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Working Towards Harmonization
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GHTF > Meetings and Training > Conferences >8th GHTF Conference - Ottawa, Canada 18-22 September 2000 > China Regulatory Procedures Meeting Information Session Brief

China Regulatory Procedures Meeting Information Session Brief

8th GHTF Conference - Ottawa, Canada

18-22 September 2000

China Regulatory Procedures Meeting
Information Session Brief

This brief is also available in Word and PDF format.

Title:	China Regulatory Procedures Meeting
Time:	Monday, 18 September 2:30 PM - 4:30 PM
Topic:	Top officials from the Medical Device Department of China's State Drug Administration (SDA) will provide an outline and update on the new medical device regulatory framework implemented in April 2000. The session offers industry representatives and regulatory officials a chance to hear firsthand about how the new Chinese regulatory system is working in practice, to learn about the SDA's plans for future regulatory developments, and to raise questions on topics of interest or concern regarding registration of medical devices for China's rapidly-growing market.
Proposed Agenda:	Co-Moderators' Introductory Remarks: Mr. Jeffrey Gren & Mr. Michael Baker Outline of China's Medical Device Regulatory Requirements: SDA officials Frequently-Asked Questions about the New Regulatory System: SDA officials State Drug Administration's Plans for Future Refinement of Regulations: SDA officials Audience Questions/Answer
Speakers:	Hao Heping, Director-General, Department of Medical Device Administration State Drug Administration of China 38A Bei Lishi Road, 100810, Beijing, People's Republic of China Tel: (86) 106-831-3344 / Fax: (86) 106-831-5648/5649
	Chang Yonghen, Dir., Foreign Product Registration Div., Dept. of Medical Device Admin. State Drug Administration of China 38A Bei Lishi Road, 100810, Beijing, People's Republic of China Tel: 86-106-831-3344 / Fax: 86-106-831-5648/5649
Co-moderators:	Jeffrey L. Gren, Dir., Office of Microelectronics, Medical Equipment & Instrumentation U.S. Department of Commerce ITA-Room 1015, 14th Street at Constitution Avenue, NW Washington, D.C. 20230 U.S.A. Tel: 1-202-482-2470 / Fax: 1-202-482-0975 / e-mail: Jeffrey_Gren@ita.doc.gov
	Michael Baker, Director-General EUCOMED Place St.Lambert, 14 B-1200 Brussels, Belgium Tel: 32-2-772-2212 or 32-2-775-9221 / Fax: 32-2-771-3909 e-mail: Michael.Baker@eucomed.be
Attachments:	Order #276 of the State Council of the People's Republic of China: "The Regulation and Supervision of Medical Devices (effective 1 April 2000) "Administrative [Management] Provisions on Registration of Medical Devices" "Categorized Rules on Medical Device Clinical Trial Reports" "Regulations for Medical Device Classification"

Updated 22 July 2004

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