GOOD DISTRIBUTION PRACTICE

FOR MEDICAL DEVICE (GDPMD)

Medical Device Industry Seminar

in conjunction with
17th MDPWG Meeting

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
CONTENTS
• Background
• GDPMD Model
• Requirement for GDPMD
• Contents of GDPMD

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

BACKGROUND

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
MEDICAL DEVICE SUPPLY-CHAIN
PLACEMENT ON-
POST-MARKET
MARKET

• Transportation • Traceability
• Storage & stock handling • Vigilance
• Distribution • FSCA
• Delivery • Maintenance & calibration
• Installation • Disposal
• Secondary assembly • Complaint handling
• …. • Return of medical devices
• ….

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

WHAT IS 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

WHY NEED GDPMD?
GDPMD?
• 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

GDPMD MODEL

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
GDPMD MODEL
FCA
QUALITY
MANAGEMENT
SYSTEM Management
responsibility
Internal
audits,
Resource
medical
management
device
complaints
Supply chain
& device
specific Comply with
Regulatory (services) regulatory
INPUT OUTPUT
requirements requirements

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

HOW COMPLEX/SIMPLE GDPMD IS?
• 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

REQUIREMENT FOR GDPMD

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
WHO WILL BE AFFECTED?
Foreign
manufacturer Local
manufacturer

Local
Importer authorized
representative Distributor

Distributor

Locally-manufactured
Imported medical devices medical devices
Importer Distributor

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

WHEN IS GDPMD REQUIRED?
Requirements for establishment Local Authorized
Importer Distributor
licensing 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
representative, importer and distributor
Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
ESTABLISHMENT LICENCE
• 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

ESTABLISHMENT (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

CONTENTS OF GDPMD

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
CONTENTS OF GDPMD
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

1) OBJECTIVE
• 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

2) SCOPE AND APPLICATION
• 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

3) DEFINITIONS
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

4) ORGANIZATION AND MANAGEMENT
• 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

5) QUALITY MANAGEMENT SYSTEM
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

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

5) QUALITY MANAGEMENT SYSTEM
• 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

5) QUALITY MANAGEMENT SYSTEM
• 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

5) QUALITY MANAGEMENT SYSTEM
• 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

6) ESTABLISHMENT RESPONSIBILITY
•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
6) ESTABLISHMENT RESPONSIBILITY
• 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

7) RESOURCE MANAGEMENT
• 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

7) RESOURCE MANAGEMENT
• 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
8) SUPPLY-CHAIN & DEVICE SPECIFIC
• 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

8) SUPPLY-CHAIN & DEVICE SPECIFIC
• 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

8) SUPPLY-CHAIN & DEVICE SPECIFIC
• 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
Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
8) SUPPLY-CHAIN & DEVICE SPECIFIC
• Control of non-
non-conforming medical devices
▫ 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
Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
8) SUPPLY-CHAIN & DEVICE SPECIFIC
• 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

8) SUPPLY-CHAIN & DEVICE SPECIFIC
• 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
9) SURVEILLANCE AND VIGILANCE
• 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
9) SURVEILLANCE AND VIGILANCE
• 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
9) SURVEILLANCE AND VIGILANCE
• 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
9) SURVEILLANCE AND VIGILANCE
• Preventive action
▫ 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

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

SAVINGS AND TRANSITIONAL
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
Medical Device Authority Malaysia ● http://www.mdb.gov.my ● mdb@mdb.gov.my
FOR YOUR ATTENTION.