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GGGGOODOODOODOOD DDDDISTRIBUTIONISTRIBUTIONISTRIBUTIONISTRIBUTION PPPPRACTICERACTICERACTICERACTICE FORFORFORFOR MMMMEDICALEDICALEDICALEDICAL DDDDEVICEEVICEEVICEEVICE (GDPMD)(GDPMD)(GDPMD)(GDPMD)

DDDD EVICEEVICEEVICEEVICE (GDPMD)(GDPMD)(GDPMD)(GDPMD) Medical Device Industry Seminar in conjunction with 17 t h

Medical Device Industry Seminar in conjunction with 17 th MDPWG Meeting

Seminar in conjunction with 17 t h MDPWG Meeting One World Hotel, Petaling Jaya 22 April

One World Hotel, Petaling Jaya 22 April 2013

AHMAD SHARIFF HAMBALI, MEDICAL DEVICE AUTHORITY MALAYSIA, Level 5, Menara Prisma, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya, MALAYSIA ● http://www.mdb.gov.my mdb@mdb.gov.my ● Tel: 603-88850600 ● Fax: 603-88850759/0760

CCCC ONTENTSONTENTSONTENTSONTENTS • Background • GDPMD Model • Requirement for GDPMD • Contents of GDPMD

CCCCONTENTSONTENTSONTENTSONTENTS

Background

GDPMD Model

Requirement for GDPMD

Contents of GDPMD

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

for GDPMD • Contents of GDPMD Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my

BACKGROUND

B ACKGROUND MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia , Level 5, Menara Prisma, Boulevard Plot
B ACKGROUND MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia , Level 5, Menara Prisma, Boulevard Plot

MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia, Level 5, Menara Prisma, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya, MALAYSIA ● http://www.mdb.gov.my mdb@mdb.gov.my ● Tel: 603-88850600 ● Fax: 603-88850759/0760

MMMM EDICALEDICALEDICALEDICAL DDDD EVICEEVICEEVICEEVICE SSSS UPPLYUPPLYUPPLYUPPLY --C--CCC HAINHAINHAINHAIN PLACEMENT

MMMMEDICALEDICALEDICALEDICAL DDDDEVICEEVICEEVICEEVICE SSSSUPPLYUPPLYUPPLYUPPLY--C--CCCHAINHAINHAINHAIN

PLACEMENT ON- MARKET POST-MARKET • Transportation • Traceability • Storage & stock handling • Vigilance
PLACEMENT ON-
MARKET
POST-MARKET
• Transportation
• Traceability
• Storage & stock handling
• Vigilance
• Distribution
• FSCA
• Delivery
• Maintenance & calibration
• Installation
• Disposal
• Secondary assembly
• ….
• Complaint handling
• Return of medical devices
• ….
Complaint handling • Return of medical devices • …. Medical Device Authority Malaysia ●
Complaint handling • Return of medical devices • …. Medical Device Authority Malaysia ●
Complaint handling • Return of medical devices • …. Medical Device Authority Malaysia ●

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

• Return of medical devices • …. Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
WWWW HATHATHATHAT ISISISIS GDPMD?GDPMD?GDPMD?GDPMD? • GDPMD specifies requirements for the control of activities in

WWWWHATHATHATHAT ISISISIS GDPMD?GDPMD?GDPMD?GDPMD?

GDPMD specifies requirements for the control of activities in medical device supply-chain

GDPMD requires establishment to demonstrate ability to maintain safety and performance of medical devices throughout the supply-chain

GDPMD ensures medical device safety and performance throughout the supply-chain

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

performance throughout the supply-chain Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
WWWW HYHYHYHY NNNN EEDEEDEEDEED GDPMDGDPMD?GDPMDGDPMD??? • To achieve the goal to protect public health and

WWWWHYHYHYHY NNNNEEDEEDEEDEED GDPMDGDPMD?GDPMDGDPMD???

