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Medical Device Regulation between China and US

Tony Hussey & Mingzi Deng

1. Background - Rapid Developing China

In 2009, the sum of imports and exports

2347 billion USD

47% of GDP

2009 – 4984 billion USD

2010 – 5738 billion USD

Source: World Bank

2. Chinese Medical Device Industry Snapshot

2.1 The Current Medical Device Market

• 6.2 billion USD in 2005; annual 16 percent expanding (Osec Business Network Switzerland)

• 13.7 billion USD in 2006; 12.9% increasing (Espicom Business Intelligence)

• 6.6 billion USD in 2004; 7.3 billion USD in 2005; annual 9 percent increasing (NDRC)

2.2 Forecast and potential market (1)

• annual growth rate of the market in the period 2006-2011 is predicted to be 11.1% (Espicom Business Intelligence)

• Annual growth rate 9% (NDRC)

2.2 Forecast and potential market (2)

• Only meets approximately 60 percent of the demand (Osec Business Network Switzerland)

• Manufacturers ——19.5 percent increasing, from 356 in 1985 to 10,447 in 2004 (Osec Business Network Switzerland).

2.3 Where is the medical device industry located?

Circum-Bohai-Sea Region

Yangtze River Delta

Pearl River Delta

2.4 Where are the medical devices imported from?

3. Medical Devices Regulatory Authority in China and US

Comparison

4. The Comparison of Medical Device Definition

1. China - Medical used software

US - “General Principles of Software Validation” - Center for Devices and Radiological Health (CDRH)

2. China - “Product Classification Catalog of Medical Devices”

US - The U.S. Pharmacopoeia - database

3. China - Veterinary Department under the Ministry of Agriculture

US- “the other animals”

4. China - control of conception

US - none

5. The Differences of Medical Devices Administration System in China and US

“Federal Food, Drug, and Cosmetic Act (FD&CA)”, “Fair Packaging and Labeling Act”,“Medical Device Regulation Act”, “Food and Drug Administration Modernization Act”,“Medical Device User Fee and Modernization Act (MDUFMA).”

• Provisions on Classification of Medical Devices (No.15)• Provisions on Medical Device Registration (No. 16)• Provisions on New Medical Device Approval (Interim) (No. 17)• Provisions on Medical Device Manufacturing Supervision & Administration (No. 12)• Provisions on Medical Device Distributor Licensure Administration (No. 15)• Provisions on Medical Device Manufacturing Enterprise Quality System Inspection (No. 22)• Provisions on Single Use Sterile Medical Device Supervision & Administration (Interim) (No. 24)• Provisions on Instruction for Use and Labeling of Medical Devices (No. 10)• Provisions on Medical Device Standardization (No.31)• Provisions on Clinical Trial of Medical Devices (No.5)

Regulations on Supervision and Management to Medical Instruments (Decree of the State Council No. 276)

5.1 The Legal Status

5.2 The Administration Status

• National level - Provincial level - City and country levels

5.3 The Way On Dealing With Adverse Events

• FDA - Correction and Punishment

Recalling & Sending a warning letter

• SFDA - Punishment

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Chinese Medical Devices Industry

Challenges and opportunitiesJiafeng Tu, Mingzi Deng

Market Entry Requirement

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State Food and Drug Administration (SFDA) Registration

China Compulsory Certification (CCC)-Product safety, electrical interference and operator’s safety

Market Entry Requirement

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NO means NO PERMISSION

to market.

NO means NO IMPORTATION

into China.

About SFDA

• State Food and Drug Administration (SFDA)

founded in 2003, directly led by the State Council

of P. R. China;

• Local Agencies: 31 provincial-, 433

municipality-,1,936 county- level agencies (2,401

total);

• Technical Organizations: 16 state-, 122

provincial-, 373 municipality-, 436 county- level

organizations (947 total)

About

• Seven categories of electro-medical device products require CCC certification

• Electrocardiographs;• Hemodialysis equipment• Extracorporeal blood circuit for blood purification equipment;• Hollow fiber dialyzer;• Implantable cardiac pacemakers;• Medical x-ray diagnostic equipment;• Artificial heart-lung machine.

CCC mark certification requires a factory inspection by Chinese official at the applicant’s expense, as well as

follow-up inspections.

Regulatory agencies in ChinaThree Chinese agencies have regulatory roles for imported medical devices.

•State Food and Drug Administration (SFDA)Comprehensive system for medical device registration

•Ministry of Health (MOH)

•General Administration of Quality Supervision Inspection and Quarantine (AQSIQ) Maintains responsibility for certifying electrical safety for a wide variety of products

• Involvement of other agencies is required for specific devices

• i.e., Safety Quality Licensing Office for Import Boiler and Pressure Vessels (SQLO) certificates, China National Certification and Accreditation Admnistration (CNCA)*For more information about those agency ，

please see webpage or materials on blackboard.

Challenges in China

Laws and regulations are constantly changing

Limited official announcements

Much more Complex Relationships4

1

2

3

SFDA web in Chinese version

The SFDA website is using Chinese as official language.

