ACCEPTANCE ,TESTING AND

VALIDATION PROCEDURE

CHAPTER 2
SCOPE

This Malaysian Standard applies to medical devices placed for use in any healthcare facility or any
other facility or residential which requires installation, testing and commissioning (T&C) and
acceptance of medical devices excluding implantable medical devices. This standard is intended to;
a) Provide guidance to comply with the requirements under Section 43 - Usage, operation, maintenance, etc.,
of medical device in the Medical Device Act 2012 [Act 737];

b) Provide guidance on the procedures for installation, T&C, and acceptance of medical devices in
healthcare facility, aesthetic settings, and premises for wellness programs and related services; and

c) Ensure the medical device is appropriately installed, tested and commissioned by the equipment specialists
or competent personnel and accepted in accordance with manufacturer’s specification, purchase agreement
and statutory requirement.

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OBJECTIVES / LEARNING OUTCOME

• Describe the components in acceptance , testing and validation

procedure (C2)
• Analyse the categories in the calibration of medical device (C4)
• Explain the process during acceptance , testing and validation
procedure (C4)

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 This procedure is
necessary to ensure all
staff involved in the
purchase, loan or trial of
ACCEPTANCE: medical devices follow
When equipment has been the correct process for the
purchased, loaned or trialed, it acceptance of medical
must undergo acceptance devices
testing
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 Medical device testing is the
TESTING: process of demonstrating that
In new product development, the device will reliably and
extensive Design Validation Testing safely perform in use.
is applied. This includes performance
testing, toxicity and chemical
analysis, and sometimes human
factors or even clinical testing.
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 The target of
the validation is to make
sure the user needs are
VALIDATION: met in a medical device
Validation is the process of making that consistently
sure that you have objective provides the intended
evidence that user needs and medical benefit in actual-
intended uses are met. It is usually use conditions.
done by tests, inspections, and in
some cases analysis
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2.2 PROCEDURE
2.2 PROCEDURE
Testing and acceptance of medical devices
• For a newly purchased medical device,
the medical device establishment shall
be responsible to carry out the installation
and T&C of the medical device while the
medical device owner shall be
responsible for the acceptance processes
of the medical device as detailed in this
document (refer Figure 1).

• Medical devices which are leased, on-

loan, for trial evaluation, clinical
research/investigation, transferred and
undergone major upgrading, shall be
installed, tested and commissioned before
initial use.

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2.2.1 PRE-REQUISITE
2.2.1 PRE-REQUISITE
Definition

• a thing that is required as a prior condition for something else to happen or exist or something
that is necessary to an end or to the carrying out of a function.
Synonym : REQUIREMENT
• Type of condition during pre-requisite:
1) Purchase of a NEW MEDICAL DEVICE
2) OTHER THAN NEWLY PURCHASED MEDICAL DEVICES

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 2.2.1 PRE-REQUISITE
Documentation
For the purchase of a NEW MEDICAL DEVICE, documentation as listed (but not limited to) below shall be made available to medical
device owner by medical device establishment prior to T&C:

1. device registration certificate and Establishment License from Medical Device Authority (MDA);

2. purchase agreement; or tender document; or contract document; or quotation;

3. purchase order, T&C date by the medical device establishment;

4. relevant licenses and certificates:

i. factory test certificate;
ii. software license (as provided by the manufacturer of the medical device);
5. List of equipment specialist responsible to carry out the T&C;

6. manuals (user, operation, service, spare part list, list of tool and test equipment required, circuit diagram, planned preventive
maintenance manual and checklist as per manufacturer’s requirement);

