Changes to International Regulatory Requirements

1
Changes to International Regulatory Requirements

• Gail Christie
• December 2, 2009

2
Agenda

• Brazil
• Mexico
• Canada
• India
• China
• Japan
• European Union
• Saudi Arabia
• Turkey

3
Brazil

• ANVISA (National Health Surveillance Agency)
• Regulates medical device by Law No. 6360, Decree
  74.094/97. Brazil is included in Mercosur
  Harmonization Group (Argentina, Paraguay,
  Uruguay)
• 6 24 months review time
• Rule RDC 25 issued and signed into regulation
  May 22, 2009
• GMP certificate due with all registrations post
  March 2010
• Applies to all Class III, IV, specific Class II
  devices, and in-vitro diagnostics

4
Brazil (cont)

• ANVISA will require inspection and a GMP
  Certificate for each manufacturing plant
  importing devices into Brazil.
• Certificates will be valid for two (2) years,
  audits will occur every two (2) years
• Yearly renewal certification fee of approximately
  US 18,500.00 plus audit expense, when applicable
• Open GMP certificate issue,
• Legal Manufacture
• Manufacturing Site
• Both

5
Brazil (cont)

• According to industry working groups, ANVISA
  recently stated that they may accept a Notified
  Body audit and evidence of a ANVISA audit request
  due to capacity.
• Currently, the auditing task force consists of
  Brazil state agencies and reviewer regulatory
  specialists. Industry is concerned that the task
  force will result in an increase in product
  review times.
• ANVISA committed to answering industry concerns
  regarding RDC 25 by 12/2009.
• RDC 25 audit does not negate the requirement for
  an IEC audit
• http//anvisa.gov.br/eng/index.htm

6
Mexico

• COFEPRIS (Comision Federal para a Proteccion
  contra Riesgos Sanitarios), a div of Mexican
  Ministry of Health Department (Established 2001)
• General Health Law
• Issued Regulation of Health Supplies
• Grants COFEPRIS power to act independent of the
  Ministry of Health
• Acts as the implementing regulation
• Based on a three (3) Class system
• Classification guidance document issued

7
Mexico (cont)

• New amendment to the regulation posted January 2,
  2008
• All current registrations older than 5 years to
  be renewed by February 24, 2010
• 5 year expiration date
• COFEPRIS backlog
• New amendment posted June 19, 2009 to amend
  approval times
• National Development Plan 2007 2012
• Class 1, no response from COFEPRIS within 30
  days, approved
• Class 2, no response from COFEPRIS within 30
  days, rejected
• Class 3, no response from COFEPRIS within 60
  days, rejected
• Labeling standard change (NOM-137-SSA1-2008)
  effective February 2009
• Third party manufacture information must be on
  the label
• http//portal.salud.gob.mx/index_eng.html

8
Mexico (cont)

• Recent update from Advamed (11/30/09)
• Commissioner Toscano publically recognized that
  getting the medical devices into the Renewal
  Process was a mistake
• and that the Law would have to be reformed
  again..
• ..but he is not pushing back on the 24 of
  February 2010 requirement.
• http//portal.salud.gob.mx/index_eng.html

9
Canada

• Implementation of the Summary Technical Document
  (STED) - Medical Devices Bureau will update the
  existing guidance document.
• Increased use of outside scientific expertise to
  reduce current backlog and speed up review times
  for applications.
• Increased emphasis on the use and recognition of
  standards in pre-market reviews.
• E-review Capability plan to establish an
  electronic review environment to provide support
  to the electronic submission and increase
  efficiency of the review for device applications.
• Cost Recovery - Current fees are out-of-date
  based on Health Canadas costs of doing business.
  Updated fees could be in place in 2010/2011.
• http//www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php
  

10
India

• Government assigned Central Drugs Standard
  Control Organization (CDSCO) and Department of
  Science and Technology (DST) to develop medical
  device regulations
• Government plans to amend current Drug
  regulations, rather than create a separate law
  for the device regulation
• Recent information indicates that the CDSCO
  branch will be responsible for medical device
  dossier review
• M-III Final draft amendment submitted for public
  review on Feb 23, 2009
• Two (2) year implementation time frame after
  approval

11
India (cont)

• Government created the Expert Committee at the
  Drugs Controller General of India (DCGI) to
  review and comment on the M(III) draft
• Participants, not inclusive list
• Confederation of Indian Industries (CII)
• Federation of Indian Chamber of Commerce and
  Industry (FICCI)
• Association of Indian Medical Device Industry
  (AIMED)
• Indian Council of Medical Research (ICMR)
• Bureau of Indian Standards
• Medical Fraternity

