Medical Device Administration in China

Sept.18, 2006Excel PharmaStudies Inc.

Competent/Administrative Authority

Competent authorities concerned:1, SFDA2, Center for Medical Device Evaluation3, Testing Authorities designated by the SFDA4, SFDA’s affiliates

Administration Scope of SFDA

Administration activities by the SFDA:1, Medical device registration, 2,Production, 3,Sales, and 4,Post-marketing surveillance

Legislation

Laws, regulations and provisions in medical device:1, Regulations for Supervision and Administration of Medical

Device2, Provisions for Supervision and Administration of Medical

Device Production3, Provisions for Administration of License for Medical Device

Dealer 4, Provisions for Administration of Medical Device Registration5, Provisions for Clinical Trial of Medical Device 6, Provisions for Administration of leaflet/insert sheet, Labeling

for Medical Device7, Provisions for Administration of Medical Device

Specifications/Standards8, Provisions for Medical Device Classification

Classification of Medical Device

For the purpose of medical device administration, medical device can be divided in three categories as below:

Class I medical device, it is with low risk and considered as safety and also only requires general controlClass II medical device, it has middle risk with relative safety and needs special controlClass III medical device, this kind of device is with high risk and requests highly special control

Note: Different categories of medical devices have different registration requirements and administrative treatment

Administration of Production of Medical Device

Medical device manufacturer must be with the followings:Medical Device Production Permit issued by SFDA’s provincial affiliates Business License issued by Bureau of BusinessLicense for Each Medical Device issued by the SFDA or its affilicatesCertificate for Quality Management System

Note: Medical Device Production Permit is valid for 5 years and should be renewed at the time of expiry date

Administration of sales of Medical Device

In China, Medical Device dealer must be with the followings:

License for Medical Device Dealer issued by SFDA or its

affiliates

Business License issued by Bureau of Business

Note:

1,The License for Medical Device Dealer is valid for 5 years and

should be renewed at the time of expiry date.

2, In the near future, the SFDA will enforce the Good

Distribution Practice for Medical Device distribution

Administration of Medical Device Registration-General

All medical devices must get pre-market approval called medical device license in China from the SFDA or its affiliates for the purpose of market in ChinaMedical Device License will be valid for 4 years and should be renewed six months before expiry date

Administration of Medical Device Registration-timeline

Class I: 85 workdays

Class II: 120 workdays plus time window of clinical trial

Class III: 150 workdays plus time window of clinical trial

Administration of Medical Device Registration-Cost for Import Medical Device

Investigator feeExcel’s service fee

Clinical Trial cost

Excel’s professional service fee for Regulatory Affairs: USD5,000-25,000

USD362USD362-3,620

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Application fee charged by the SFDA

Testing fee charged by testing authority

Application cost

Administration of Medical Device Registration-Procedure

Step I: based on product standard/specifications provided by sponsor Excel Compile product specifications in accordance with therequirements and format of SFDA

Step II: Get verification and approval on the product standard/specifications from testing authority

Step III: provide sample to testing authority for testing and get the testing report

Step IV: Conduct clinical trial if required and get clinical trial reportStep V: compile all the application dossier and submit the SFDA for

reviewStep VI: SFDA internally go the review procedure and issue the medical

device license

Administration of Medical Device Registration-Dossier Requirements for Import Medical Device

Application formQualification certificate of medical device manufacturerLetter of authorization to applicant agentPMA or 510KProduct Specifications following Chinese format and requirementsUse instruction or insert sheetTesting report issued by testing authorities qualified by the SFDAClinical trial reportGuarantee letter for the quality of productLetter of Authorization for sales agency in China and letter of promise and business licenseLetter of authorization for designated after-sales services agency in China and letter of promise and business license of the authorized agencySelf-declaration by the enterprise to guarantee the truthfulness of the documentation submitted

Excel’s Contribution

TranslationCompile product standard/specifications following Chinese format and requirementsHandling affairs associated with testingPrepare and submit application dossierFollow up and monitor review progressDeal with problems occurring during reviewGet license