Asia Market Access

While Asia contains a majority of the world’s population, it currently represents just 15% of the global health care expenditure. In addition, countries such as Japan and China face an aging population with the need to manage chronic conditions such as diabetes, cancer, obesity and cardiovascular disease.*

With 2008 health care expenditures of nearly $800 billion USD, Asian countries are spending on technologies that improve care and reduce cost of care. LNE provides independent certification to verify the reliability and safety of your products, so you can access this important market.*

Access to the Japanese market

LNE/G-MED can certify quality management systems of manufacturers of medical devices, including Electro-Medical and In Vitro Diagnostic Devices for sale in Japan. LNE/G-MED has established partnerships with leading Registered Certification Bodies (RCB) to meet Japan's requirements for audit under J-PAL regulations.

By working with LNE/G-MED America, you get the benefit of local auditors and project management contacts, while meeting the necessary requirements to have qualified entities in Japan oversee the process.

Access to the Taiwanese Market

Under Taiwan’s medical device regulations, manufacturers are required to set up an organization that complies with the Good Manufacturing Practice (GMP) code. Certification to standard ISO 13485 is recognized as equivalent to GMP. Taiwan’s Department of Health has set up a technical cooperation program (TCP Program) under which foreign certification bodies are recognized for certification of European production sites.

LNE/G-MED has been accredited under this program since November 2004. In order for a local distributor to obtain a license, LNE/G-MED offers European manufacturers the appropriate audit report and attachments. North American manufacturer must obtain a free sale certificate from their regulatory authority.

Advantages

As your partner, LNE/G-MED America is committed to helping you understand the regulations and considerations for offering your products in Asia. In addition, we offer excellent value and unmatched service, including:

• Local Washington, DC based office with qualified auditors throughout North America to increase convenience and minimize travel costs
• Simultaneous certification for CE Marking, Quality Management Systems (ISO 9001, ISO 13485) and other standards often performed by a single, highly-qualified auditor, to save you time and expense
• Widely recognized LNE/G-MED expertise as a European Notified Body (CE 0459), as an Accredited Certification Organization by France's accreditation body COFRAC, as a Registrar accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and recognized by Health Canada and as a Third Party Accredited Person by the U.S. FDA and by Taiwan’s Ministry of Health for audits to standard ISO 13485
• Added services, such as product testing (EMC, electrical, mechanical, CB Scheme), product certification, pre-assessment audits and fast-track or onsite review for CE Marking

Find Out More

LNE/G-MED America offers in-person, online and other customized training on a wide range of certification and quality topics. For details, check out our training schedule or request a customized program.

 

Contact LNE/G-MED America

• For proposals or other service questions: contact customer service
• Ask our experts to submit specific questions to our technical team

 

*Source: Asian Hospital & Healthcare Management, 1/12/10 online