To achieve the goal to protect public health and safety by ensuring safety & performance of medical devices

To provide a clear legal framework regarding the obligations of those in the supply-chain

To make those in the supply-chain responsible and accountable for the medical devices they are dealing with

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

medical devices they are dealing with Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my

GDPMD MODEL

GDPMD M ODEL MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia , Level 5, Menara Prisma, Boulevard
GDPMD M ODEL MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia , Level 5, Menara Prisma, Boulevard

MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia, Level 5, Menara Prisma, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya, MALAYSIA ● http://www.mdb.gov.my mdb@mdb.gov.my ● Tel: 603-88850600 ● Fax: 603-88850759/0760

GDPMDGDPMDGDPMDGDPMD MMMM ODELODELODELODEL FCA QUALITY MANAGEMENT SYSTEM Management responsibility Internal audits,

GDPMDGDPMDGDPMDGDPMD MMMMODELODELODELODEL

FCA QUALITY MANAGEMENT SYSTEM Management responsibility Internal audits, Resource medical management device
FCA
QUALITY
MANAGEMENT
SYSTEM
Management
responsibility
Internal
audits,
Resource
medical
management
device
complaints complaints
Supply chain
& device
specific
Regulatory
INPUT
(services)
OUTPUT
requirements
Comply with
regulatory
requirements
Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
HHHH OWOWOWOW CCCC OMPLEXOMPLEXOMPLEXOMPLEX /S/S/S/S IMPLEIMPLEIMPLEIMPLE GDPMDGDPMDGDPMDGDPMD ISISISIS ???? •

HHHHOWOWOWOW CCCCOMPLEXOMPLEXOMPLEXOMPLEX/S/S/S/SIMPLEIMPLEIMPLEIMPLE GDPMDGDPMDGDPMDGDPMD ISISISIS????

Depends on:

the size and structure of establishment;

the processes employed; and

the type of medical devices dealt with

No uniformity in the structure of quality systems or documentation

To be certified by CAB

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

• To be certified by CAB Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my

REQUIREMENT FOR GDPMD

R EQUIREMENT FOR GDPMD MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia , Level 5, Menara Prisma,
R EQUIREMENT FOR GDPMD MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia , Level 5, Menara Prisma,

MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia, Level 5, Menara Prisma, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya, MALAYSIA ● http://www.mdb.gov.my mdb@mdb.gov.my ● Tel: 603-88850600 ● Fax: 603-88850759/0760

WWWW HOHOHOHO WILLWILLWILLWILL BEBEBEBE AAAA FFECTEDFFECTEDFFECTEDFFECTED ???? Foreign Local manufacturer manufacturer

WWWWHOHOHOHO WILLWILLWILLWILL BEBEBEBE AAAAFFECTEDFFECTEDFFECTEDFFECTED????

Foreign Local manufacturer manufacturer Local Importer authorized representative Distributor Distributor
Foreign
Local
manufacturer
manufacturer
Local
Importer
authorized
representative
Distributor
Distributor

Imported medical devices Importer

Locally-manufactured medical devices Distributor

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

medical devices Distributor Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
WWWW HENHENHENHEN ISISISIS GDPMDGDPMDGDPMDGDPMD RRRR EQUIREDEQUIREDEQUIREDEQUIRED ???? Requirements for establishment

WWWWHENHENHENHEN ISISISIS GDPMDGDPMDGDPMDGDPMD RRRREQUIREDEQUIREDEQUIREDEQUIRED????

Requirements for establishment licensing Local Authorized Importer Distributor manufacturer Representative •
Requirements for establishment
licensing
Local
Authorized
Importer
Distributor
manufacturer
Representative
• Details of establishment
×
×
× ×
• Appropriate authorization
×
× ×
• Procedures for;
– Distribution records
×
×
× ×
– Complaint handling
×
×
× ×
– Adverse incident reporting
×
×
× ×
– Field safety corrective action
×
×
× ×
• List of medical devices
×
×
× ×
• QMS (ISO 13485 or equivalent)
×
• GDPMD
×
× ×
one … of the requirements for application of establishment license under Act 737 for authorized
one …
of the requirements for application of
establishment license under Act 737 for authorized
representative, importer and distributor

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

importer and distributor Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
EEEE STABLISHMENTSTABLISHMENTSTABLISHMENTSTABLISHMENT LLLL ICENCEICENCEICENCEICENCE • Act 737 Part III Chapter 1:

EEEESTABLISHMENTSTABLISHMENTSTABLISHMENTSTABLISHMENT LLLLICENCEICENCEICENCEICENCE

Act 737 Part III Chapter 1: Establishment licence Section 15: Requirement for establishment licence

15(1): No establishment shall import, export or place in the market any medical device unless it holds establishment licence

