1	AMDM ANNUAL MEETING APRIL 20, 2006 INTERNATIONAL UPDATE CHINA
2	AGENDA General Background Regulatory Environment Challenges Industry Activities Conclusion
3	I. General Background Fast Facts People’s Republic of China (PRC) Top legislative power – National People’s Congress (NPC) and its Standing Committee Top administrative body – State Council, the cabinet or chief administrative body of the PRC Administrative divisions – 23 provinces, 5 autonomous regions, 4 municipalities directly under central government. Plus the special administrative regions of Hong Kong and Macao. National Flag -
4	I. General Background (cont.) Same land mass area as the continental US The highest mountain in China is highest in the world – Mount Qomolangma More bird species than any other place in the world Population >1.3 billion (2004), 20% of world’s total density = 135 people/sq km (4x greater than US) Tremendous changes have taken place in life style in last 50 years – income, bank savings, consumption.
5	I. General Background Opportunities GDP is up 9.5% - over $1.65 trillion in 2004 Market growth of 15-20% per year 2^nd largest market in Asia, following Japan >30% of US exports go to China Healthcare system reform is underway Emerging wealth/urbanization WTO membership provides some leverage
6	II. Regulatory Environment
7	II. Regulatory Environment (cont.) A.2. Department of Medical Devices drafts relevant national standards drafts and revises professional standards and GMP supervises their implementation in charge of registration of medical devices monitors adverse events certifies clinical studies protocols, institutions, QS auditing of institutions manages advertising approval 3. Division of product registration approval of product registrations approval of clinical trials issues export certificates accepts applications and issues certificates
8	II. Regulatory Environment (cont.) 4. Division of Standards a. drafts and revises official standards b. formulates the list of material measuring products c. assesses qualifications of testing institutions d. organizes the management of medical device classification 5. Division of Safety Supervision a. drafts and revises medical device manufacturing certification, GMP, and supervises the implementation b. organizes the supervision and inspection of manufacturing sites c. assesses qualification of institutions evaluating GMP d. organizes monitoring of adverse events and product re-evaluation e. coordination and supervision within the department
9	II. Regulatory Environment (cont.) 6. Office of Acceptance of Medical Device Applications – takes charge of the approval, examination, and certification of domestic class III and all imported medical devices, advertising, issuance of export certificates.
10	II. Regulatory Environment (cont.) Regulations medical device registration, August 9, 2004 medical device – methods of supervision, DRAFT (5/25/05) recalls – DRAFT (11/1/05) adverse event reporting – DRAFT (~8/04) IVD registration – DRAFT (10/05) combination products – DRAFT (~9/05) medical device classification, February 17, 2000 clinical trials for medical devices, December 22, 2003 re-registration – DRAFT (5/2002) RoHS – due to go into effect July 1, 2006
11	III. Challenges Issues/Concerns type-testing clarity for classification of IVD’s event reporting times and processes recalls – definition, roles and responsibilities change control re-registration recognition of “test system” product standards recognition of QS certification BSE concerns RoHS pricing
12	III. Challenges (cont.) Overall concerns organizational disruption delay in release of regulations lack of transitional period redundant testing fear of government “pulling back” multi-agency involvement redundant/burdensome documentation requirements repetitive ISO audits RoHS – market availability pricing – market availability – new technology
13	IV. Industry Activities Industry Association Working Groups/Training diagnostic WG regulatory WG centralized tendering/pricing WG RoHS subgroup US China Healthcare Forum GMP Training Workshop
14	IV. Industry Activities (cont.) AdvaMed/US Department of Commerce JCCT – Co-chaired with SFDA Medical device task force subgroup meetings IVD workshops Planned AER and PMS workshop
15	IV. Industry Activities (cont.) APEC - Asia Pacific Economic Coordination – APEC leaders agree in principle to move toward a regional harmonization process amongst APEC economies with a view to achieving close collaboration, use of international standards, and global best practices through collaboration with bodies such as GHTF.
16	IV. Industry Activities (cont.) AHWP - Asia Harmonization Working Party – Countries work collaboratively with medical device regulatory authorities and industry organizations locally and regionally to study and recommend ways to harmonize regulations in the Asia region with global trends and work in coordination with GHTF and APEC.
17	V. Conclusion Websites/contacts www.sfda.gov.cn www.china.org.cn RoHS document draft – Steven Bipes, Program Manager, Regional and Bilateral Policy ANSI sbipes@ansi.org www.advamed.org info@advamed.org www.export.gov/china www.commerce.gov/china