TRANSITION PLAN FOR THE IMPLEMENTATION OF MEDICAL DEVICE ACT 2012 (ACT 737) Seminar on MEDICAL DEVICE ACT 2012 (ACT 737) PICC, Putrajaya 28 June 2012 MEDICAL DEVICE CONTROL DIVISION, Ministry of Health Malaysia ● Level 5, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya● www.mdb.gov.my ● [email protected] ● Tel: 603-88850600 ● Fax: 603-88850759 OVERVIEW OF THE REGULATORY FRAMEWORK PRE-MARKET PLACEMENT ONMARKET POST-MARKET SURVEILLANCE & VIGILANCE Establishments shall • monitor safety & performance of products • carry out post-market obligations, eg complaint handling, FSCA, recall PRE-MARKET ASSESSMENT Manufacturers of medical devices shall • ensure their products conform to EPSP • establish appropriate quality system for manufacturing their products • collect evidence of conformity MEDICAL DEVICE REGISTRATION • Manufacturers (or LARs) apply to register medical devices & establishment license CAB verifies evidence of conformity ESTABLISHMENT LICENSING Importers/distributors shall • ensure compliance to GDP & advertising requirements • apply for establishment license to import/distribute medical devices USAGE & MAINTENANCE • Users shall use, maintain & dispose off medical devices appropriately • Users shall apply for permit to use/operate designated medical devices MDA monitors compliance to requirements & takes appropriate actions in accordance with the provisions of the law Medical Device Control Division MINISTRY OF HEALTH MALAYSIA central circulatory system. hearing aids. tongue depressor. aspirator. stethoscopes. anesthetic breathing circuits.RISK-BASED CLASSIFICATION & REGULATORY CONTROL • A classification of medical devices based on risk associated with the vulnerability of the human body. deep wound dressing. inter-uterine contraceptive devices. central nervous system) Class A Risk Level Low B LowModerate Regulatory control C D HighModerate D High R I S K Device examples Simple surgical instruments. walking aids Hypodermic needles. neurological catheters. oxygen mask. surgically invasive interventions. suction equipment. blood oxygenator. contact lens disinfecting/cleaning products. x-ray films Lung ventilator. liquid-in-glass thermometer. simple wound dressing. ventilator Pacemakers and their leads. heart valves. implantable infusion pumps. baby incubator. the technical design and the manufacture of the medical device It uses a set of classification rules based on: intended use duration of use (transient. implantable defibrillators. orthopedic implants. examination light. short-term and long-term) part of human body (non-invasive or invasive with respect to body orifices. radiological therapy equipment. vascular prostheses. defibrillator. external bone growth simulators. patient controlled pain relief. stents C B A Device risk/class Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . phototherapy unit. hydrogel dressings. blood bag. CONFORMITY ASSESSMENT Conformity assessment (CA): Systematic examination of evidence generated and procedures undertaken by the manufacturer under the requirements established by the Regulatory Authority to determine that a medical device is safe and performs as intended by the manufacturer and. conforms to the Essential Principles of Safety and Performance for Medical Devices Medical Device Control Division MINISTRY OF HEALTH MALAYSIA What To Look For In CA? Objective evidence for conformance to Essential Principles of Safety & Performance of Medical Device – 6 general principles 11 design and manufacturing principles . therefore. physical and biological properties Infection and microbial contamination Manufacturing and environmental properties Devices with a diagnostic or measuring function Protection against radiation Requirements for medical devices connected to or equipped with an energy source Protection against mechanical risks Protection against the risks posed to the patient by supplied energy or substances Protection against the risks posed to the patient for devices for self-testing or self administration Information supplied by manufacturer Performance evaluation including where appropriate. clinical evaluation .CONFORMITY ASSESSMENT Essential Principles of Safety & Performance of Medical Device General Principles Medical device should be designed & manufactured in such a way that: no compromise to clinical condition or safety of patients. or safety and health of users or other persons control the risk so that residual risk is brought down to an acceptable level suitable for one or more of the functions within the scope of the definition of a medical device characteristics and performances should not be adversely affected to such a degree that they compromise the health or safety of patient or user and other persons during the lifetime of the device characteristics and performances during their intended use will not be adversely affected under transport and storage conditions benefits must be determined to outweigh any undesirable side effects Medical Device Control Division MINISTRY OF HEALTH MALAYSIA Design and Manufacturing Principles Chemical. Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices) • FSCA reporting (GHTF recommendations . importer. inspection & testing –For Class C. ISO 13845 or equivalent –Class A & B products. full QMS • PMS system • Technical evaluation of sterilization process (if any) • For LAR. can exclude design control. process control.Essential Principles of Safety & Performance of Medical Devices) • Acceptable standards or equivalence will be widely used (GHTF recommendations Role of Standards in the Assessment of Medical Devices) • CAB determines the adequacy of the documented evidence to support attestation of conformity Quality Mgmt System (QMS) • For manufacturer. distributor: GDPMD Post-Market Surveillance System (PMS) • Distribution records • Complaint records • Adverse incident reporting (GHTF Medical Device Control Division MINISTRY OF HEALTH MALAYSIA recommendations .Medical Devices Post Market Surveillance: Content of Field Safety Notices) .CONFORMITY ASSESSMENT Elements of CA QMS (ISO 13485 or equivalent. full QMS –For Class D. GDPMD) Post-market surveillance system (GHTF recommendations) Summary technical documentation (ASEAN CSDT) Declaration of conformity (DoC) (GHTF recommendations) Registration of medical device & licensing of establishment Declaration of Conformity (DoC) • A DoC is a declaration made by the manufacturer of a device that the device is in conformity with the regulatory requirements • DoC declares that the manufacturer guarantees that each piece of the device sold is in conformity with the regulatory requirements Summary Technical Documentation • Format – ASEAN CSDT • Compliance to EPSP (GHTF recommendations . if necessary. withdraw authorization . However.CONFORMITY ASSESSMENT CA PROCESS & PARTIES INVOLVED Conformity assessment is primarily the responsibility of the medical device manufacturer. it is done in the context of the established regulatory requirements and both the process and conclusions are subject to further review by the Regulatory Authority Medical Device Control Division MINISTRY OF HEALTH MALAYSIA Manufacturer conducts CA on. (i) QMS & PMS (ii) Product safety & performance (summary tech doc & DoC CAB reviews evidence of conformity Authority reviews & registers product & licenses establishment What is a CAB? A body authorized by the Authority to perform specified CA activities to determine whether the relevant requirements in technical regulations or standards are fulfilled CAB is independent of the organization that provides the product and is not a user of the product (3rd party) Authority will monitor the performance of the CAB and. Class A may be audited for special cases. make available upon request. audit may be required to investigate specific safety or regulatory concerns C A – Self declare B D – Product design & manufacturing control R I Tech doc CSDT S DoC K Registration & licensing Prepare. maintain full QMS make available for audit PMS system Establish & maintain adverse event reporting procedure for audit. Class A(S) Class A(M) Class B Class C Class D QMS Est & maintain – can excl design & dev control. For Class B.CONFORMITY ASSESSMENT Level of CA The level of CA is proportional to the risk associated with the device Class Class A. For Class B may be reviewed for conformity to EPSP Prepare & submit for review Prepare. make available for audit Establish. For Class A. sign & submit for review Perform according to requirements Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . database & resource center Forms Criteria Procedures Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . ie the Acts Subsidiary legislations & guidance documents Medical Device Authority & organization Registration & licensing system – – – – – Internal processes & procedures Register.WHAT DO WE NEED TO IMPLEMENT THE REGULATORY SYSTEM? • • • • Legal support. Application Form 2. If no.Clinical evidence Class C&D – Clinical Evaluation Evaluation Decision Yes Grouping: • Single • System • Kits • Group Yes r Pay fee B. Class B. D Conformity Assessment By CAB or MDA 1. attestation by manufacturer Division 4.Application Form 2. C. Certified QMS. D Class? A Class A Sterile MD -ISO 13485 (In-House) -ISO 13485 (Sterile Services) -Process Validation (Report) Class A Measuring Function MD -Process Validation (Report) Class A 1. DC from Product Owner/Manufacturer 3. C. 2.MEDICAL DEVICE REGISTRATION ROUTES Stop No Medical device? B. C if Required.CSDT 4. Declaration of conformity 3. Technical File ISO 13485 QMS Stop No No Qualified for abridged? OK? Yes Yes 1. Simplified CSDT