15(2): Fine for offence under 15(1) – RM200k or 3 years imprisonment or both

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

RM200k or 3 years imprisonment or both Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
EEEE STABLISHMENTSTABLISHMENTSTABLISHMENTSTABLISHMENT ( SECTION 2, A CT 737) “establishment” means - a) a person

EEEESTABLISHMENTSTABLISHMENTSTABLISHMENTSTABLISHMENT (SECTION 2, ACT 737)

“establishment” means -

a) a person who is either a manufacturer, importer, or distributor who is responsible for placing any medical device in the market but does not include a retailer; and

b) an authorized representative appointed by a

manufacturer having a principal place of business

outside Malaysia, and such person and authorized representative being:

(A)

a person domiciled or resident in Malaysia; or

(B)

a firm or company constituted under the laws of Malaysia, and carrying on business or practice principally in Malaysia

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

or practice principally in Malaysia Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my

CONTENTS OF GDPMD

C ONTENTS OF GDPMD MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia , Level 5, Menara Prisma,
C ONTENTS OF GDPMD MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia , Level 5, Menara Prisma,

MEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia, Level 5, Menara Prisma, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya, MALAYSIA ● http://www.mdb.gov.my mdb@mdb.gov.my ● Tel: 603-88850600 ● Fax: 603-88850759/0760

CCCC ONTENTSONTENTSONTENTSONTENTS OFOFOFOF GDPMDGDPMDGDPMDGDPMD 1) OBJECTIVE 2) SCOPE AND APPLICATION 3) DEFINITIONS 4)

CCCCONTENTSONTENTSONTENTSONTENTS OFOFOFOF GDPMDGDPMDGDPMDGDPMD

1) OBJECTIVE 2) SCOPE AND APPLICATION 3) DEFINITIONS 4) ORGANIZATION AND MANAGEMENT 5) QUALITY MANAGEMENT SYSTEM 6) MANAGEMENT RESPONSIBILITY 7) RESOURCE MANAGEMENT 8) SUPPLY CHAIN AND DEVICE SPECIFIC 9) VIGILANCE AND CORRECTIVE ACTION

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

9) VIGILANCE AND CORRECTIVE ACTION Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
1)1)1)1) OOOO BJECTIVEBJECTIVEBJECTIVEBJECTIVE • To ensure the quality, safety and performance of medical device in

1)1)1)1)

OOOOBJECTIVEBJECTIVEBJECTIVEBJECTIVE

To ensure the quality, safety and performance of medical device in the supply chain

These include, but are not limited to, product sourcing, procurement, transportation, delivery, storage, installation, commissioning, service and maintenance, calibration, after sales service

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

calibration, after sales service Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
2)2)2)2) SSSS COPECOPECOPECOPE AAAA NDNDNDND AAAA PPLICATIONPPLICATIONPPLICATIONPPLICATION • Applicable to those

2)2)2)2)

SSSSCOPECOPECOPECOPE AAAANDNDNDND AAAAPPLICATIONPPLICATIONPPLICATIONPPLICATION

Applicable to those involved in trade and distribution of medical device:

Authorized representatives,

Importers, and

Distributors

Manufacturers are not covered

Requirement that is not applicable need not to be implemented but need to be justified

The term “as appropriate” or “as applicable” is used to qualify a requirement that is deemed to be “appropriate” or “applicable” unless it is justified otherwise

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

unless it is justified otherwise Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
3)3)3)3) DDDD EFINITIONSEFINITIONSEFINITIONSEFINITIONS Provide definitions of terms used in this document active medical

3)3)3)3)

DDDDEFINITIONSEFINITIONSEFINITIONSEFINITIONS

Provide definitions of terms used in this document

active medical device adverse effect adverse event customer complaint distribution distributor field corrective action (FCA) import importer installation qualification (IQ) place in the market packaging primary package

sales agent secondary assembly

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

package sales agent secondary assembly Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
4)4)4)4) OOOO RGANIZATIONRGANIZATIONRGANIZATIONRGANIZATION ANDANDANDAND MMMM ANAGEMENTANAGEMENTANAGEMENTANAGEMENT •

4)4)4)4)

OOOORGANIZATIONRGANIZATIONRGANIZATIONRGANIZATION ANDANDANDAND MMMMANAGEMENTANAGEMENTANAGEMENTANAGEMENT

Define the organization structure with the aid of an organizational chart and indicate the responsibility, authority and interrelationship of all key personnel;

Define the duties and responsibilities for every level of the supply chain;

