Agency, has created numerous barriers for the industry. Most prominent, the new Pharmaceutical Affairs Law, enacted in April of 2005, has greatly disadvantaged firms as they have had to completely overhaul their regulatory processes and procedures. Through continuing dialogue and raising the awareness of agencies and lawmakers in the U.S. and Japan, MDMA hopes to facilitate changes that will provide greater market access for firms that have up until now, been unable to enter the Japanese market.

Germany's New DRG Reform Legislation
October 2004 -- German health officials met with MDMA International Advisor, Ed Rozynski in Washington, DC in late October and confirmed that the new DRG reform legislation is basically complete now that it has cleared the first Bundestag and it will be reviewed by the Bundesrat, the upper house, in November for implementation in January. The new legislation extends the DRG phase-in period for one year to 2008. A working group of the arbitration committee for the two houses of the German parliament is currently meeting to work out the remaining issues in the DRG legislation for 2005. If successful, the new legislation may reimburse hospitals for high-tech medical device procedures undertaken both retrospectively and prospectively.
Read more...


New Japanese Pricing Rules Take Effect April 1, 2004
Ed Rozynski, MDMA's International Advisor has translated into English the first complete version of the Japanese government's pricing rules which take effect April 1st, as well as nine different application forms that are needed to apply for coverage and reimbursement in Japan.  The updated rules explain how products are classified for reimbursement and the process for securing coverage and reimbursement, including the rules for obtaining a premium price for a new product; and for the government's adjustment of prices during the Japanese health ministry's biennial price revisions.
Read more...


MDMA Supports Repatriation Legislation
Repatriation legislation - originally included in the Homeland Investment Act (H.R 767/S. 596) earlier this year – would provide a temporary one-year reduction in the tax rate on above average repatriated earnings of U.S. foreign subsidiaries. This rate would be reduced to 5.25% from the current 35%. The legislation is designed to provide stimulus to business spending and the overall U.S. economy.

Today, Dr. Allen Sinai of Decision Economics, Inc. released a report on the positive effects repatriation legislation would have on the U.S. economy. The report predicts growth in the GDP, a boost in capital spending, creation of approximately 129,000 new jobs per year, and a $12 billion increase in tax revenues per year.

MDMA supports efforts on Capitol Hill to pass repatriation legislation, which we believe would have a positive effect on the U.S. economy by creating jobs, stimulating increased tax revenues, and allowing companies to reinvest their revenues domestically.  For more information, see:
The Sinai Report
JP Morgan Status Report

China: A Great Market for U.S. Medical Devices (PDF)
Hospitals in China enjoy a high degree of purchasing power and discretion. They are keen to buy high-quality and technologically advanced products from U.S. manufacturers. The United States already exports over $500 million worth of medical devices a year to China and Hong Kong.
Read More...

New Japanese Bundled Payment System
In Japan, industry has been speculating for months about the new DRG or, rather, DPC (Diagnostic Procedure Combination) system that Japanese health officials will launch in its 82 leading hospitals (i.e., Japan’s 80 university hospitals, its National Cancer Center, and its National Cardiovascular Center) starting on April 1.
Read more...

Looking Overseas? Understand the Market that You Want to Sell Into
While the U.S. market for medical technology is by far the largest market measuring $75 billion, there are many large, rapidly growing and profitable markets overseas. Nearly $3 billion in U.S. medical device exports are shipped to Japan to help support the huge $25 billion market there. The EU accounts for $45 billion in annual medical device sales with nearly $6 billion being purchased and exported directly from the United States. The $15 billion German market is the largest market in Europe by a 2-to1 margin but the France, Italy the UK and Spain are also large and potentially attractive markets for your products.
Read More...

U.S. Chamber of Commerce Launches U.S.-Singapore Partnership Program
The U.S. Chamber of Commerce launched the U.S.-Singapore Business Partnership Program at a press conference on March 15, 2002. The Strategic International business development program, funded by the Government of the Republic of Singapore, was officially announced and endorsed during the APEC Small and Med-sized Enterprises (SME) Ministerial meeting in September 2001.
Read More...

      

Links and Resources

www.key-technologies-in-bavaria.com Key Technologies in Bavaria:
Information on 10,400 Bavarian enterprises, research institutions, economic organizations and government institutions