Understanding the landscape: a strategic approach to registration in China. David Harrison VP QA RA Asia Pacific, Alere Inc.

Transcription

1 Understanding the landscape: a strategic approach to registration in China David Harrison VP QA RA Asia Pacific, Alere Inc.

2 cknowledgements to: Alere Inc: Jillianne Coles Samara Zhu Brandwood Biomedical: Dr Han Dehui

3 Registration is demanding. Why enter China? ING, March 15 Wang Bao an, Vice-Minister of Finance: nt althcare consumes 5.7% total govt. expenditure by Chinese counting standards. Approximately 12.5% by western standards. ditional spending on Health Reform : 2.2 T Yuan ($354 B) m essentially 0% in 2003, now 95% of population covered by blic health insurance with expenditure to date of 680 B Yuan. e

4 General Regulatory System and Levels of Regulations for Medical Devices and IVDs National People s Congress The State Council The Ministries National Laws or Acts Administrative Regulation Administrative Orders Regulation of Supervision and Administration of Medical Device Registration Labeling Classification Post-market Surveillance QMS auditing Standardization China Compulsory Certification

5 The Landscape NDRC National Development and Reform Commission ate Food and Drug Administration SFDA MOFCOM Ministry of Commerce try of Health MOH Relevant Authorities MOF Ministry of Finance China Inspection and Quarantine CIQ AQSIQ MOHRSS Ministry of Human Resource and Social Security

6 Life is a Rollercoaster. ING, March 10 (Xinhua) -- China plans to elevate the status of the ing State Food and Drug Administration to a general administration er to improve food and drug safety. roposed general administration will combine the functions of the ing State Council's Food Safety Office, the State Food and Drug inistration as well as the some supervision duties from the General inistration of Quality Supervision, Inspection and Quarantine

7 Regulatory Authorities of Product Quality & Market Access ulatory Authorities for duct quality & market access Regulatory Authorities for Market/Sales DA Product License for Market Bidding Policy & Pricing Control NDRC H SIQ IQ Product Surveillance & Recall Import License & Inspection Business in Medical Your Devices Business Government Procurement & Trade Policy HC Reform & Reimbursement Policy MOH MOF MOHRSS incial Company License of Intl Trade Policy MOFCOM

8 Regulations for Medical Devices and IVDs inistrative Regulation SFDA Orders ate Council Order No.276, effective April 1, Rules on Classification of Medical Devices (SFDA Order ) 2. Provisions on Medical Device Registration (SFDA Order ) 3. Provisions on Medical Device Manufacturing Supervision & Administration (SFDA Order ) 4. Provisions on Medical Device Distributor Licensure Administration (SFDA Order ) 5. Provisions on Medical Device Manufacturing

9 Regulations for Medical Devices and IVDs inistrative Regulation SFDA Orders and Decrees ate Council Order No.276, effective April 1, Provisions on Instruction for Use and Labeling of Medical Devices (SFDA Order ) 7. Provisions on Medical Device Standardization (Interim) (SFDA Order ) 8. Provisions on Clinical Trial of Medical Devices (SFDA Order ) 9. Provisions on IVD Registration (Interim) (SFDA Order ) 10. Administrative Provision for Adverse Event Surveillance and Reevaluation of Medical Devices (Interim) (SFDA Order ) 11. Good Manufacturing Practice of Medical Devices (Interim) (SFDA ) 12. Provision for Medical Device Recall (MOH Order )

10 edical Device Definition Intended to achieve purposes in: Prevention, diagnosis, treatment, monitoring or alleviation of diseases. Diagnosis, treatment, monitoring, alleviation or reparation of injuries or the handicapped. Research, replacement or modification of anatomy or certain

11 General Pathway to SFDA registration cal ion may nce ently Translation Registration Product Standard Type testing Clinical evidence or investigation in China Submission to SFDA SFDA Technical Evaluation SFDA Administrative Review & Approval Certificate Processing and issue IFU/Test Doc/Certificates SFDA authorized test centre Class II & III IVD reagents Validity for 4 years

12 General Pathway to SFDA registration weeks WDs riable) 0 WDs 5 WDs >9 months (usually longer) Translation Registration Product Standard Type testing Clinical evidence or investigation in China Submission to SFDA SFDA Technical Evaluation SFDA Administrative Review & Approval Certificate Processing and Issue

13 rerequisite for Registration Application of Medical Device Legal representative Agent for registration application After Sales Services Agent Product market approval in the country of manufacture Registration Application of IVD or Medical Device

14 nt in China IVD or Medical Device manufactured in a foreign country Wholly Foreign Owned Enterprise (WOFE) Joint-venture company China representative office of the foreign company Local Chinese company orized for legal

15 nt for registration application IVD or Medical Device manufactured in a foreign country Wholly Foreign Owned Enterprise (WOFE) Joint-venture company China representative office of the foreign company Local Chinese company orized to submit the

16 r Sales Services Agent Wholly Foreign Owned Enterprise (WOFE) Medical device manufactured in a foreign country Joint-venture company China representative office of the foreign company Local Chinese company orized to provide Product training Product maintenance and repair services Implementation of adverse event reports

17 uct market approval in the country of manufacture The country that has no normal approval process or system? Proof document from the competent authority

18 itionally Must have Chinese labelling EMC enforced from SFDA

19 ow to do it! in knowledge. E.g. The WMDO.org website training grams. n early! Prepare a comprehensive regulatory pathway n before investing any $$$. Or get an expert to do it for. ot direct in China, use expert agent(s). Don t rely on r distributor. Their motivations are not the same as rs. ster legitimate relationships. prepared, be thorough. The SFDA will scrutinize your dossier. approach the SFDA or Provincial FDA if clarification is needed. stuck, get a second opinion from another independent expert.

20 谢谢 Xiè-xie! (Thank you!)