UPDATE:

August 1st 2014

GUIDE FOR THE IMPLEMENTATION OF GOOD DISTRIBUTION PRACTICES FOR MEDICAL DEVICE (GDPMD)
Provision no.
2

3
4

10

11

12

13

Provision

Requirements

Recommendations/Notes

Scope and application

GDPMD is applicable to Authorized representatives of foreign manufacturers, importers and distributors, IT IS Manufacturers will be required to be ISO 13485 certified.
NOT APPLICAPLE to manufacturers and retailers of medical devices.
Justification has to be provided if a GDPMD requirement is not applicable
It is recommended to document these justification in the Quality Manual or
Regulatory Compliance manual
GDPMD certification to be conducted by an approved Conformity Assessment Body (CAB)
A list of approved CAB's is available here:
http://www.mdb.gov.my/mdb/index.php?option=com_content&task=view&id
=185&Itemid=138
Definitions
"Authority" means the Medical Device Authority (MDA)
MDA is a division in the Ministry of Health Malaysia (MOH) in charge of
regulating medical device and its industry players in the country.
Organization
Define the organization structure, duties and responsibilities
Organizational chart with names and positions showing interrelationship of all
key personnel. For each position, develop job descriptions with title, authorities
and responsibilities.
Setup AND maintain GDPMD regulatory compliance system
It is stated here that the organization shall maintain the effectiveness of the
regulatory compliance system by implementing appropriate CAPA system
GDPMD Regulatory Compliance Establish, document and implement GDPMD RCS
System is generally described in the Regulatory Compliance Manual
System (RCS) -General
Identify proccesses needed for the GDPMD
Define a 3 layers process map showing interaction: management, realization and
support
Determine criteria and methods needed for the control of these processes
process matrix with process name, pilot, activities, indicators, review frequency
and effectiveness criteria (targets)
Ensure resources availability
for each process, resources needs shall be reviewed on a regular basis (during
management reviews, meetings,etc)
Monitor, measure and analyze these processes
analyze process matrix indicators on a regular basis (it is a good practice to
review quarterly)
Implement actions to achieve planned results and maintain effectiveness
implement CAPA system
Identify and control outsourced processes
ie: sterilization, packaging... a close monitoring of these processes is also
required.
Documentation
Regulatory Compliance manual
equivalent to "Quality Manual" for ISO13485.
Describe clearly which medical devices the establishment is dealing with and
their status of compliance (in Malaysia and abroad)
make a reference to GDPMD RCS procedures, other documents/records needed
for compliance.
scope of GDPMD RCS including details of and justification fo any exclusion and/or
non-application
Specific information related to premises, personnel and medical device
conformity assessment/registration holder
Detailed description on how the relevant and applicable regulatory requirements are adressed for each
Suggestion here is to prepare a checklist with requirements, applicability and
medical device specified in the scipe of the GDPMD RCS
reference documents provided as a compliance objective evidence
For each type of MD, the establishment shall maintain a file.
Similar to DMR (Device Master Record) for a manufacturer, this should include all
the specifications required for proper handling of a device by the establishment
(it is device specific)..
Document control
Document control procedure
establish a procedure on how to control documents (incl. numbering, structure,
archiving, disposition, etc)
prepared, approved, signed by an authorized person
establish a signature matrix including levels of authorization for each type of
document
prevent unintended use of superseded version
include change control in document control procedure
establish and maintain records of GDPMD RCS
establish an instruction for Good documentation practices
define controls for the identification, storage, protection, retrieval, retention time and disposition
establish a procedure for control of records (incl. list of GDPMD records)
records retention
determine retention time for each type of record
Responsibilities and authorities responsibilities and authorities to be documented and communicated
it is a good practice to have responsibilities and authorities documented in a
specific section for each procedure
interrelations between all personnel
Organization chart (including handling personnel)
Designated person
Appoint designated person
Equivalent to Management representative. This is generally the person having a
good knowledge of GDPMD requirements (Quality Manager, Quality Engineer,
QA executive, etc)
Suggestion: a letter of appoinment should be issued to the DP.
Management review
Management review
A review of the GDPMD RCS shall be organized on a regular basis (ie.quarterly)
where the management team will review the whole system to ensure
compliance. Minutes of the management review shall be recorded.
Review Input
results of internal and external audit
management review shall include all of the review input