12
India (cont)

• Expert Committee Responsibilities
• Define modalities of Notified Bodies
• List Class C D devices
• Define the required changes to the Drug rules
• Develop a plan for Medical Device Regulations Act
  (MDRA) incorporation into M(III)
• Create guideline for 2 year implementation
• GHTF alignment
• Device class regulated by listing
• Current situation at Drugs Controller Government
  (India) DCG(I)
• Chaotic
• Misplaced dossiers
• Registrations expiring
• No response from regulators due to conflicting
  responsibilities
• http//cdsco.nic.in/

13
China

• State Council Order 276 and SFDA Order 16, draft
  updates to regulation
• AdvaMed and Joint Commission on Commerce and
  Trade (JCCT) met with SFDA on Sept 10, 2009
• Highlights from meeting
• China agreed to adopt GS1 standard for UDI.
• Appeared to consider accepting the GHTF
  registrations, rather than country of origin
  registrations. To be determined in the next
  draft.
• Manufacturing site inspections by China officials
  in the future
• Delegation was not successful in gaining
  agreement to limit China clinical study
  requirements
• Next draft to be submitted to industry before end
  of year
• http//eng.sfda.gov.cn/eng/

14
China (cont)

• US Department of Commerce released a news update
  on October 29, 2009 describing further agreements
• China agreed,
• product recalls will not be duplicative and will
  be managed by one government organization
• to adopt a risk based approach to clinical study
  requirements
• to accept a prior approval document issued by a
  foreign country regardless of the country of
  origin
• to consider an exemption of requiring samples to
  be tested in Chinese test labs prior to approval
  if manufacturer meets international standards and
  provides sound scientific evidence
• to strive to implement regulations in line with
  GHTF guidelines

15
China (cont)

• Notification on Matters Concerning Registration
  of Drugs and Medical Device Combination Products,
  SFDA Issued November 16, 2009
• Drug and medical device combination products in
  which the drug plays the leading role shall apply
  for drug registration drug and medical device
  combination products in which medical device
  plays the leading role shall apply for medical
  device registration.
• Article six states that combination products not
  approved in the country of export and/or products
  whose drug has not been approved in the country
  of legal manufacture will not be accepted.  
• Not compatible with recent discussions regarding
  country of origin
• Overlooks the situation in which a drug may only
  be used in combination with a medical device and
  would not have a separate drug approval

16
Japan

• PMDA (Pharmaceuticals and Medical Device Agency)
• MHLW (Ministry of Health, Labor, and Welfare)
• Action Program Established April 2009 to monitor
  reform
• Update from Action Program Working Groups
• Partial change definition in line with FDA 510(k)
  process
• Stability Test Data
• MHLW issued a guidance document on accelerated
  aged data
• Clinical Data notification issued 2008
• Clinical evaluation guidance drafted
• PMDA is likely to issue a guidance document on
  this subject sometime next year
• Submission bundling subgroup review
• orthopedics pacemakers dialyzers oxygenators
  and medical equipment/machinery under
  consideration

17
Japan (cont)

• Future
• 3 track submission system by 2011
• Yearly 3rd party reviewer to summarize action
  plan progress against goals
• Increase to 104 reviewers by 2013, decrease
  review times to
• 12 months for new device application
• 7 months for improved device application
• http//www/pmda.go.jp/english/index/html

18
European UnionMedical Device Directive 93/42/EE
Amendment 2007/47/EC

• Amendment to 93/42/EC and AIMDD 90/385/EEC
  (Active Implantable)
• Published Oct 11, 2007
• European Commission issued an interpretative
  document June 9, 2009
• ENTR/F3/PBE/D(2009)119003
• March 21, 2010 enforcement, not inclusive
• Definition of central circulatory system has been
  expanded for Class III
• Includes the vessels aortic arch and descending
  aorta to the aortic bifurcation.
• Record retention lifetime of the product, not
  less than five years. Implantable devices at
  least 15 years after the last product has been
  manufactured

19
European UnionMedical Device Directive 93/42/EE
Amendment 2007/47/EC(cont)

• March 21, 2010 enforcement, not inclusive (cont)
• Clinical Evaluations required for all devices,
  regardless of classification
• Clarification on single use
• Phthalates labelling for all products
• Product for use on children or pregnant women
  require justification in the Technical File and
  Instructions for Use
• Stand alone software as an active medical device
• Outsourced design and manufacturing must be more
  closely monitored
• Instructions for Use must be revision controlled
• Definitions of continuous use expanded

20
European Union (cont)

• Medical Device Directive Recast
• On hold, projected to resume 2010
• Machinery Directive 2006/42/EC applicable to
  Medical Device as of December 29, 2009
• Where a medical device is also a machinery, it
  shall meet the essential health and safety
  requirements of the Machinery Directive to the
  extent to which they are more specific than the
  essential requirements of the MDD