ENGLISH

English?• Updated

monthly

• Simple Announcements

• Some translations of regulations provided (in “Chingling”)

Frustrated Industry

Which version of the standard?

• 二、对于产品标准采用或引用的国家标准或行业标准发生变化的，除因标准变化的内容对产品安全性、有效性有实质影响，国家食品药品监督管理局在发布、实施国家标准或行业标准的文件中另有规定外，在新标准实施之日前受理注册检测的产品，仍按照原标进行检测、审评和审批，但企业应当在取得医疗器械注册证后，自新标准实施之日起，按照新标准组织生产，在产品说明书、标准、标签、包装标识中仍标注批准注册时核准的产品标准编号。

• 2. Should changes occur to the national standards or industry standards for which the product standards are adopted from or referenced from, those medical devices which had received registration approval before the issuance of new standards shall be examined, reviewed and approved according to the original standards, except in situations whereby the safety and efficacy of the medical device would be substantially affected by the changed standards, and when other requirements already exist in regulations within SFDA- released and implemented national or industry standards.

• However, after the company has acquired the registration certificate and upon the validation of the new standards, the medical device should be manufactured according to the new version, and the product standard code of approval must be included in the product industries, labels and packaging of the product.

Laws and Regulations

• the fundamental law governing China’s health sector.• The regulations have been amended on several occasions by RED LETTERS

enacted in April 1, 2000

Amended Order 276Sep. 6, 2010

•Regulation on Supervision and Administration Medical Devices (Amendment Bill)•Consolidation of-Red Letters

-Clinical Trail, Manufacturing, Recall, and other regulations

•6 chapters, 48 articles 9 chapters, 88 articles

Order 276 --The Regulations for the Supervision and administration of Medical Devices

RED LETTER

Opportunity in ChinaMedical System Reform Drives RMB 16B Medical Device

InvestmentThe new medical and health system reform scheme was announced on April 6,

2009. According to this scheme, China will invest RMB 850 billion to promote medical and health system reform during 2009~2011. This big cake of new medical and health system reform has triggered competition between domestic and international medical device and medical software manufacturers.

Industrial income and profits of China medical device industry (unit: RMB100 million)

Source: State Statistic Bureau

Development OpportunityDuring 2003~2007, the annual growth rate of industrial sales revenues reached 27.08% and the annual growth rate of profit went up to 33.73%. In 2007, China had in total 298 private medical device enterprises, 240 foreign and Hong Kong, Macao and Taiwan invested enterprises, only 36 state-owned enterprises and 25 collective enterprises.

General situation of the Medical Device Export Market in China

By January 2010, China has exported medical devices to 186 countries and regions, with the exports amounting to US$ 1.0199751 billion. There were 19 countries and regions to which more than US $10 million was exported. The top ten export countries and regions accounted for 66% of the exports.

Source: State Statistic Bureau

China Medical RegulatoryOpportunities

• SFDA and CCC are recognized by the public.

• Competitive advantages

• Product classification

• Duty rates: MD vs. IT

Stay Informed, Compliant, Competitive …Stay Informed, Compliant, Competitive …

References• Ministry of Labor and Social Security: The Ministry of Labor and Social Security is in charge of making BHIS

formulary. http://www.gov.cn/english/2005-10/02/content_74185.htm• About the Center for Devices and Radiological Health. FDA.

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/default.htm. Accessed by Nov 23, 2010. • China Medical Devices Research Report. 2007. Access by Nov 23, 2010. • Espicom Business Intelligence (EBI). The Chinese medical device market: Facts and figures. China: Accessing the

Medical Device Market. July 2007 • National Development and Reform Commission (NDRC). The Research Proposal of Chinese Medical Device Market

and Price evaluation. 2005.• Osec Business Network Switzerland (OBNS). Market Report: Medical Device Market in China 2007.

http://www.osec.ch/internet/osec/de/home/export/publications/free.-ContentSlot-31391-ItemList-67490-File.File.pdf/BB_Marktstudie_Medical_Device_Market_in_China_070215.pdf. Access by Nov 23, 2010.

• Part 860. Code of Federal Regulations Title 21 (21CFR). FDA.• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=860. Accessed by Nov 23, 2010.• Regulations for the Supervision and Administration of Medical Devices. State Food and Drug Administration (SFDA).

P.R.China. Jan 4, 2000. • http://eng.sfda.gov.cn/cmsweb/webportal/W45649038/A48335998.html. Access by Nov 23, 2010. • Report on China's medical device market and investment. The Medical News. Sep 8, 2009• http://www.news-medical.net/news/20090908/Report-on-Chinas-medical-device-market-and-investment.aspx?page=2.

Access by Nov 23, 2010.• State Food and Drug Administration (SFDA). 医疗器械监督司 .• http://www.sfda.gov.cn/WS01/CL0187/ . Accessed by Nov 23, 2010. • The World Bank. 2009. http://data.worldbank.org/country/china. Accessed by Nov 23, 2010.

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Thank You!Mingzi Deng