Review Output

Personnel

14

Training

15

Infrastrucure

16

Work environment

17

Cleanliness and pest control

18

Authorization

19

Communication channel

customer complaint/feedback
GDPMD regulatory compliance system and medical device compliance
surveillance and vigilancee activities including field safety corrective actions, advisory notes, recalls and
adverse event/incident reporting
feedback from manufacturer
feedback and directives from the authority
status of preventive and corrective actions
follow-up actions from previous management review
changes that could affect the GDPMD
recommendatios for compliance
corrective and preventive actions required
effectiveness of GDPMD and its compliance with Malaysian medical device regulatory requirements
resource needs
Personnel shall be competent and possesses appropriate professional knowledge,education, training, skills
and experience.
Personnel providing post market technical support for active devices shall conform to the requirements
and/or standards recognized by the authority
Adequate number of competent personnel involved in the supply chain to ensure quality, safety and
performance
Determine the necessary competences
Provide training
Evaluate training effectiveness
Maintain training records, skills and experience
Ensure premises ad equipment used are suitable, secure, safe and adequate
Establish documented requirements

management review shall include any decisions and actions related to the review
output
Employee Individual file shall include CV, certificates,etc...

Technicians performing after sales service shall be trained to execute

maintenance activities as per manufacturer specifications and local regulations.
Adequate means enough resources to run the operations safely and efficiently.
This will depend on the company business requirements.
eg: during annual performance reviews
Suggestion: develop training needs based on performance review outcome
Training evaluation form with effectiveness evaluation section
Training records shall be part of the GDPMD system
Proper space for storage and handling of the product
Suggestion: Establish work instruction for maintaning the premises and
equipment, including their frequencies
Maintain records of maintenance activities
Records shall be part of the GDPMD system
Determine and manage work environment needed
eg. Special work environment such as controlled room needed?
Establish documented requirements for health, cleanliness and clothing of personnel if contact between such Suggestion: Establish work instruction for health, cleanliness and dressing of
personnel and medical devices or work environment that could adversely affect quality of medical devices
personnel
Establish documented procedure or work instructions to monitoring and control conditions for work
Establish procedure/work instruction for work environment monitoring
environment that could adversely affect quality of medical devices
(Temperature, Humidity)
Ensure all personnel who are required to work temporarily under special environment that could adversely This requirement can be included in procedure/work instruction for work
affect quality of medical devices are appropriately trained or supervised by a trained person
environment monitoring
Establish special arrangements and document the control of contaminated or potentially contaminated
This requirement can be included in procedure/work instruction for work
medical devices, work environment or personnel
environment monitoring
Establish documented requirements
Suggestion: Establish procedure/work instruction for cleaning of premises, pest
control program, including frequency and methods
Maintain records of cleaning
Cleaning records shall be part of the GDPMD system
Establish a pest control program
Suggestion: Establish procedure/work instruction for pest control program.
Pest control program can be managed internally or by pest control service
provider (eg. Installation of insect light trap (for flying insect) and installation of
rodent trap)
Maintain records of pest control program
Pest control records shall be part of the GDPMD system
Obtain required authorization to become authorized representative,importer or distributor
Suggestion: obtain letter of authorization from relevant party to become
authorized representative, importer or distributor.
Establish and maintain written agreement with relevant party
Written agreement shall be part of the GDPMD system (distribution agreement,
regulatory agreement, etc.)
Establish and maintain communication channel and feedback mechanisms with relevant party
Suggestion: create status report providing medical device feedback information
to relevant party (Post-Market Surveillance)
Manage and communicate with users, public and authority on medical devices dealing with
Establish and maintain efficient communication channel with manufacturers