MEDICAL DEVICE REGISTER Medical Device Control MINISTRY OF HEALTH MALAYSIA . but does not include a retailer Different type of establishment has different roles & responsibilities – different set of control Establishment must possess valid license to carry out activities related to medical devices in Malaysia Medical Device Control Division MINISTRY OF HEALTH MALAYSIA Foreign manufacturer Importer Authorized representative Local manufacturer Distributor Distributor Imported device Locally-made device Relationship between different establishments . importer or distributor of medical devices. authorized representative (for foreign manufacturer).LICENSING OF ESTABLISHMENTS Establishment means a person/organization who is either a manufacturer. LICENSING OF ESTABLISHMENTS Authorization: Appropriate authorization from the respective establishment is required as a pre-requisite for the issuance of license Authorized rep must be authorized by foreign manufacturer Importer must be authorized by authorized rep to import devices on its behalf Distributor must be authorized by manufacturer/ authorized rep to distribute devices on its behalf An entity may apply for license for different types of establishment Medical Device Control Division MINISTRY OF HEALTH MALAYSIA Manufacturer as defined in Section 2 of MD Bill 2011: definition of “manufacturer” Authorized representative as defined in Section 2 of MD Bill 2011: definition of “manufacturer” • Authorized representative must be natural or legal person with business registration in Malaysia. Distributor: Any natural or legal person in the supply chain authorized by the manufacturer/authorized representative to further the availability of medical devices to the end-user. available in the Malaysian market . In some circumstances. more than one distributor may be involved in this process Importer: Any natural or legal person authorized by authorized representative. who first makes a medical device manufactured in other countries. • It must maintain linkage with its foreign manufacturer and should be able to obtain the support of its foreign manufacturer whenever required. – Distribution records – Complaint handling – Adverse incident reporting – Field safety corrective action • List of medical devices • ISO 13485 or equivalent Local manufacturer Authorized rep Importer Distributor • Good Distribution Practice for Medical Devices (GDPMD) Medical Device Control Division MINISTRY OF HEALTH MALAYSIA .LICENSING OF ESTABLISHMENTS Requirements • Establishment details • Appropriate authorization • Procedures for. GDPMD FOR AUTHORIZED REP. IMPORTER & DISTRIBUTOR Foreign manufacturer Local manufacturer Importer Local authorized representative Distributor Distributor Imported medical devices Importer Medical Device Control Division MINISTRY OF HEALTH MALAYSIA Locally-made medical devices Distributor . SAVINGS & TRANSITIONAL Section 80 of MD Act 2012 (Act 737): Savings and transition – All medical devices shall be registered within 24 months from the appointed date – All establishments shall be licensed within 12 months from the appointed date Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . CURRENT STATUS: THE ACT • MD Act 2012 (Act 737) & MD Authority 2012 (Act 738) – 3 Oct 2011: Passed by Lower House of Parliament – 7 Dec 2011: Passed by Upper House of Parliament – Already gazetted Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . to provide consultancy & advisory service and any other services in relation to medical device.Chief Executive of the MDA . consider and recommend reform to the medical device laws • To perform the following .to assist in the performance of the functions of the Authority Medical Device Control Division MINISTRY OF HEALTH MALAYSIA .CURRENT STATUS: ORGANIZATION • New statutory body setup: Medical Device Authority – early Q3 2012 • Human resource – already approved PSD MEDICAL DEVICE AUTHORITY (MDA) A body corporate with the following members .DG of Health as the Chairman . who have expertise and experience in medical device matters Functions of MDA • To implement.to regulate all matters . its industries and activities • To utilize property of the Authority in such manner as the Authority may think expedient • To impose fees or charges for services rendered Committees appointed by MDA .a representative of Min of Finance . enforce.not more than five persons appointed by the Minister.a representative of Min of Health . CURRENT STATUS: SUBSIDIARY LEGISLATIONS • MD (Pre-Market) Regulations – 1st phase: draft pre-market regulations is ready • Registration of MD – – – – – – – – Classification Grouping Conformity assessment procedure Application procedure for registration Renewal of registration Changes concerning registered MD Exemption Cancellation of registration • Registration CAB • Establishment