Ensure managerial and technical personnel have the authority and resources needed to carry out their duties; and

Set up and maintain quality system, identify and correct any deviation

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

identify and correct any deviation Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
5)5)5)5) QQQQ UALITYUALITYUALITYUALITY MMMM ANAGEMENTANAGEMENTANAGEMENTANAGEMENT SSSS YSTEMYSTEMYSTEMYSTEM General

5)5)5)5)

QQQQUALITYUALITYUALITYUALITY MMMMANAGEMENTANAGEMENTANAGEMENTANAGEMENT SSSSYSTEMYSTEMYSTEMYSTEM

General requirements

establish, document and implement QMS and maintain its effectiveness;

identify processes and their application;

determine sequence and interaction of processes;

determine criteria and methods to ensure effectiveness of operation and control of processes;

ensure availability of resources and information to support operation and monitoring of processes;

monitor, measure and analyze processes;

implement actions to achieve planned results and maintain the effectiveness of processes;

manage the processes; and

identify and control outsourced processes

and • identify and control outsourced processes Medical Device Authority Malaysia ●

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

5)5)5)5) QQQQ UALITYUALITYUALITYUALITY MMMM ANAGEMENTANAGEMENTANAGEMENTANAGEMENT SSSS YSTEMYSTEMYSTEMYSTEM •

5)5)5)5)

QQQQUALITYUALITYUALITYUALITY MMMMANAGEMENTANAGEMENTANAGEMENTANAGEMENT SSSSYSTEMYSTEMYSTEMYSTEM

Documentation requirements

Establish, implement and maintain documented requirements, procedures and activities:

distributor manual comprising profile, operations, compliance to regulations and regulatory obligations; documents to ensure effective planning, operation and control of processes; records; and documents required by statutory requirements

Establish and maintain file containing documents defining product specifications and installation qualifications (if applicable) for each type of medical device, and define complete distribution process and, if applicable, installation and servicing

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

applicable, installation and servicing Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
5)5)5)5) QQQQ UALITYUALITYUALITYUALITY MMMM ANAGEMENTANAGEMENTANAGEMENTANAGEMENT SSSS YSTEMYSTEMYSTEMYSTEM •

5)5)5)5)

QQQQUALITYUALITYUALITYUALITY MMMMANAGEMENTANAGEMENTANAGEMENTANAGEMENT SSSSYSTEMYSTEMYSTEMYSTEM

Distributor Manual

Establish and maintain distributor manual that contains:

scope, including details of, and justification for any exclusion and/or non-application; medical device and their status of compliance; documented procedures, or reference to them; and information regarding:

premises where activities are conducted; personnel conducting the activities; addressing the regulatory requirements; and medical device and the registration holder

Control of documents

Establish a documented procedure for the control of documents

Regular review of documents

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

▫ Regular review of documents Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
5)5)5)5) QQQQ UALITYUALITYUALITYUALITY MMMM ANAGEMENTANAGEMENTANAGEMENTANAGEMENT SSSS YSTEMYSTEMYSTEMYSTEM • Control

5)5)5)5)

QQQQUALITYUALITYUALITYUALITY MMMMANAGEMENTANAGEMENTANAGEMENTANAGEMENT SSSSYSTEMYSTEMYSTEMYSTEM

Control of records

Establish and maintain records that are legible, readily identifiable and retrievable;

Establish documented procedure to define controls for identification, storage, protection, retrieval, retention time and disposition of records; and

Retain records for a period of time specified by regulatory requirements; or at least equivalent to the lifetime of the medical device product as defined by the manufacturer; whichever is the longest

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

manufacturer; whichever is the longest Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
6)6)6)6) EEEE STABLISHMENTSTABLISHMENTSTABLISHMENTSTABLISHMENT RRRR ESPONSIBILITYESPONSIBILITYESPONSIBILITYESPONSIBILITY

6)6)6)6)

EEEESTABLISHMENTSTABLISHMENTSTABLISHMENTSTABLISHMENT RRRRESPONSIBILITYESPONSIBILITYESPONSIBILITYESPONSIBILITY

Responsibility and authority

Define, document and communicate responsibilities and authorities Establish interrelation between all personnel involved in works affecting quality

Designated person

Appoint designated person with defined responsibility and authority Ensure establishment, implementation and maintenance of QMS Report performance to top management Ensure awareness on obligations to comply with requirements Liaise with external parties on GDPMD matters