7. all approval document from regulatory body (where relevant); and

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8. as build drawing of site and facility where relevant.
2.2.1 PRE-REQUISITE
Documentation
For OTHER THAN NEWLY PURCHASED MEDICAL DEVICES such as leased, on-loan, for trial evaluation,
clinical investigation, transferred from one location to another location (that requires installation), donated
and medical device undergone major upgrading or refurbished, documentation shall include (but not limited
to):
1. device registration certificate and establishment license (if applicable) from MDA;
2. purchase agreement/ leased agreement/tender document/quotation (where applicable);
3. purchase order, T&C date by the medical device establishment (where applicable);
4. relevant licenses and certificates:
i. factory test certificate or equivalent certificate;
ii. software license (applicable only for software related medical device); and
iii. installation qualification, if applicable;

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2.2.1 PRE-REQUISITE
Documentation
5. list of equipment specialist and/or competent personnel responsible to carry out the T&C;
6. manuals (user, operation, service, spare part list, list of tools and test equipment required, circuit
diagram, PPM Manual and checklist as per manufacturer requirement);
7. all approval document from regulatory body (where relevant);
8. as build drawing of site and facility where relevant;
9. maintenance history (include quality assurance test details where relevant);
10. a clear statement that the equipment is being resold/donated; and
11. proof of decontamination.

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2.2.1 PRE-REQUISITE
Documentation
• Medical device establishment (Vendor/Supplier) shall provide written notification of any specific
installation and T&C requirements.

• For NON-ACTIVE MEDICAL DEVICE, only inspection, training and acceptance procedure is required. (to
change all non-active device to non-active medical device)

• For management of radioactive source; medical device owner shall refer to medical device establishment
and regulatory authority.

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2.2.2 MEDICAL DEVICES CATEGORY
2.2.2 MEDICAL DEVICES CATEGORY
Medical devices are categorised into active medical device and non-active medical devices.

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2.2.3 REQUIREMENT FOR INSTALLATION

Active medical device/system has two type of condition which are:

1. REQUIRES INSTALLATION
2. NOT REQUIRE INSTALLATION

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2.2.3 INSTALLATION REQUIREMENT &
PROCEDURE
2.2.3 REQUIREMENT FOR INSTALLATION
For active medical device that REQUIRES INSTALLATION
Active medical device/system installation usually applies when any of the
following occurs:

a) substantial assembly work will be required on-site;

b) there are dedicated plumbing, electrical and gas pipeline connection for
the equipment; or
c) the device needs to be permanently fixed in place.

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2.2.3 REQUIREMENT FOR INSTALLATION
For active medical device that REQUIRES INSTALLATION
Pre-requirement before installation procedures are:

a) Healthcare facilities shall ensure site preparation is in accordance to

manufacture and regulatory requirement
b) Medical device installation layout shall endorse by professional,
competent technical personnel
c) Vendor shall install in accordance to manufacture’s technical specification
for installation work.

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2.2.3 REQUIREMENT FOR INSTALLATION
For active medical device that REQUIRES INSTALLATION

Requirements
• The medical device owner with medical device establishment input or advice shall ensure site
preparation is in accordance to establishment and regulatory requirement.
• The medical device owner shall ensure that all technical documentation such as drawing shall
be officially endorsed (medical device layout, mechanical and electrical (M&E), civil and
structural) is submitted to the relevant authorities / departments for approval prior to installation.
• Medical device installation layout shall be endorsed by professional competent technical
personnel.
• Medical device establishment shall install the medical device in accordance to manufacturer’s
technical specification for installation work.
• All as built drawings shall be made available and submitted to competent technical personnel
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of medical device owner.
2.2.3 REQUIREMENT FOR INSTALLATION
For active medical device which DOES NOT require installation;

a) The medical device owner, with medical device establishment input or advice shall
perform pre-check prior to T&C. The pre-check includes:

i. availability and sufficient utility i.e.: medical gas, electrical supply

(essential/non-essential), water supply;

ii. appropriate placement area i.e.; ventilation, humidity, room temperature.

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2.2.3 INSTALLATION PROCEDURE
2.2.3 REQUIREMENT FOR INSTALLATION
For active medical device which DOES NOT require installation;
Pre-requirement procedures:

a) Perform pre-check prior to T&C

b) Pre-check includes availability and sufficient utility such as medical gas,
electrical equipment, water supply or humidity.

