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 mdb@mdb.gov.my 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

RISK-BASED CLASSIFICATION & REGULATORY CONTROL

A classification of medical devices based on risk associated with the vulnerability of the human body, 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, 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

Risk Level Low

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

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

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

D Product design & manufacturing control

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

Prepare, sign & submit for review

Perform according to requirements

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

WHAT DO WE NEED TO IMPLEMENT THE REGULATORY SYSTEM?

Legal support, ie the Acts Subsidiary legislations & guidance documents Medical Device Authority & organization Registration & licensing system
Internal processes & procedures Register, database & resource center Forms Criteria Procedures

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

MEDICAL DEVICE REGISTRATION ROUTES

Stop No Medical device? B, C, D
Conformity Assessment By CAB or MDA 1. 2. Technical File ISO 13485 QMS

Stop

No No Qualified for abridged? OK? Yes Yes

1.Application Form 2. DC from Product Owner/Manufacturer 3.CSDT 4. Class B, C if Required- Clinical evidence Class C&D Clinical Evaluation

Evaluation

Decision

Yes

Grouping: Single System Kits Group

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

MEDICAL DEVICE REGISTER

Medical Device Control MINISTRY OF HEALTH MALAYSIA

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

Importer Authorized representative Local manufacturer

Distributor

Distributor

Imported device

Locally-made device

Relationship between different establishments

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

Good Distribution Practice for Medical Devices (GDPMD)

Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

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

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 - Chief Executive of the MDA - a representative of Min of Finance - a representative of Min of Health - not more than five persons appointed by the Minister, who have expertise and experience in medical device matters Functions of MDA To implement, enforce, consider and recommend reform to the medical device laws To perform the following - to regulate all matters - to provide consultancy & advisory service and any other services in relation to medical device, 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 - to assist in the performance of the functions of the Authority
Medical Device Control Division MINISTRY OF HEALTH MALAYSIA

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 AGs 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

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, 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, 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

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