REGULATORYAPPROVAL ae sigel MEDICALDEVICES eTASPECTS Ce * Medical Devices — What are they? + European Union —An Overview * EU Directives that impact Medical Devices * Medical Devices.as defined by EU * Classification of Medical Devices as per EU * The CE Certification * The Registration Process for MD * The Process Timeline for RegistrationMEDICAL DEVICES ed * A medical device is an instrument, apparatus, implant, in vitra reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions It does not achieve its purposes through chemical action within or on the body. Medical devices vary greatly in complexity and application. The design of medical devices constitutes a major segment of the field of biomedical engineering. Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing, implants, and prostheses. The global medical device market reached roughly $209 billion in 2006. ‘etc Slhand[2 a > (2 ee03EU DIRECTIVES THAT IMPACT bd MEDICAL DEVICES * Medical Devices (MDD) 93/42/EEC * Covers the bulk of medical devices marketed in the EU + Examples: orthopaedic implants, heart valves, medical software + Active Implantable Medical Devices (AIMDD) 90/385/EEC * Covers devices that require external power sources in order to function properly + Examples: pacemakers, implantable defibrillators * InVitro Diagnostics (IVDD) 98/79/EC * Covers devices used for the examination of specimens taken from the human body + Examples: pregnancy self-testing strips, blood glucose self-testing strips ‘etchedOTHER EU DIRECTIVES THAT MAY APPLY TO MIEDICAL DEVICES Personal Protective Equipment 89/686/EEC Low Voltage 2006/95/EC Electromagnetic Compatibility 2004/108/EC Blood Product Directive 2002/98/EC Animal Tissue Use in Medical Devices 2003/32/EC Human Tissue Products Directives 2004 & 2005 Breast Implants Reclassification Directive 2003/12/EC Hip, Knee, Shoulder Joint Replacement Reclassification Directive 2005/50/ECMEDICAL DEVICES AS DEFINED BYEUROPEAN UNION Medical Devices: Guidance Document MEDDEV 2.1/1 APRIL 1994 This guidance document under Directive 93/42/EEC on Medical Devices provides definition of Medical Devices to include the following: a. Devices—Accessory b. Medical Purpose ¢. Customizing d. Medical —Toiletry Purpose e, Aids for Handicapped Persons f. Software g. Multipurpose ProductsCLASSIFICATION oF mepicat Devices AS PEREUROPEAN UNION Medical Devices: Guidance Document MEDDEV 2.4/4 Rev.8 JULY 2004 MEDDEV 2.4/1 Rev.9 JUNE 2010 * The classification of medical devices is a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices. + This approach allows the use of a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness and local vs. systemic effect. These criteria can then be applied to a vast range of different medical devices and technologies. » These are referred to as the ‘classification rules’ and are set out in Annex IX of Directive 93/42/EEC ‘kot ilhendTHEC € CERTIFICATION eS * The CE mark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985, * The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. * This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. * It is in that sense similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States. It consists of the CE logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure, The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives. ‘kot ilhendet EcerniricarionKEY PLAYERS in tHe CE MARKING PROCESS (REGULATORY APPROVAL PROCESS FOR MEDICAL DEVICES) + Manufacturers and Subcontractors * Competent Authorities * Notified Bodies * Authorized Representatives * DistributorsOMX GTHORITIES * Competent Authorities are entities enforcing Medical Device Directives at the national level in each EU member state. * Member states and their Competent Authorities each have their own interpretations of how Directives should be carried out. * Manufacturers seeking to sell in more than one EU member state should take this into account.bd NOTIFIED BODIES * Notified Bodies are authorized to audit manufacturers’ quality systems and test/review devices for compliance with applicable EU Directives and standards. * Their responsibilities include: + Advising on device classification and Conformity Assessment routes * Pre-assessment of devices + Product and quality system evaluation * Concluding and evaluating manufacturers’ Corrective Actions + Issuance of certifications Maintaining programmed surveillance of devices in the EU* Required for any firm without a location in the EU. * Their responsibilities include: * Liaising between manufacturers and Competent Authorities * Listing their names on clients’ device labels and packaging