Tips to Taiwan Medical Device Regulation

Transcription

1 Tips to Taiwan Medical Device Regulation 15 th March, 2017 Rachel Tserng Qualification in Biotechnology and Business Bilingual in English and Mandarin Experience in preparation and management of regulatory filling in Australia and Taiwan Network and professional relationships with regulators and industry in the Asia Pacific.

2 : Medical Devices and IVDs Technical and Regulatory Global Perspective Highly Networked Highly Engaged

3 TAIWAN Market Population 23.5 million Market size > US $3.5 billion (2015) Projected growth 7.7% ( ) One of Asia s most advanced markets Over 70% of high end devices imported US contributes over 30%.

4 Demographics 13% > 65 Sophisticated Market Demand for the latest technology Delivery Most care as public patients Opportunity!

5 Agency and Legislation

6 Taiwan Food and Drug Administration (TFDA) Food Drugs Medical Devices Cosmetics Management system reformed Medical devices registration TFDA established under Department of Heath DOH elevated to Ministry of Health and Welfare (MOHW)

7 Pharmaceutical Affairs Act 2015 Regulation for Registration and Management of Medical Devices Guidance for Medical Device labelling, post market activities and product specific preclinical guidance

8 Taiwan Regulation Key Points

9 Taiwan Regulation Must haves MUST have country of origin approval Required to have predicate in Taiwan Valid GMP/QSD Certification MUST have local Taiwan sponsor Focus on safety and efficacy of device

10 Common Documents Chinese and English labelling materials QSD Certificate Pre-clinical & Quality testing reports Product information Clinical Evidence Report (for high risk) Authorization letter from legal manufacture to local agent Sponsor Business license For Class III Devices: Technical Documentation in STED format

11 Quality Systems Documentation (QSD)

12 3 Paths to QSD Certification Abridged pathway for US manufacturers Establishment Inspection Reports (EIRs) by FDA Certificate to Foreign Government by FDA (CFG) ISO certificate* Abridged pathway for EU manufacturers (including Switzerland & Lichtenstein) Inspection Reports by European NBs Free Sale Certificate ISO certificate Standard Pathway ISO certificate Full Quality manual, quality procedure & manufacturing flow chart *May be replaced with a US CFG which shows compliance with current GMP

13 Application QSD Overview Obtain QSD certificate before registration Renewal Certificate valid for 3 years Renewal filed 6 months before expiry Timeline 120 calendar days Exempt Class I non-sterile & non-measuring

14 QSD reviewing process Pass to 3 rd party for technical review 3 rd party review 30 days Review Questions ~120 days (indicative) 60 days Respond to Review Questions TFDA issues final decision to sponsor/ manufacturer Pass the submission with decision to TFDA 3 rd party review 30 days

15 General Manufacturing Process Flow Quality System Processes Plant #1 Plant #2 Plant #3 Plant #4 Sterilization Vendor Design Control Product A Product B Product B Manufacturing Testing Packaging Testing Boxing/Labeling Sterilization Testing Release Medical Products Quality System

16 QSD Certificate Manufacturer Facility Critical step of manufacturing process Typically at Quality Control final release manufacturer facility QSD manufacturer facility will be linked to Product Registration Labelling and IFU Registration certificate

17 Product Registration Process

18 Classification II III I Classification Risk level Submission documents Class I Low Declaration statement only Class II Moderate Technical data Class III High Technical file in STED format

19 Reviewing Timeline - Class II Application submitted to TFDA. Each application takes average of 2 weeks to allocate to a reviewer. Applicant has approx. 60 days to respond to TFDA TFDA Issue Formal Review questions to the applicant. Applicant submits response to the review questions to TFDA TFDA has 75 calendar days to review TFDA has 65 calendar days to finalize application

20 Reviewing Timeline - Class III Application submitted to TFDA. Each application takes average of 2 weeks to allocate to a reviewer. Applicant has approx. 60 days to respond to TFDA TFDA Issue Formal Review questions to the applicant. Applicant submits response to the review questions to TFDA TFDA has 105 calendar days to review TFDA has 95 calendar days to finalize application

21 Pre-market submission documents Class I Class II Class III New design, structure, material or combination Self-declaration Common Documents plus GMP/QSD Manufacturer must hold preclinical and QC testing on file Labelling must comply with requirements. Technical File (clinical report may be required) US and CE approved: exempted from preclinical and QC testing reports STED (including clinical report) Essential Principle (EP) Checklist Technical File (including clinical report)

22 Class II: US and EU approvals allow exemption from pre-clinical and QC testing reports FDA certificate EC certificate

23 Class III GHTF STED format is mandatory

24 GHTF Technical File (STED) Format Device description & Product Specification Essential Principle (EP) checklist Risk analysis and control summary Design and Manufacturing Information Product verification and validation Labelling Clinical Evidence

25 Clinical Trials International Data Taiwan Accepts International Data, subject to: Compliance with GCP equivalent to Taiwan GCP (all advanced jurisdictions) Applicability of data to Taiwan usage Ethnicity, genetics, clinical practices, demographics, cultural factors Local or regional differences in indication will need to be supported by local trials Note that in practice, East Asian data may be judged equivalent for purposes of genetics/ethnicity Guidances: Q&A for handling of clinical trial results on medical devices obtained in foreign counties. Administrative Notice 23 June 2006 Handling of clinical study data on medical devices which was carried out in foreign countries PFSB/MDE Notification No March 2006 Handling of the data of clinical studies for medical devices conducted in foreign countries PAB/MHW Notification NO March 1997.

26 Labelling IFU Must be bold in black or marked in red box Warning statement Contra-indication Precaution Side effect Manufacturer and sponsor information Chinese product name must not include any letter, number, or symbol Model numbers and specifications

27 Summary of Device Registration in Taiwan Documents I II III Country of Origin Approval Preclinical testing * QC Testing * Clinical Evaluation Report (In-Taiwan Clinical trials not normally required) * Technical file in STED format Administrative Documents *Not normally required if CE & FDA approved BUT may be requested during review

28 Certificate renewal

29 Re-registration submissions Product Registration 5 years of validity Re-registration shall be submitted within 6 months prior to registration certificate expiration date Quality System Documentation 3 years of validity Re-registration must be submitted at least 6 months prior to the registration certificate expiration date

30 Product Variations

31 Type of variation applications Technical Variation Change of intended purpose Change of indication for use Administrative Variation Change of product name Change of manufacturer/sponsor information Change of IFU Add or remove model number and specification

32 What has changed & What s NEXT?

33 What has changed Mandatory STED format for all Class III registrations Specific Labelling formats TFDA now only accepts 11 Notified Bodies for purpose of QSD abridged pathway is yours one of the favoured 11? What s NEXT? New Medical Device Act (unpublished draft)

34 Sydney Thank you for joining us This webinar has been recorded and will be distributed along with a copy of the slides and Q&A s. Contact Us Wellington Suite 5, Level 8, 1 Chandos Street St Leonards NSW 2065 Australia Beijing Sydney: Beijing: Wellington: help@brandwoodbiomedical.com Point Howard, Lower Hutt 5013 New Zealand Unit , JGMW DRC, 1 Xiushui Beijie, Chaoyang District, Beijing PR China

35 Clinical Evidence Report Worldwide, regulators are strengthening clinical evidence standards, with requirements to document clinical literature, post-market data and predicate device comparisons. Ask us about our expertise and track record in CERs for Europe, China and Australia help@brandwoodbiomedical.com

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