license • Etc.. Medical Device Control Division MINISTRY OF HEALTH MALAYSIA • • • • • • Forms Fee structure Criteria Conditions Procedures Other details – To be submitted to AG’s Chamber: August 2012 . CURRENT STATUS: GUIDANCE DOCUMENTS Guidance Documents Awaiting publication Under development (i) Definition of Medical Device (ii) Risk Based Classification (iii) Essential Principles of Safety & Performance of Medical Device (iv) Common Submission Dossier Template (v) Good Distribution Practice for Medical Devices (vi) IVD Medical Device Classification System (vii) Essential Principles of Safety and Performance for IVD Medical Devices (viii) Conformity Assessment for IVD Medical Devices (ix) Common Submission Dossier Template for IVD Medical Device (i) Conformity assessment body (ii) Declaration of Conformity (iii) Guidelines for product registration (iv) Grouping of medical devices Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . • Otherwise. EU. CA is conducted to provide objective evidence of safety & performance a medical device Only registered medical devices can be placed into the market Establishments dealing with medical devices must comply with conditions and carry out their obligations Medical Device Control Division MINISTRY OF HEALTH MALAYSIA Who shall be responsible? – Licensed local manufacturers or authorized rep What would be required? – Submission of CSDT – Submission of DoC – Establishment. the medical device will be put in the Medical Device Register Abridged Assessment • Applicable for medical devices which have already approved by the relevant authority to be marketed in US. full assessment shall be done . maintenance and making available of QMS & PMS documents for audit Upon approval.REGISTRATION OF MEDICAL DEVICES Medical device regulatory system is based on safety & performance of medical devices throughout their life cycle Prior to registration of a medical device. Japan. Australia. Canada. CURRENT STATUS: MEDC@ST • New registration & licensing system ESTABLISHMENT LICENSING MEDICAL DEVICE REGISTRATION CAB REGISTRATION COMPETENCY REGISTRATION SERVICE PROVIDER REGISTRATION Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . MEDC@ST: ESTABLISHMENT LICENSING Authorized representative Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . MEDC@ST: MEDICAL DEVICE REGISTRATION Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . MEDC@ST: MEDICAL DEVICE REGISTRATION Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . NOW TO MANDATORY PHASE Passing of MD & MD Authority Bills Gazettement of MD & MD Authority Bills Announcement of appointed dates of implementation MD & MD Authority Acts Establishment of MD Authority Appointed date of implementation of MD Act Mandatory implementation MD Act 3-Oct-2011 30-Dec-2011 End Feb2 012 31-July-2012 31-Oct-2012 31-Oct-2014 Preparation & development of MD Act Preparation & development of computerized system Preparation & development of subsidiary legislations Appointment of members of MD Authority Appointment of Chief Executive of MD Authority Transition of MD Control Div to assist in the establishment of MD Authority Preparation & development of regulations. guidance documents & standards for the implementation of MD Act Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . NOW TO MANDATORY PHASE Licensing of Establishments Mandatory implementation of MD Act Appointed dates of implementation MD Act Establishment of MD Authority Phase 3: Imposition of other obligations Phase 2: Imposition of GDP for other establishments Phase 1: Imposition of ISO13485 for manufacturers Phase 5: Registration of IVD Registration of Products and CABs Phase 4: Registration of Class B &C Phase 3: Registration of Class D Phase 2: Registration of CAB Phase 1: Registration of Class A Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Gazettement of Bills Passing of Bills Q1 Q2 Q3 Q4 Q1 Q2 2011 2012 2013 2014 2015 Voluntary Medical Device Control Division MINISTRY OF HEALTH MALAYSIA Transition Mandatory . NOW TO MANDATORY PHASE CAB Registration System CAB registration system Implementation of CAB registration Development of CAB registration system CAB guidance document (GD) Finalization of GD Comments of GD from interested parties Development of GD June Medical Device Control Division MINISTRY OF HEALTH MALAYSIA July August September October . SUMMARY • Regulatory framework & legal support are in place • Current status: Work is progressing – putting the detailed pieces together • Moving forward – regulatory activities will be introduced in phases. timeline • Awareness & consultations Medical Device Control Division MINISTRY OF HEALTH MALAYSIA . Thank you for your attention Medical Device Control Division MINISTRY OF HEALTH MALAYSIA .….
Report "Transition Plan for Implementation of Medical Device Act 2012"