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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 mdb@mdb.gov.my Tel: 603-88850600 Fax: 603-88850759
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
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
intended use duration of use (transient, short-term and long-term) part of human body (non-invasive or invasive with respect to body orifices, surgically invasive interventions, central circulatory system, central nervous system)
Class A
LowModerate
Regulatory control
C D
HighModerate
High
Device examples Simple surgical instruments, tongue depressor, liquid-in-glass thermometer, examination light, simple wound dressing, oxygen mask, stethoscopes, walking aids Hypodermic needles, suction equipment, anesthetic breathing circuits, aspirator, external bone growth simulators, hearing aids, hydrogel dressings, patient controlled pain relief, phototherapy unit, x-ray films Lung ventilator, orthopedic implants, baby incubator, blood oxygenator, blood bag, contact lens disinfecting/cleaning products, deep wound dressing, defibrillator, radiological therapy equipment, ventilator Pacemakers and their leads, implantable defibrillators, implantable infusion pumps, heart valves, inter-uterine contraceptive devices, neurological catheters, vascular prostheses, stents
A
Device risk/class Medical Device Control Division MINISTRY OF HEALTH MALAYSIA
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, therefore, 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
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, 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
Elements of CA QMS (ISO 13485 or equivalent, 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 - 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, ISO 13845 or equivalent Class A & B products, can exclude design control, process control, inspection & testing For Class C, full QMS For Class D, full QMS PMS system Technical evaluation of sterilization process (if any) For LAR, importer, distributor: GDPMD Post-Market Surveillance System (PMS)
Distribution records Complaint records Adverse incident reporting (GHTF
recommendations - Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices) FSCA reporting (GHTF recommendations - Medical Devices Post Market Surveillance: Content of Field Safety Notices)
CONFORMITY ASSESSMENT
CA PROCESS & PARTIES INVOLVED
Conformity assessment is primarily the responsibility of the medical device manufacturer. However, 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, if necessary, withdraw authorization
CONFORMITY ASSESSMENT
Level of CA The level of CA is proportional to the risk associated with the device
Class Class A, Class A(S) Class A(M) Class B Class C Class D QMS Est & maintain can excl design & dev control. Class A may be audited for special cases. For Class B, make available for audit Establish, maintain full QMS make available for audit PMS system Establish & maintain adverse event reporting procedure for audit. For Class A, audit may be required to investigate specific safety or regulatory concerns
C A Self declare B
I
Tech doc CSDT
S
DoC
K
Registration & licensing
Prepare, make available upon request. For Class B may be reviewed for conformity to EPSP Prepare & submit for review
Stop
Evaluation
Decision
Yes
Yes
Pay fee
B, C, 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.Application Form 2. Declaration of conformity 3. Certified QMS. If no, attestation by manufacturer Division 4. Simplified CSDT
LICENSING OF ESTABLISHMENTS
Establishment means a person/organization who is either a manufacturer, authorized representative (for foreign manufacturer), importer or distributor of medical devices, 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
Distributor
Distributor
Imported device
Locally-made device
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. It must maintain linkage with its foreign manufacturer and should be able to obtain the support of its foreign manufacturer whenever required. 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. 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, available in the Malaysian market
LICENSING OF ESTABLISHMENTS
Requirements Establishment details Appropriate authorization Procedures for; 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
Local manufacturer
Importer
Distributor
Distributor
Committees appointed by MDA - to assist in the performance of the functions of the Authority
Medical Device Control Division MINISTRY OF HEALTH MALAYSIA
(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
Who shall be responsible? Licensed local manufacturers or authorized rep What would be required? Submission of CSDT Submission of DoC Establishment, maintenance and making available of QMS & PMS documents for audit Upon approval, 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, EU, Canada, Australia, Japan. Otherwise, full assessment shall be done
ESTABLISHMENT LICENSING MEDICAL DEVICE REGISTRATION CAB REGISTRATION COMPETENCY REGISTRATION SERVICE PROVIDER REGISTRATION
Medical Device Control Division MINISTRY OF HEALTH MALAYSIA
Authorized representative
3-Oct-2011
30-Dec-2011
31-July-2012
31-Oct-2012
31-Oct-2014
Preparation & development of regulations, guidance documents & standards for the implementation of MD Act
Medical Device Control Division MINISTRY OF HEALTH MALAYSIA
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
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
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