21
Turkey

• Country of Origin Discrimination at Customs due
  to 2009/16 regulation
• Effective January 1, 2009, one day after
  publication
• If country of Origin is not an EU state, 3 day to
  3 week hold delay
• DOC, EC certificate, Application, Turkish IFU
  required at Customs
• Physical product checks, when requested
• Missed tender deadlines
• Turkish Labeling Requirements
• Checked at customs, hospitals and reimbursement
  authorities
• All words must be translated to Turkish,
  including symbol statements
• Introducing a product to market starts at
  customs, therefore label must be applied prior to
  customs entry
• Additional label required for importers contact
  information
• TITUBB (Turkish National Drug and Medical Data
  Base)
• EAN 13 required on label

22
Saudi Arabia

• Saudi Food and Drug Authority (SFDA)
• Posted Regulations and Implementing Rules
• Medical Device Interim Regulations Decree
  1-8-1429, December 27, 2008 (published April 17,
  2009)
• Implementing Rules for
• Establishing Licensing
• Establishment Registration
• Medical Device Listing
• Designation and Oversight of Conformity
  Assessment Bodies
• CAB shall not be the manufacturer's assigned
  Notified Body or authorized representative
• GHTF alignment
• http//www.sfda.gov.sa

23
The views expressed are those of the author. They
do not necessarily reflect the position of
Covidien.
24
Supplemental InformationGlobal Glossary
25
Global Glossary

• Brazil
• ABIMO Domestic Medical Device Association
• ANVISA National Health Surveillance Agency. GOB
  - Government of Brazil
• Mexico
• AMID Association for Medical Industries for
  Innovative Medical Devices
• China
• AmCham The American Chamber of Commerce in
  China Industry association
• AQSIQ General Administration of Quality
  Supervision, Inspection and Quarantine One of
  the two main Chinese government agencies that
  tests medical devices prior to regulatory
  approval and conducts audits of manufacturing
  facilities.
• CAMDI China Association for Medical Device
  Industry Chinas largest domestic medical
  device industry association, which has a formal
  relationship with several government agencies,
  including SFDA and the NDRC.
• JCCT - Joint Commission on Commerce and Trade
• MHRSS - MHRSS  Ministry of Human Resources and
  Social Security
• MOFCOM Ministry of Commerce Chinese
  government ministry..
• MOH Ministry of Health Chinese government
  ministry.
• NDRC National Development and Reform Commission
  Chinese government agency PRC Peoples
  Republic of China The formal legal name of the
  country of China.
• SFDA State Food and Drug Administration
  Chinese government agency

26
Global Glossary

• Europe Union
• COCIR Association of the European Radiological,
  Electro medical and Healthcare IT Industry. 
• EDMA European Diagnostic Manufacturers
  Association
• EUCOMED European medical device association
• MDD Medical Device Directive (93/42/EEC)
• France
• APIDIM  Association of US-Based device
  manufacturers in France.
• APPAMED Syndicat de lIndustrie des
  Dispositifs de Soins Médicaux, Association of
  Medical Disposables and Therapies
• CEPP Commission dÉvaluation des Produits et
  Prestations Committee for Assessment of Devices
  and Health Technologies, within the HAS.
• CEPS -- Comité Économique des Produits de Santé,
  Economic Committee for Health Products, within
  the French Ministry of Health.
• GHS Groupes Homegenes de Sejour, French
  DRG-style system of payment groups, under the
  T2A  payment system.

27
Global Glossary

• France (cont)
• HAS French High Authority on Health,
  responsible for health technology assessment.
• SNITEM  Syndicat National de l'Industrie des
  Technologies Médicales, French Medical Devices
  and Equipment Association
• DRG - Diagnosis Related Groups
• Germany
• Aktion Meditech joint public relations campaign
  by BVMed, AdvaMed and interested member companies
• BVMed German medical technology association
• GOG Government of Germany
• IQWiG - Institute for Quality and Efficiency in
  Healthcare (IQWiG)
• JFC - Joint Federal Committee (Bundesausschuss
  Krankenhaus also called G-BA) - The G-BA performs
  the political and economical appraisals.
• SHI Statutory Health Insurance
• India
• DCG(I) Drug Controller Government (India)
  regulatory agency
• GOI- Government of India

28
Global Glossary

• Italy
• Assobiomedica Italian association for medical
  devices
• CUD technical body of the MOH with the function
  to analyze the minimum and maximum unit prices
  for medical devices.
• DEHP Bis (2-Ethylhexyl) Phthalate
• GOI Government of Italy
• MOEF Ministry of Economy and Finance
• MOH Ministry of Health
• NHS National Health System
• REACH - is a new European Community Regulation
  on chemicals and their safe use (EC 1907/2006).
  It deals with the Registration, Evaluation,
  Authorisation and Restriction of Chemical
  substances.
• SVHC Substance of Very High Concern