Management review

review QMS for continued effectiveness maintain records of management reviews

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

maintain records of management reviews Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
6)6)6)6) EEEE STABLISHMENTSTABLISHMENTSTABLISHMENTSTABLISHMENT RRRR ESPONSIBILITYESPONSIBILITYESPONSIBILITYESPONSIBILITY

6)6)6)6)

EEEESTABLISHMENTSTABLISHMENTSTABLISHMENTSTABLISHMENT RRRRESPONSIBILITYESPONSIBILITYESPONSIBILITYESPONSIBILITY

Review input

Results of audits, customer feedback, process performance and product conformity, preventive and corrective actions, follow-ups from previous reviews, changes affecting QMS, recommendations for improvements

Review output

Decisions and actions related to improvement of the effectiveness of QMS, improvement of medical device related to customer requirements, resource needs

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

customer requirements, resource needs Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
7)7)7)7) RRRR ESOURCEESOURCEESOURCEESOURCE MMMM ANAGEMENTANAGEMENTANAGEMENTANAGEMENT • Personnel ▫ Competent,

7)7)7)7)

RRRRESOURCEESOURCEESOURCEESOURCE MMMMANAGEMENTANAGEMENTANAGEMENTANAGEMENT

Personnel

Competent, knowledgeable, skilled and experienced related to the job

Training, competency and awareness

Determine necessary competence

Provide training & evaluate

Maintain records

Infrastructure

Buildings, workspace, workshop

Measuring and test equipment

Supporting services (as applicable) for proper conservation and distribution of medical devices

Maintenance activities and records (as applicable)

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

activities and records (as applicable) Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
7)7)7)7) RRRR ESOURCEESOURCEESOURCEESOURCE MMMM ANAGEMENTANAGEMENTANAGEMENTANAGEMENT • Work environment ▫ Determine

7)7)7)7)

RRRRESOURCEESOURCEESOURCEESOURCE MMMMANAGEMENTANAGEMENTANAGEMENTANAGEMENT

Work environment

Determine & manage work environment

Establish requirements for health, cleanliness, clothing

Establish procedures/instructions to control environment

Control of contaminated or potentially contaminated medical devices, work environment or personnel

Cleanliness

Requirement for cleaning of premises

Maintain records

Pest control

Requirement for pest control programme

Maintain records

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

control programme ▫ Maintain records Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
8)8)8)8) SSSS UPPLYUPPLYUPPLYUPPLY --C--CCC HAINHAINHAINHAIN &&&& DDDD EVICEEVICEEVICEEVICE SSSS

8)8)8)8)

SSSSUPPLYUPPLYUPPLYUPPLY--C--CCCHAINHAINHAINHAIN &&&& DDDDEVICEEVICEEVICEEVICE SSSSPECIFICPECIFICPECIFICPECIFIC

Authorization

Appropriate authorization

Written agreement

Communication channels

Establish and maintain effective communication channels and feedback mechanisms with the relevant party

Manage and communicate with users, public and Authority on pre-market and post-market matters

Establish and maintain effective communication with manufacturer for effective dissemination of updated information,

Establish feedback mechanism with users and public for collecting comments and complaints from users and public, and providing maintenance services to the users

Receipt of stock

Verify medical devices received meet the requirements,

Records of verification

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

▫ Records of verification Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
8)8)8)8) SSSS UPPLYUPPLYUPPLYUPPLY --C--CCC HAINHAINHAINHAIN &&&& DDDD EVICEEVICEEVICEEVICE SSSS

8)8)8)8)

SSSSUPPLYUPPLYUPPLYUPPLY--C--CCCHAINHAINHAINHAIN &&&& DDDDEVICEEVICEEVICEEVICE SSSSPECIFICPECIFICPECIFICPECIFIC

Storage and stock handling

o

Identify and provide suitable and adequate storage

o

Maintain updated distribution records

o

Establish precautions and control to prevent deterioration or damage

Mark and restrict access to quarantine area

Store medical device with special risks in dedicated area

Identify damaged medical device and withdraw from usable stock

Stock rotation

Establish stock rotation system

Separate, label and dispose expired medical devices

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

and dispose expired medical devices Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
8)8)8)8) SSSS UPPLYUPPLYUPPLYUPPLY --C--CCC HAINHAINHAINHAIN &&&& DDDD EVICEEVICEEVICEEVICE SSSS

8)8)8)8)

