changes to international regulatory requirements gail christie december 2, 2009

Changes to International Regulatory Requirements

Gail ChristieDecember 2, 2009

Covidien | December 3, 2009 | Confidential2 |

Agenda

Brazil

Mexico

Canada

India

China

Japan

European Union

Saudi Arabia

Turkey


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


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


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


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


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


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


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


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


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


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/


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 yearhttp://eng.sfda.gov.cn/eng/


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


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


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


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


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


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


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


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


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


The views expressed are those of the author. They do not necessarily reflect the position of Covidien.


Supplemental Information:Global Glossary


Global GlossaryBrazil

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


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.


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


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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