Notifying Competent Authorities of manufacturers’ and devices’ names + Keeping Technical Files/Design Dossiers available for review by Competent * Authorities Participating in vigilance/post-market surveillance proceduresBASIC STEPS TO EU COMPLIANCE Identify Directives and Regulations appropriate for your device = s Classify your device according to MDD Annex IX + Implement Quality System in compliance with ISO 13485. + Prepare Technical File or Design Dossier demonstrating compliance with MDD 93/42/EEC. Ta. Ii | Appoint your Authorized Representative. = s Have Notified Body audit your Quality System and Technical File or Design Dossier. + Register your device with Competent Authorities if necessary. s Prepare Declaration of Conformity and affix CE Marking to your device.LASSIFICATION == * First, determine which Medical Device Directive (MDD, AIMDD or |VDD) applies to your device. + Then determine device classification using Annex IX of MDD 93/42/EEC.oe sTEP|) CLASSIFICATION ma CONTINUED Class lla a Medium-risk, short-term invasive devices such as ( tracheal tubes and lancets X Class IIb “ Higher-risk, often longer-term surgically invasive, - | sometimes implantable devices including intra-ocular = lenses and surgical lasers ae Highest-risk devices, including all active { tf p implantable devices such as replacement heart valves and vascular stentsstep) CLASSIFICATION CONSIDERATIONS * MDD 93/42/EEC Annex |X contains 18 rules for medical device classification based on factors including the following: * Device’s intended use * Active versus non-active functionality * Device's duration of contact with patient * Degree of invasiveness + Part of body contacted by device * Special situationsal step) CLASSIFICATION DETERMINATION * Duration of Contact Criteria * Less than 60 minutes = Transient * Less than 30 days = Short-term * More than 30 days = Long-term * Degree of Invasiveness Criteria * Application to body surface versus an orifice * Surgically invasive or non-invasive * Implantable Determining your device's duration of contact and degree of invasiveness will help determine how to classify the device. ‘tolledLASSIFICATION DETERMINATION Class Ila Class Iboe ca ster 2 QUALITY system [ie ; Manufacturers of Class | 13485 sterile/measuring, lla, IIb and Ill devices He] must implement quality management systems (QMS) (in compliance with Annex Il or V of the MDD). Most manufacturers meet this requirement using ISO 13485.13485 Phase I: Quality system preparation and development * Management buy-in * Assign resources and staff * Conduct gap analysis * Develop quality manual and documentation controls Phase Il: Implementation * Employee training + Internal auditing * Corrective and preventative actions Phase Ill: Registration * Registration audit performed by Notified Body * Final 1SO 13485 certificationECHNICAL FILE bd DESIGN DOSSIER PREPARATION * All Class |, lla and IIb device manufacturers must prepare Technical Files containing data to demonstrate MDD 93/42/EEC compliance. Class Ill device manufacturers must prepare Design Dossiers to demonstrate compliance to MDD. All manufacturers must have clinical data to demonstrate compliance to MDD.STEP. TECHNICAL FILE COMPONENTS. | feysexag ACR A cere eran Nac ANH OAANi(ec1¢ (Vancom vTap ae (eLeLael ware} lemokree ni erate cae tenet Description of device components, specifications, packaging and eis Priel ie taal ile facet ) Metre ate TS 1 2 F ey 5 A 7 Location of design responsibility and manufacturing facilities Classification along with rationale for classificationTECHNICAL FILE COMPONENTS. Chosen compliance route according to applicable Directive(s), Declaration of Conformity stating manufacturer's compliance with:applicable Directive(s) Shelf life and énviréamental limitations of device een of quality assurance, Competent Authority and Notified Body records Vigilance reporting and Medical Device Reporting procedures How and when to.contact Competent Authorities Name of and'contract with your Authorized Representativestep =,TECHNICAL FILE Eee sae merece ce ena yale st Essential Requirements Design input specifications Application and references to Standards and Guidelines Testing results and-clinical evaluations. ace Es ie iegU aero acel Ota. 1aYell E-le\- are}TECHNICAL FILE ca CLINICAL DATA REQUIREMENTS * EUregulators have increased their requirements for clinical data even for Class | medical devices in recent years. In many cases, manufacturers must submit Clinical Evaluation Summary Reports that verify the safety and performance of their products along with Technical Files or Design Dossiers.AUTHORIZED