SSSSUPPLYUPPLYUPPLYUPPLY--C--CCCHAINHAINHAINHAIN &&&& DDDDEVICEEVICEEVICEEVICE SSSSPECIFICPECIFICPECIFICPECIFIC

Delivery to customers

verify medical device is accompanied by relevant and applicable documentation

ensure designated medical devices are only sold and/or distributed to persons or entities that are entitled to acquire such medical devices

provide documentation to be supplied to customers

keep the record of delivery transactions

obtain relevant conditions for storage, transportation, installation, testing and commissioning, manuals, spare parts list and other relevant documentation to be provided to customer

ensure the delivery adhere to the conditions specified by the manufacturer

establish adequate and specialized methods of delivery

ensure medical devices with special risks of abuse, fire or explosion are stored in safe, dedicated and secure areas, and transported in safe, dedicated and secure containers and vehicles

in safe, dedicated and secure containers and vehicles Medical Device Authority Malaysia ●

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

8)8)8)8) SSSS UPPLYUPPLYUPPLYUPPLY --C--CCC HAINHAINHAINHAIN &&&& DDDD EVICEEVICEEVICEEVICE SSSS

8)8)8)8)

SSSSUPPLYUPPLYUPPLYUPPLY--C--CCCHAINHAINHAINHAIN &&&& DDDDEVICEEVICEEVICEEVICE SSSSPECIFICPECIFICPECIFICPECIFIC

ControlControlControlControl ofofofof nonnon-nonnon--conforming-conformingconformingconforming medicalmedicalmedicalmedical devicesdevicesdevicesdevices

establish documented procedures for handling of returned medical device which shall be treated as a non-conforming medical device;

ensure medical device which does not comply with the regulation is identified and controlled to prevent its unintended delivery and use

deal with non-conforming medical device by:

a) by eliminating the detected non-conformity; and b) by authorising its delivery and use under concession;

ensure that non-conforming medical device is delivered and used by concession only if regulatory requirements and manufacturer’s instruction are met

maintain records of the nature of non-conformities and any subsequent actions taken, including concessions

take action appropriate to the effects, or potential effects, of the non-conformity when non-conforming medical device is detected after delivery

non-conforming medical device is detected after delivery Medical Device Authority Malaysia ●

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

8)8)8)8) SSSS UPPLYUPPLYUPPLYUPPLY --C--CCC HAINHAINHAINHAIN &&&& DDDD EVICEEVICEEVICEEVICE SSSS

8)8)8)8)

SSSSUPPLYUPPLYUPPLYUPPLY--C--CCCHAINHAINHAINHAIN &&&& DDDDEVICEEVICEEVICEEVICE SSSSPECIFICPECIFICPECIFICPECIFIC

Disposal of medical devices

Establish procedure for disposal

Segregate medical device for disposal

Maintain records

Traceability

Maintain records providing traceability of medical devices

Retain records

Identify all parties in supply chain

Establish and document traceability throughout distribution channel

Tracking of specific medical devices

Track the high-risk medical devices down to patient level

If tracking to patient level is not possible, tracking should be done :

down to the healthcare facility level; and

on the date it was put into service or implanted into a patient, out of service or for an implanted device, the date it was explanted.

Submit surveillance reports on high risk medical devices at least once a year

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

medical devices at least once a year Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
8)8)8)8) SSSS UPPLYUPPLYUPPLYUPPLY --C--CCC HAINHAINHAINHAIN &&&& DDDD EVICEEVICEEVICEEVICE SSSS

8)8)8)8)

SSSSUPPLYUPPLYUPPLYUPPLY--C--CCCHAINHAINHAINHAIN &&&& DDDDEVICEEVICEEVICEEVICE SSSSPECIFICPECIFICPECIFICPECIFIC

Specific requirements for active medical devices

establish and maintain documented procedures and work instructions for performing installation, testing and commissioning and maintenance activities in accordance with MS 2058:2009 and any other requirements as specified

Calibration and maintenance of test equipment

Establish documented procedures to perform and verify calibration and maintenance of test equipment

Ensure equipment used for testing, maintenance is calibrated;

Maintain calibration and maintenance service records

Outsourced activities

Control outsourced processes

Establish criteria to ensure conformance to requirements

Audit supplier (if not certified to GDPMD)

Develop written agreement

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

GDPMD) ▫ Develop written agreement Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
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Medical device complaints

Establish and implement a documented procedure for handling complaints

Complaints and other information concerning potentially defective and counterfeit medical devices shall be reviewed

Complaint concerning a defective medical device shall be recorded and thoroughly investigated to identify the origin or reason for the complaint;

Maintain records of complaint, investigation and actions taken

where necessary, appropriate follow-up action should be taken after investigation and evaluation of the complaint.

