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UPDATE: August 1st 2014   GUIDE FOR THE IMPLEMENTATION OF GOOD DISTRIBUTION PRACTICES FOR MEDICAL

UPDATE: August 1st 2014

 

GUIDE FOR THE IMPLEMENTATION OF GOOD DISTRIBUTION PRACTICES FOR MEDICAL DEVICE (GDPMD)

Provision no.

Provision

Requirements

 

Recommendations/Notes

 

2 Scope and application

GDPMD is applicable to Authorized representatives of foreign manufacturers, importers and distributors, IT IS NOT APPLICAPLE to manufacturers and retailers of medical devices.

Manufacturers will be required to be ISO 13485 certified.

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

 

3 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.

 

4 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

 

5 GDPMD Regulatory Compliance System (RCS) -General

Establish, document and implement GDPMD RCS

System is generally described in the Regulatory Compliance Manual

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.

 

6 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 medical device specified in the scipe of the GDPMD RCS

Suggestion here is to prepare a checklist with requirements, applicability and 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)

 

7 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

 

8 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)

 

9 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.

 

10 Management review

Management review

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.

A

 

11 Review Input

results of internal and external audit

management review shall include all of the review input

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

 

12 Review Output

corrective and preventive actions required

management review shall include any decisions and actions related to the review

output

effectiveness of GDPMD and its compliance with Malaysian medical device regulatory requirements

resource needs

 

13 Personnel

Personnel shall be competent and possesses appropriate professional knowledge,education, training, skills and experience.

Employee Individual file shall include CV, certificates,etc

Personnel providing post market technical support for active devices shall conform to the requirements and/or standards recognized by the authority

Technicians performing after sales service shall be trained to execute maintenance activities as per manufacturer specifications and local regulations.

Adequate number of competent personnel involved in the supply chain to ensure quality, safety and performance

Adequate means enough resources to run the operations safely and efficiently. This will depend on the company business requirements.

14 Training

 

Determine the necessary competences

eg: during annual performance reviews

Provide training

Suggestion: develop training needs based on performance review outcome

Evaluate training effectiveness

Training evaluation form with effectiveness evaluation section

Maintain training records, skills and experience

Training records shall be part of the GDPMD system

 

15 Infrastrucure

Ensure premises ad equipment used are suitable, secure, safe and adequate

Proper space for storage and handling of the product

Establish documented requirements

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

 

16 Work environment

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 personnel and medical devices or work environment that could adversely affect quality of medical devices

Suggestion: Establish work instruction for health, cleanliness and dressing of

 

personnel

Establish documented procedure or work instructions to monitoring and control conditions for work environment that could adversely affect quality of medical devices

Establish procedure/work instruction for work environment monitoring (Temperature, Humidity)

Ensure all personnel who are required to work temporarily under special environment that could adversely affect quality of medical devices are appropriately trained or supervised by a trained person

This requirement can be included in procedure/work instruction for work environment monitoring

Establish special arrangements and document the control of contaminated or potentially contaminated medical devices, work environment or personnel

This requirement can be included in procedure/work instruction for work environment monitoring

 

17 Cleanliness and pest control

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

 

18 Authorization

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.)

 

19 Communication channel

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

   

Establish feedback mechanism for collecting comments and complaints from users and public, to be forwarded to relevant party as applicable

Suggestion: create complaint form (eg: 8D report)

Establish mechanism to provide information on maintenance services, including calibration, provision of spare parts and other services, to the users

suggestion: include in Manuals, IFU, leaflets,etc.

20

Receipt of stock

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

21

Storage and stock handling

Identify storage measures for specific medical devices and stored in accordance with manufacturer's instructions

Suggestion: Establish procedure/work instruction for storage and stock handling

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)

22

Stock rotation

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

Refer to section Disposal of medical devices (clause 25)

23

Delivery to customers

Verify that certificate of registration, license and other applicable documents and instructions for use (IFU) is accompanied with registered medical device

Suggestion: create procedure/work instruction for delivery to customer

Ensure that medical device bears all information needed

check whether all informations are available

Ensure medical device should only be sold/distributed by designated persons or entities only

suggestion: create list of approved distributor/customer

Provide proper documentation to customers

eg. : manuals, delivery notes with traceability information, etc

Keep record of delivery transaction

Records of delivery (eg. Delivery notes) shall be maintained

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 all informations are obtained from manufacturer and provide to customer

Ensure delivery of medical device adhere specified condition

eg.temperature control, special storage condition, etc.

Establish specialized method of delivery from the point of collection to the point of delivery

suggestin: establish contract with forwarders

Ensure delivery of medical devices presenting special risks of abuse, fire or explosion are stored in safe, and transported in safe conditions

eg. Fire proof cabinet, etc.

24

Control of nonconforming medical devices including returned medical devices

Establish documented procedure

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

To be included in the procedure and form. The person authorizing concession should be identified. Records shall be part of GDPMD system

Maintain records

Take appropriate action when nonconforming medical device is detected after delivery

Implement Field Corrective Action if required. Refer to provision 40

25

Disposal of medical devices

Establish documented procedure

Create disposal of medical device procedure explaining how devices shall be disposed (considering locl regulations).

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

Identify storage area (eg. Quarantine area)

Maintain records

Records of disposal shall be part of GDPMD system

26

Traceability

Maintain updated records providing traceability of medical devices

Maintain a list for customer/serial number of lot number

Records retention

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.

