Goals

1. To assure the safety and effectiveness of imported medical devices by assisting foreign manufacturers to comply with U.S. medical device regulations.
2. To direct U.S. firms to sources of information on foreign requirements for medical devices.
3. To support global harmonization activities

OHIP coordinates education for foreign governments and industry on the U.S. medical device regulatory process. This may involve seminars and presentations or arrangements for more in-depth learning experiences while at CDRH. OHIP and other CDRH offices participate in these activities.

During FY 2003, OHIP hosted 69 international visitors from 11 countries. The country and number of visitors are as follows:

• Canada (2)
• China (1)
• Germany (4)
• Israel (4)
• Japan (16) [including one 10-month training program with the Ministry of Health and Labour Welfare]
• Korea (6)
• Pakistan (1)
• Russia (15)
• Singapore (16)
• South Africa (3)
• Switzerland (1)

International Conferences

In addition to OHIP’s educational efforts for the domestic device industry, we also participate in international conferences to promote compliance with U.S. medical device regulations. During FY 2003, OHIP participated in 13 international industry professional conferences. Recent presentations include:

• Canada – Overview of MDUFMA; Overview of Medical Device Regulations;
• China – U.S. FDA Approach to Auditing; Role of Third Party Organizations;
• Embassy of Ireland – FDA Approach to Auditing; Guidance on Part 11, Electronic Records and Electronic Signatures;
• Germany – U.S. FDA approach to Auditing; Guidance on Part 11, Electronic Records and Electronic Signatures; Introduction to FDA Requirements & Terminology;
• Panama – Overview of the Medical Device Regulatory Program; Overview of the Global Harmonization Task Force;
• Russia – Overview of Medical Device Regulations; Overview of Quality Systems Regulations and Quality System Inspection Technique;
• South Korea – Overview of Quality Systems; Overview of Medical Device Regulations; U.S./EC Mutual Recognition Agreement;
• Singapore – Overview of Quality Systems;
• Switzerland – U.S. FDA Approach to Auditing; and,
• United States – Overview/update on U.S./EC MRA; CE Marking for the EU Medical Device Directives.

Global Harmonization

The Global Harmonization Task Force (GHTF) is comprised of government and industry representatives from the United States, Canada, the European Union, Japan, and Australia. Representatives from other countries also attend meetings and conferences, and participate in discussions of issues. GHTF members are working to build an international consensus on medical device regulatory policies and practices. The goal is to encourage convergence of worldwide medical device regulation to facilitate international trade, to promote technological innovation, and to enhance public health.

During FY 2003, OHIP:

• participated in monthly CDRH meetings to update the Center Director and coordinate activities;
• attended meetings of Study Group 4 on Regulatory Auditing of Quality Systems in Rockville, Maryland and Bern, Switzerland; and
• attended a meeting of Study Group 2 on Postmarket Vigilance in Lubeck, Germany.

U.S./European Mutual Recognition Agreement 

The United States and the European Commission (EC) have signed a mutual recognition agreement (MRA). The MRA covers a variety of “product sectors” that include telecomm unication equipment, electromagnetic compatibility (EMC), pharmaceutical good manufacturing practice (GMP), electrical safety, recreational craft, and medical devices.

The Medical Device Annex of the U.S./EC MRA provides for three types of regulatory activities: (1) the exchange of quality systems inspection/audit reports; (2) product evaluation reviews and/or testing for select low to medium-risk devices; and (3) establishing a program for exchanging information on serious health risks posed by medical devices.

OHIP leads CDRH’s implementation of the medical device annex of the MRA. In FY 2003, our accomplishments include:

• completed the Fourth Annual MRA report;
• confirmed that seven EU CABs meet the FDA criteria;
• provided classroom training in the FDA device regulations and inspection procedures and policies to EU CAB auditors;
• authorized four EU CABs to conduct independent inspections of EU device manufacturers on behalf of FDA;
• evaluated U.S. CAB dossiers and confirmed that seven U.S. CABs meet EU criteria;
• forwarded summaries of the dossier evaluations to the EC; and
• observed and evaluated one U.S. CAB auditing a U.S. manufacturer against EU device requirements.

Future work includes observing and evaluating the other U.S. CABs as they audit manufacturers; conducting on-site audits of U.S. CABs at their business sites; and continuing to train, evaluate and qualify EU CABs to conduct independent audits.