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Communication channel

20

Receipt of stock

21

Storage and stock handling

22

Stock rotation

23

Delivery to customers

24

Control of nonconforming
medical devices including
returned medical devices

Establish feedback mechanism for collecting comments and complaints from users and public, to be
Suggestion: create complaint form (eg: 8D report)
forwarded to relevant party as applicable
Establish mechanism to provide information on maintenance services, including calibration, provision of spare suggestion: include in Manuals, IFU, leaflets,etc.
parts and other services, to the users
Establish and implement inspection/other activities to ensure medical device meets specified requirements Suggestion: Perform incoming inspection, create incoming inspection log
Maintain records of verification
Inspection records shall be part of the GDPMD system
Identify storage measures for specific medical devices and stored in accordance with manufacturer's
Suggestion: Establish procedure/work instruction for storage and stock handling
instructions
Provide suitable storage
Provide suitable storage area eg. Warehouse
Maintain updated distribution records of medical devices dealing with
Maintain distribution records of medical devices it deals with,including the make,
model, batch number, serial number and quantity.
Establish adequate precautions and control to prevent deterioation or damage of medical devices
Can be part of the procedure/work instruction for storage and stock handling
Quarantine status and quarantine area
Provide proper identification and quarantine area/storage for nonconform
products
Any system replacing physical quarantine should provide equivalent security
Storage for medical device presenting special risks of abuse, fire or explosion
Provide proper storage area for medical device presenting special risks of abuse,
fire or explosion
Identification and withdrawn of broken/damaged medical device from usable stock
Provide proper identification for broken/damaged medical device and make sure
the medical devices are withdrawn from usable stock (eg. Store in quarantine
area)
Establish stock rotation system
eg. First-In-First-Out (FIFO) system
Identification of expired medical device
Provide proper identification and storage area for medical device with a shelf-life
Dispose expired medical device
Verify that certificate of registration, license and other applicable documents and instructions for use (IFU) is
accompanied with registered medical device
Ensure that medical device bears all information needed
Ensure medical device should only be sold/distributed by designated persons or entities only
Provide proper documentation to customers
Keep record of delivery transaction
Obtain condition of storage, transportation, installation, testing and commissioning requirements, users and
service manual,spare part list and certificate from manufacturer and provide to customer
Ensure delivery of medical device adhere specified condition
Establish specialized method of delivery from the point of collection to the point of delivery
Ensure delivery of medical devices presenting special risks of abuse, fire or explosion are stored in safe, and
transported in safe conditions
Establish documented procedure

Refer to section Disposal of medical devices (clause 25)

Suggestion: create procedure/work instruction for delivery to customer
check whether all informations are available
suggestion: create list of approved distributor/customer
eg. : manuals, delivery notes with traceability information, etc
Records of delivery (eg. Delivery notes) shall be maintained
ensure all informations are obtained from manufacturer and provide to customer
eg.temperature control, special storage condition, etc.
suggestin: establish contract with forwarders
eg. Fire proof cabinet, etc.
Create control of nonconforming medical device procedure

Ensure nonconforming medical device is identified and controlled to prevent its unintended delivery and use To be included in the procedure
Define control and responsibilities and authorities for nonconforming medical device handling
Deal with nonconforming medical device with one or more of following ways:
- by taking action to eliminate detected nonconformity
- by authorizing delivery and use under concession
Ensure nonconforming medical device is delivered and used by concession only if regulatory requirements are
met
Maintain records of justification and identify person authorizing the concession

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26

27

28

29

Disposal of medical devices

Traceability

Maintain records

To be included in the procedure and form. The person authorizing concession

should be identified.
Records shall be part of GDPMD system

Take appropriate action when nonconforming medical device is detected after delivery

Implement Field Corrective Action if required. Refer to provision 40

Establish documented procedure

Create disposal of medical device procedure explaining how devices shall be

disposed (considering locl regulations).
Identify storage area (eg. Quarantine area)

Ensure, if the medical device have not been immediately sent for disposal, they shall be kept in clearly
segregated, safe and secured area and identified
Maintain records
Maintain updated records providing traceability of medical devices
Records retention

Ensure all parties involved in the supply chain shall be identifiable

Establish measures to ensure traceability of medical devices throughout distribution channels from
manufacturer/importer to the customer and to the patient
Records including expiry dates and batch records
Specific traceability
Establish tracking records for all implants
requirements for implantable If tracking is not possible for any individual medical devices, the tracking system is still required as follows:
medical devices
(i) to track the medical devices down to healthcare facility level
(ii) to keep track of the following:
- date of medical device was put into service/implanted into a patient
- date the device permanently retired from use or for an implanted medical device, the date it was implanted
Submit surveillance reports to authority at least once a year
Specific requirements for active Establish documented procedure and work instructions for performing installation, testing and
medical devices
commissioning and maintenance activities
Establish and maintain documented procedures, work environments and reference materials, tools and test
equipment and reference measurement procedures, for performing servicing activities including calibration,
repair, maintenance and verifying that they meet the regulatory requirements and applicable standards.