bE REPRESENTATION Manufacturers with no offices in the EU must appoint Authorized Representatives (EC REPs) to interact with regulators on their behalf.Ed sre FE EE ieimes Registering your device with Competent Authorities before commercialization * Serving as primary point of contact with all EU Competent Authorities * Keeping acurrent copy of your Technical File/Design Dossier available for inspections by Competent Authorities * Authorizing you to place EC REP name and address on your device labels, packaging and instructions for use * Handling Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities * Representing you before the European Commission in the event that your product is withdrawn in a member state * Protecting the confidentiality of your product information * Maintaining reports on clinical evaluation data for review by Competent Authorities Communicating with Competent Authorities on serious device incidents or FSCAS ‘klarNOTIFIED BODY ba AUDIT Following _*. a 2» your quality system and Technical File/Design Dossier must be audited by a Notified Body. Upon Successful completion of your audit, the Notified Body will Manufacturers of Class | Non-sterile/Non-measuring devices self-declare MDD conformity and do not require CE Marking certificates.REGISTRATION bd WITH COMPETENT AUTHORITIES Class | device manufacturers must register with the Competent Authority of the country where their EC REPs are based. Class Ila Class IIb = Some EU member states do not require registration of Class lla, IIb or Ill devices with Competent Authorities. Other countries do not require registration of devices.+ Inorder to complete the CE Marking process, all prepare a Declaration of tet in compliance - ee Declaration of Conformity, you may affix CE Marking to your product.a DECLARATION OF CONFORMITY STEP E PARTS Product Identification i. Etat cm ulti 1a fem oleh) ed ¢ Applicable DirectivesLABELING AND LANGUAGE bd RQUIREMENTS + EU member states MAY require labeling information be made available in their local languages or another European Community language to patients and users in accordance with Annex |, point 13 of the MDD. * Alllanguages subject to subsidiarity All EU member states require device labeling in their official languages Label information in your Technical File should only appear in ONE language ‘etchedPaes Pee alm CeCe ESIC Breen ten old ee be eee ed eg en at Puc eee uC Overall Cost of Pours Ua a PC od Registration ee Class | NS/NM <4 Month No Expiry ApplicablePOST-MARKET SURVEILLANCE (PMS) AND VIGILANCE PMS required for all medical devices sold in the EU Manufacturers are required to develop proactive plans for PMS PMS plans should include reviews of market and field data, complaints and corrective actions Systematic records of PMS findings must be kept * Purpose of Vigilance Requirements: * Protecting public health and safety + Evaluating incidents to prevent recurrence * Determining effectiveness of corrective actions taken * Monitoring and learning from experience + Vigilance Requirements for Manufacturers: Establish and maintain systematic procedures to review experience gained from devices in the post-production phase Implement appropriate means to apply any necessary corrective actions ‘etc lhandREFERENCES bd IN THE ORDER OF APPEARANCE : f Witches Hea Bie Mir Mgavrops elk ewisara urs PDE a a production slentfir (M1), a canditional, varuhle orien sf’ IDI ttt Wentiies one fore afte bekvwing when Mekiled on the bbe! oa deve the eto aie mariser ena Wich wise Us musta te soinl martes of a specie dove the expiemton ate of wpecee device: the date specie downs as manabictar: the ditinet Memibieation code requred by $1271.2004e) fe human sel sue, OF cot and tssue based prnluct HICTI®) regu asa device FOUK STEPS TOA SOCCESSHUL, UDEMMOGRAM: 1. Develop a standardized sytem 1 create the LDL 2 Mice UDI on bbe or sometemes dove 4. Create aia rantaen Ciba UDI aveatone 4 Adopoom and erpieniciaatian by al stakebnitios ‘Obgetives of the Unique Device Meaifeation Peoria4 lp ne ace tual MEDIGAN By a .« uy Presented by: ~ Mr.SURAJ P,FACILITATED BY: DrM.P. VENKATESH Assistant Professor Dept. of Pharmaceutics Regulatory Affairs Group JSSCP MYSURU Vinod Rak L.M.Pharm Regulatory Affairs group ISSCP MYSURUREGULATORY REQUIRNMENTS AND APPROVAL PROCEDURE OF DRUGS IN JAPAN githin PRESENTED BY?SANDEEP BANSAL CLASS *M-PHARMACY 1* year (DRA) ROLL NO, 180000802004®@oins Overview and Update of Chinese Medical Device Regulation CIRS Group | Medical Device BU Yolanda [email protected] 2019.12.05 AUGMHE (ORS) CAR BAAR weracirs-group.comfmndCatlins INVESTIGATIONS oo od o