UPDATE: August 1st 2014

Provision no. Provision Requirements Recommendations/NotesGDPMD 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.

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

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 systemIdentify and control outsourced processes ie: sterilization, packaging... a close monitoring of these processes is also

required.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)..

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 procedureestablish and maintain records of GDPMD RCS establish an instruction for Good documentation practicesdefine 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 to be documented and communicated it is a good practice to have responsibilities and authorities documented in a

specific section for each procedureinterrelations between all personnel Organization chart (including handling personnel)

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 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.

results of internal and external audit

customer complaint/feedbackGDPMD regulatory compliance system and medical device compliancesurveillance and vigilancee activities including field safety corrective actions, advisory notes, recalls and adverse event/incident reportingfeedback from manufacturerfeedback and directives from the authoritystatus of preventive and corrective actionsfollow-up actions from previous management reviewchanges that could affect the GDPMD recommendatios for compliancecorrective and preventive actions required

effectiveness of GDPMD and its compliance with Malaysian medical device regulatory requirementsresource needsPersonnel 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.

Determine the necessary competences eg: during annual performance reviewsProvide training Suggestion: develop training needs based on performance review outcomeEvaluate training effectiveness Training evaluation form with effectiveness evaluation sectionMaintain training records, skills and experience Training records shall be part of the GDPMD systemEnsure premises ad equipment used are suitable, secure, safe and adequate Proper space for storage and handling of the productEstablish documented requirements Suggestion: Establish work instruction for maintaning the premises and

equipment, including their frequenciesMaintain records of maintenance activities Records shall be part of the GDPMD systemDetermine 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

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 systemSuggestion: 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 systemObtain 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

Manage and communicate with users, public and authority on medical devices dealing withEstablish and maintain efficient communication channel with manufacturers

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

Review Input11 management review shall include all of the review input

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GDPMD Regulatory Compliance System (RCS) -General

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Documentation6

Document control 7

Responsibilities and authorities8

Designated person9

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Personnel

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

Regulatory Compliance manual

Appoint designated person

Infrastrucure

Establish a pest control program

Scope and application

Organization

Work environment

Authorization

Training

Suggestion: create status report providing medical device feedback information to relevant party (Post-Market Surveillance)

Communication channel

Cleanliness and pest control

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.

Establish and implement inspection/other activities to ensure medical device meets specified requirements Suggestion: Perform incoming inspection, create incoming inspection logMaintain records of verification Inspection records shall be part of the GDPMD systemIdentify 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. WarehouseMaintain 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 handlingQuarantine status and quarantine area Provide proper identification and quarantine area/storage for nonconform

products Any system replacing physical quarantine should provide equivalent securityStorage 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 explosionIdentification 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) systemIdentification 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) 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 availableEnsure medical device should only be sold/distributed by designated persons or entities only suggestion: create list of approved distributor/customerProvide proper documentation to customers eg. : manuals, delivery notes with traceability information, etcKeep record of delivery transaction Records of delivery (eg. Delivery notes) shall be maintainedObtain 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 forwardersEnsure 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.

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

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

Maintain records

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).

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 systemMaintain updated records providing traceability of medical devices Maintain a list for customer/serial number of lot numberRecords 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 dateEstablish tracking records for all implantsIf 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 implantedSubmit surveillance reports to authority at least once a year submit yearly report to MDAEstablish documented procedure and work instructions for performing installation, testing and commissioning and maintenance activitiesEstablish 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 procedureEnsure proper installation, testing and commissioningEnsure equipment used for testing, maintenance and conservation of medical devices are calibrated or verified at specific intervalsEnsure calibration and maintenance of test equipments conforms to applicable standardsmaintain testing and commissioning, installation, calibration and maintenance service records. records should be part of GDPMD systemEnsure 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 GDPMDensure 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 agreementPhysically 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

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 usedImplementation 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 instructionEstablish 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

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.

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 areamedical device in storage area are appropriately labeled Identify properly (labelling, storage area, etc.)

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Storage and stock handling

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Materials control

Stock rotation

Delivery to customers

Control of nonconforming medical devices including returned medical devices

Disposal of medical devices

create implant tracking record/log to include all informations needed

Receipt of stock

Communication channel

Traceability

Specific traceability requirements for implantable medical devices

To be included in the procedure

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

Outsourced activities

Specific requirements for active medical devices

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

specify calibration or verification interval in work instruction

perfom installation qualification following the manufacturer protocol.

Assembly documents

Counterfeit adulterate, unwholesome and tampered medical devices

Secondary assembly including repackaging

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 areaPlaced 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 recordExpress actual storage temperature quantitatively record storage temperature in storage and condition monitoring recordthe 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 area34 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

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 instructionCheck and record the correct performance of any printing operation which is carrried out separately or in the course of packagingRe-check printing by hand at regular intervalsAssembly equipment/apparatus are cleaned according to detailed and written procedures and stored only in a clean and dry condition

perform cleaning according to cleaning procedure

Assembly equipment/apparatus do not present any hazard to the medical devicesParts of assembly equipment/apparatus that come into contact with medical devices do not effect quality of medical devices and present any hazardCalibrate 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

Finished medical device assessment shall embrace all relevant factors,including assembly conditions, a review of packaging documentation, compliance with finished medical device specification and visual examination of final finished pack

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

Process of secondary assembly shall not compromise conformity of medical device to essential principles of safety and performanceEstablish documented procedure Create complaint handling procedureReview 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 logMaintain records of complaints, investigation and action taken Create complaint formFollow-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 disposalEstablish documented procedure Create procedure for handling of FCA and FSNDefine responsibilities for planning, conducting and reporting of corrective actions in procedure Include responsibilities in procedureEstablish writing a recall/withdrawal procedure in consultation with manufacturer Establish recall procedureInform 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 immediatelyInform overseas counterparts on FCA and FSN if medical devices are exported Communicate with overseas counterpart if medical devices are exportedMaintain records of action taken and approval by manufacturer and authority Records shall be maintainedEstablish documented procedure Recommendation: Recall can be included in FCA procedureEnsure the system comply with regulatory requirementsManufacturer and/or authorized representative shall be informed in the event of recall Inform Manufacturer and/or authorized representativewhere 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

Establish documented procedure Establish mandatory problem reporting procedureEach incident report shall lead to a final report where corrective actions are applicable create mandatory problem report formEstablish 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 planDefine 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 createdMaintain records of audit and results Records of audit shall be part of GDPMD systemTake 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

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Materials control

Quality control

Medical device complaints

FCA and FSN

Mandatory problem reporting

Internal audits

Recall

Good assembly practices

perform label verification