Develop a system by which complaints, response received from the manufacturer, or the results of the investigation are shared with all the relevant parties

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

shared with all the relevant parties Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
9)9)9)9) SSSS URVEILLANCEURVEILLANCEURVEILLANCEURVEILLANCE ANDANDANDAND VVVV IGILANCEIGILANCEIGILANCEIGILANCE •

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Distribution records

Document all activities relating to the distribution of medical devices including all applicable receipts, storage, delivery and disposal

the records shall contain at least contact infromation of the manufacturer, authorised representative (AR), importer, exporter, distributor and customer and the identifier, including the identifier of any medical device that is part of a medical device group

Field corrective action (FCA)

Establish procedures for handling of FCA

Define responsibilities for planning, conducting and reporting of corrective actions in the procedure

Establish recall or withdrawal procedure

Inform Authority prior to execution of FCA

Inform all customers

Inform overseas counterparts if the medical devices are exported

Request that the recalled medical devices be removed immediately from usable stock

Maintain records

Recall

Establish a documented procedure in accordance with requirements

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

in accordance with requirements Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
9)9)9)9) SSSS URVEILLANCEURVEILLANCEURVEILLANCEURVEILLANCE ANDANDANDAND VVVV IGILANCEIGILANCEIGILANCEIGILANCE •

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Mandatory Problem Reporting

Establish documented procedure for mandatory problem reporting in accordance with requirements as

Internal audits

Establish and maintain a documented procedure, defining the responsibilities and requirements for planning and conducting audits and reporting of the results and the audit records;

Plan an audit programme

Define the audit criteria, scope, frequency and methods;

Conduct internal audits at planned intervals

Corrective action

Take corrective actions for any non-conformities and eliminate their causes

Establish a documented procedure to define requirements for

reviewing and determining the causes of non-conformities;

evaluating the need for action to ensure non-conformities do not recur;

determining and implementing action needed

recording of the results of any investigation and of action taken

reviewing the corrective action taken and its effectiveness

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

action taken and its effectiveness Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
9)9)9)9) SSSS URVEILLANCEURVEILLANCEURVEILLANCEURVEILLANCE ANDANDANDAND VVVV IGILANCEIGILANCEIGILANCEIGILANCE •

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PreventivePreventivePreventivePreventive actionactionactionaction

Determine proactive action to eliminate the causes of potential non-conformities; and

Establish a documented procedure to define requirements for:

determining potential non-conformities and their causes, evaluating the need for action to prevent occurrence of non-conformities, determining and implementing action needed, recording of the results of any investigations and of action taken, and reviewing preventive action taken and its effectiveness

reviewing preventive action taken and its effectiveness Medical Device Authority Malaysia ●

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

SSSS AVINGSAVINGSAVINGSAVINGS ANDANDANDAND TTTT RANSITIONALRANSITIONALRANSITIONALRANSITIONAL Act 737 Part VI: General

SSSSAVINGSAVINGSAVINGSAVINGS ANDANDANDAND TTTTRANSITIONALRANSITIONALRANSITIONALRANSITIONAL

Act 737 Part VI: General Section 80: Savings and transitional

80(1): A person who has imported, exported or place in the market any medical device prior to appointed date of the Act shall apply for registration of medical device within 24 months from the appointed date

80(2): A person who has imported, exported or place in the market any medical device and intend to continue shall apply for establishment licence within 12 months from the appointed date

80(3): A person in 80(1) or 80(2) may continue to import, export or place in the market the medical device pending determination of application

the medical device pending determination of application Medical Device Authority Malaysia ●

Medical Device Authority Malaysia http://www.mdb.gov.my mdb@mdb.gov.my

FORFORFORFOR YOURYOURYOURYOUR ATTENTION.ATTENTION.ATTENTION.ATTENTION.
FORFORFORFOR YOURYOURYOURYOUR ATTENTION.ATTENTION.ATTENTION.ATTENTION.

FORFORFORFOR YOURYOURYOURYOUR ATTENTION.ATTENTION.ATTENTION.ATTENTION.