Outsourced activities

Establish documented requirements which contain acceptance criteria for installation, testing and
commissioning of medical device.
Establish installation qualification and maintain adequate installation and inspection instructions for medical
device requiring specified installation requirements, and where appropriate, test procedure
Ensure proper installation, testing and commissioning
Ensure equipment used for testing, maintenance and conservation of medical devices are calibrated or
verified at specific intervals
Ensure calibration and maintenance of test equipments conforms to applicable standards
maintain testing and commissioning, installation, calibration and maintenance service records.
Ensure control outsourced process within GDPMD scope
Establish requirements to ensure outsourced activities conform specified requirements
Ensure type and extent of control applied to supplier are dependent on impact on meeting the requirements
of GDPMD
ensure outsourced supplier is audited as part of establishment unless the supplier is already certified to
GDPMD covering the scope of outsourced activities
develop written agreements with outsourced party
Physically segregated from other medical devices to avoid any confusion

Records of disposal shall be part of GDPMD system

Maintain a list for customer/serial number of lot number
specify records retention period
- as specified in regulatory requirements, at least equivalent to lifetime of
medical device as defined by manufacturer of medical device,or no less than two
years from the date that medical device is shipped from establishment,
whichever is the longest.
identify the distributor, importer, manufacturer, authorized representative, etc.
create traceability record
Maintain a record for batch number/expiry date
create implant tracking record/log to include all informations needed

submit yearly report to MDA

create installation, testing and commissioning and maintenance procedure and
work instructions (eg: MRI, XRay,etc..)

perfom installation qualification following the manufacturer protocol.

specify calibration or verification interval in work instruction

records should be part of GDPMD system

outsourced activities: eg. warehouse, sterilization, logistic, etc.
All outsouced activities should be closely monitored (auditing for example)

ensure outsourced supplier is audited

create agreement format and maintain records of agreement
identify segregation area

30

Counterfeit adulterate,
unwholesome and tampered
medical devices

31

Secondary assembly including Availability of information that describes characteristics of medical devices
Ensure all informations (instruction for use, maintenance activities, etc.) are
repackaging
available
Availability of documented procedures, documented requirements, work instructions and reference materials Ensure all documents are available during secondary assembly activities
and reference measurement procedures as necessary
The use of suitable equipment
packaging machine, label printer, etc.
Availability and use of monitoring and measuring devices
ensure suitable monitoring and measuring device are used
Implementation of monitoring and measurement activities
first piece inspection, statistical process control (SPC), etc.
Implementation of release of medical device, their delivery and post-delivery activities
final release inspection,etc.
Implementation of defined operations and packaging of medical devices
ensure packaging activities are according to packaging work instruction
Establish and maintain a record for each batch of medical devices that provides traceabilty and identifies the eg. Work order, tracking records
amount assembled and the amount approved for distribution
Ensure batch record shall be verified and approved by qualified personnel
suggestion: include responsibility of verification of batch record in final release
procedure
Assembly documents
Kept batch assembly records
maintain assembly records eg.work order, operator tracking record, etc.
Ensure assembly are made or completed at each time action is taken to trace significant activities of assembly eg. Verification by supervisor is needed after each assembly activities completed

32

inform the Authority and manufacturer immediately.

Record retention

33

Materials control

inform authority through http://www.mdb.gov.my

as specified in regulatory requirements, at least equivalent to lifetime of medical

device as defined by product owner of medical device,or no less than two years
from the date that medical device is shipped from establishment, whichever is
the longest.
For each delivery, incoming medical device are checked for integrity of package and seal, for correspondence perform incoming inspection, label verification, etc.
between delivery note and the supplier's label, and for compliance with quality specification
medical device with breached primary package are not used for secondary assembly
locate in proper segregation area
medical device in storage area are appropriately labeled
Identify properly (labelling, storage area, etc.)

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Materials control

34

Labelling

35

Good assembly practices

36

38

39
40

41

42
43

44
45

Appropriate procedures or measures are taken to assure identity of the contents of each packing of medical
device
Clearly identify bulk containers from which quantities of medical device that have been drawn
Placed medical device requiring special storage conditions in areas which are designed an equipped to
provide desired conditions
Continuously monitor and record storage and conditions
Express actual storage temperature quantitatively
the purchase, handling, and control of all packaging materials are accorded attention similar to that given to
starting materials
packaging materials are issued for use only by authorized personnel in accordance with documented
procedure
when setting up a program for packaging operations, particular attention is given to minimize risk if cross-
contamination, mix-ups or substitutions
different medical devices shall not be packaged in close proximity unless there is physical segregation
Ensure repackaged medical devices bear all original labelling (including IFU and any other information sheet
or leaflet, etc.) and all labelling information, except for quantity and distributor identity.
Check medical devices and materials used for assembly before use by a designated person for quantity,
identity and conformity with the packaging instructions.
Performed line clearance prior commencement of assembly operation
Check and record the correct performance of any printing operation which is carrried out separately or in the
course of packaging
Re-check printing by hand at regular intervals
Assembly equipment/apparatus are cleaned according to detailed and written procedures and stored only in
a clean and dry condition
Assembly equipment/apparatus do not present any hazard to the medical devices
Parts of assembly equipment/apparatus that come into contact with medical devices do not effect quality of
medical devices and present any hazard
Calibrate and check control environment at defined intervals and adequate records of calibration shall be
maintained.