Ensure all parties involved in the supply chain shall be identifiable

identify the distributor, importer, manufacturer, authorized representative, etc.

Establish measures to ensure traceability of medical devices throughout distribution channels from manufacturer/importer to the customer and to the patient

create traceability record

Records including expiry dates and batch records

Maintain a record for batch number/expiry date

27

Specific traceability requirements for implantable medical devices

Establish tracking records for all implants

create implant tracking record/log to include all informations needed

If tracking is not possible for any individual medical devices, the tracking system is still required as follows:

(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

submit yearly report to MDA

28

Specific requirements for active medical devices

Establish documented procedure and work instructions for performing installation, testing and commissioning and maintenance activities

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

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.

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

perfom installation qualification following the manufacturer protocol.

Ensure proper installation, testing and commissioning

Ensure equipment used for testing, maintenance and conservation of medical devices are calibrated or verified at specific intervals

specify calibration or verification interval in work instruction

Ensure calibration and maintenance of test equipments conforms to applicable standards

maintain testing and commissioning, installation, calibration and maintenance service records.

records should be part of GDPMD system

29

Outsourced activities

Ensure control outsourced process within GDPMD scope

outsourced activities: eg. warehouse, sterilization, logistic, etc.

Establish requirements to ensure outsourced activities conform specified requirements

All outsouced activities should be closely monitored (auditing for example)

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

ensure outsourced supplier is audited

develop written agreements with outsourced party

create agreement format and maintain records of agreement

30

Counterfeit adulterate, unwholesome and tampered medical devices

Physically segregated from other medical devices to avoid any confusion

identify segregation area

inform the Authority and manufacturer immediately.

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

31

Secondary assembly including repackaging

Availability of information that describes characteristics of medical devices

Ensure all informations (instruction for use, maintenance activities, etc.) are available

Availability of documented procedures, documented requirements, work instructions and reference materials and reference measurement procedures as necessary

Ensure all documents are available during secondary assembly activities

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 amount assembled and the amount approved for distribution

eg. Work order, tracking records

Ensure batch record shall be verified and approved by qualified personnel

suggestion: include responsibility of verification of batch record in final release procedure

32

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

Record retention

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.

33

Materials control

For each delivery, incoming medical device are checked for integrity of package and seal, for correspondence between delivery note and the supplier's label, and for compliance with quality specification

perform incoming inspection, label verification, etc.

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.)

   

Appropriate procedures or measures are taken to assure identity of the contents of each packing of medical device

Create procedure/work instruction

Clearly identify bulk containers from which quantities of medical device that have been drawn

create proper labeling/identification/storage area

Placed medical device requiring special storage conditions in areas which are designed an equipped to provide desired conditions

eg. Medical device that needs temperature control

Continuously monitor and record storage and conditions

create storage and condition monitoring record

Express actual storage temperature quantitatively

record storage temperature in storage and condition monitoring record

the purchase, handling, and control of all packaging materials are accorded attention similar to that given to starting materials

ensure material control activities are according to procedure/work instruction

packaging materials are issued for use only by authorized personnel in accordance with documented procedure

include responsibility of issuing packaging material in procedure/work instruction

when setting up a program for packaging operations, particular attention is given to minimize risk if cross- contamination, mix-ups or substitutions

proper identification, segregation area

different medical devices shall not be packaged in close proximity unless there is physical segregation

create proper segregation area

34

Labelling

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.

perform labelling inspection/verification

35

Good assembly practices

Check medical devices and materials used for assembly before use by a designated person for quantity, identity and conformity with the packaging instructions.

perform inspection. Medical device and material used should be inspected by designated personnel only.

Performed line clearance prior commencement of assembly operation

suggestion: include line clearance activity in work instruction

Check and record the correct performance of any printing operation which is carrried out separately or in the course of packaging

perform label verification

Re-check printing by hand at regular intervals

Assembly equipment/apparatus are cleaned according to detailed and written procedures and stored only in

perform cleaning according to cleaning procedure

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.

calibration interval and checking of control environment should be specified in procedure or etc. records should be maintained

36

Quality control

Finished medical device assessment shall embrace all relevant factors,including assembly conditions, a review

create final release procedure, inspection criteria, etc. Perform inspection/verification according to specified requirement

of

packaging documentation, compliance with finished medical device specification and visual examination of

final finished pack

 

Process of secondary assembly shall not compromise conformity of medical device to essential principles of safety and performance

 

38

Medical device complaints

Establish documented procedure

Create complaint handling procedure

Review all complaints and other information concerning potentially defective and counterfeit medical devices, including description of action to be taken and reporting to relevant parties, where appropriate

To be included in complaint procedure and form (review section)

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

39

Distribution records

Document all activities relating to distribution

Maintain distribution records including receipts, storage, delivery and disposal

40

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

41

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, consultation with manufacturer and/or authorized representative should, where possible, take place before recall is instituted

consult Manufacturer and/or authorized representative if recall is instituted by other entity

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 between delivered and recovered quantities of products.

issue final report of recall process

42

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

43

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

Conduct internal audits at planned intervals

Internal audit plan should be created

Maintain records of audit and results

Records of audit shall be part of GDPMD system

Take action to eliminate detected nonconformities and causes without undue delay

Action should be taken immediately

44

Corrective action

Establish documented procedure

Create corrective action procedure and form.

45

Preventive action

Establish documented procedure

Create preventive action procedure and form. Suggestion: corrective action and preventive action procedure can be combined in one procedure