Transcript Slide 1

Changes to International
Regulatory Requirements
Gail Christie
December 2, 2009
Agenda
Brazil
Mexico
Canada
India
China
Japan
European Union
Saudi Arabia
Turkey
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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
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Rule RDC 25 – issued and signed into regulation May 22, 2009
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GMP certificate due with all registrations post March 2010
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Applies to all Class III, IV, specific Class II devices, and in-vitro
diagnostics
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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
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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
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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
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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
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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
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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
Canada’s 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
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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
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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
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India (cont)
•
•
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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/
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China
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•
•
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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/
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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
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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
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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
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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
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European Union
Medical 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
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European Union
Medical 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
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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
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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 importer’s contact information
•TITUBB (Turkish National Drug and Medical Data Base)
– EAN 13 required on label
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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
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The views expressed are those of the author. They
do not necessarily reflect the position of Covidien.
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Supplemental Information:
Global Glossary
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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 – China’s 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 – People’s Republic
of China – The formal legal name of the country of China.
SFDA – State Food and Drug Administration – Chinese government agency
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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 l’Industrie des Dispositifs de Soins Médicaux, Association of Medical Disposables and
Therapies
CEPP – Commission d’Évaluation 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.
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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
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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
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