Create procedure/work instruction

Conduct internal audits at planned intervals

Maintain records of audit and results
Take action to eliminate detected nonconformities and causes without undue delay
Establish documented procedure
Establish documented procedure

Internal audit plan should be created

Records of audit shall be part of GDPMD system
Action should be taken immediately
Create corrective action procedure and form.
Create preventive action procedure and form.
Suggestion: corrective action and preventive action procedure can be combined
in one procedure

create proper labeling/identification/storage area

eg. Medical device that needs temperature control
create storage and condition monitoring record
record storage temperature in storage and condition monitoring record
ensure material control activities are according to procedure/work instruction
include responsibility of issuing packaging material in procedure/work instruction
proper identification, segregation area
create proper segregation area
perform labelling inspection/verification
perform inspection. Medical device and material used should be inspected by
designated personnel only.
suggestion: include line clearance activity in work instruction
perform label verification

perform cleaning according to cleaning procedure

calibration interval and checking of control environment should be specified in

procedure or etc.
records should be maintained
Quality control
Finished medical device assessment shall embrace all relevant factors,including assembly conditions, a review create final release procedure, inspection criteria, etc.
of packaging documentation, compliance with finished medical device specification and visual examination of Perform inspection/verification according to specified requirement
final finished pack
Process of secondary assembly shall not compromise conformity of medical device to essential principles of
safety and performance
Medical device complaints
Establish documented procedure
Create complaint handling procedure
Review all complaints and other information concerning potentially defective and counterfeit medical
To be included in complaint procedure and form (review section)
devices, including description of action to be taken and reporting to relevant parties, where appropriate
Record any complaint and investigate to identify origin or the reason for complaint
Create complaint form and complaint log
Maintain records of complaints, investigation and action taken
Create complaint form
Follow-up action should be taken after investigation and evaluation of complaint, where necessary
To be included in complaint form
Distribution records
Document all activities relating to distribution
Maintain distribution records including receipts, storage, delivery and disposal
FCA and FSN
Establish documented procedure
Create procedure for handling of FCA and FSN
Define responsibilities for planning, conducting and reporting of corrective actions in procedure
Include responsibilities in procedure
Establish writing a recall/withdrawal procedure in consultation with manufacturer
Establish recall procedure
Inform authority prior execution of FCA and FSN
Any adverse event shall be reported through mdb website:
http://www.mdb.gov.my/mdb/index.php?option=com_content&task=view&id=
19&Itemid=115
Inform customers to whom medical device was distributed with appropriate degree of urgency
customer should be informed immediately
Inform overseas counterparts on FCA and FSN if medical devices are exported
Communicate with overseas counterpart if medical devices are exported
Maintain records of action taken and approval by manufacturer and authority
Records shall be maintained
Recall
Establish documented procedure
Recommendation: Recall can be included in FCA procedure
Ensure the system comply with regulatory requirements
Manufacturer and/or authorized representative shall be informed in the event of recall
Inform Manufacturer and/or authorized representative
where recall is instituted by an entity other than manufacturer and/or authorized representative,
consult Manufacturer and/or authorized representative if recall is instituted by
consultation with manufacturer and/or authorized representative should, where possible, take place before other entity
recall is instituted
recall information shall be reported to the Authority
inform authority through http://www.mdb.gov.my
Progress of recall process should be recorded and a final report issued, which includes a reconcilliation
issue final report of recall process
between delivered and recovered quantities of products.
Mandatory problem reporting Establish documented procedure
Establish mandatory problem reporting procedure
Each incident report shall lead to a final report where corrective actions are applicable
create mandatory problem report form
Internal audits
Establish documented procedure
Define responsibilities,requirements for planning and conducting audits and
reporting of result and maintenance of audit records.
Plan an audit program
Establish audit plan
Define audit criteria, scope, frequency and methods
audit criteria, scope, frequency and methods should be included in the procedure

Corrective action
Preventive action