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5 KEYS TO PROPER SETUP FOR MEDICAL DEVICES

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2.2.4 INSTALLATION PROCEDURE
✓ While a competent, capable, and expert team of staff members is the backbone of any hospital or healthcare
facility, having up-to-date and functional equipment can make it easier to provide extraordinary patient care.

✓ Technologically advanced equipment not only improves patient satisfaction, but also increases staff efficiency - both
of which lead to more revenue

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2.2.4 SITE PREPARATION
2.2.4 SITE PREPARATION
Renovation

Medical device owner shall furnish the details of the renovation scope of work and a
room data sheet recommended by medical device establishment. A room data sheet
provides information on the minimum requirements for the room where the medical device
is to be installed. The information shall include room details, room fabric, fittings and
furniture, fixtures and equipment with associated services.

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2.2.4 SITE PREPARATION
Renovation
d) utilities details to support the installation of medical device and corresponding associated drawing.
Refer Table 2.

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2.2.4 SITE PREPARATION
Renovation
Medical device owner shall prepare documentation (plan and side elevations view) that includes:

a) architectural drawings giving details of the renovation works as stipulated in the scope of work.
Details of any partitions or panels required should include furniture, type of floor finishes, wall finishes and
ceiling finishes as recommended by the manufacturer, local statutory and regulatory requirement;

b) structure drawing shall be endorsed by the professional engineer if required;

c) layout and positioning details of the medical device and related systems as recommended by the
manufacturer and local statutory and regulatory requirement;

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2.2.4 SITE PREPARATION
X-ray Machine Room Layout

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2.2.4 SITE PREPARATION
X-ray Machine Room Layout

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2.2.4 SITE PREPARATION
MRI Machine Room Layout

Zone IV

Zone III

Zone II

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Zone I
2.2.4 SITE PREPARATION
Renovation
• Medical device owner shall provide a matrix of responsibilities (for example, please see Annex A)
clearly stating the parties or person responsible to prepare or provide a particular scope of work or
utilities required for proper installation of the medical device.
• Prior to installation, all drawings related to installation of the medical device shall be verified by
professional competent technical personnel (e.g. competent technical personnel, medical physicist –
depending on the type of medical device) and agreed by user.
• Medical device owner shall ensure renovation and site preparation works are carried out according to
the approved scope of work and shop drawings.
• The renovation and site preparation works shall be supervised by competent technical personnel.

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2.2.4 SITE PREPARATION
Renovation
NEW BUILDING / NEW BUILDING EXTENSION
• Medical device owner shall appoint a team of consultants consisting of architects, civil and structural
engineers, mechanical and electrical engineers, quantity surveyor and medical device planner. The
consultants shall be registered with their respective professional boards or other relevant bodies.

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2.2.4 SITE PREPARATION
Renovation
MOBILE HEALTHCARE FACILITIES

• Services provided on fixed routes and at a number of points, which are visited on a regular basis. Some
visiting points may involve the use of a room in a building, but the resources (equipment, stocks) are
provided from the mobile when the service is available and are not maintained at the visiting point.
• Medical device owner shall submit a technical report on the suitability of the proposed vehicle from
Road Transport Department and other relevant authorities;

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2.2.4 SITE PREPARATION
Renovation
Medical device owner shall prepare relevant document that includes:
• a) drawings giving details of the retrofitting works required to make the mobile facilities functional for its
purpose. Details of any partitions or panels required should include the type of floor finishes, wall
finishes and ceiling finishes as recommended by the establishment or manufacturer and the relevant
authority;
• b) layout and positioning details of the medical device and related systems;
• c) safety features or harness required as recommended by the medical device establishment or
manufacturer and the relevant authority; and
• d) utilities details such as cold water supply, treated water supply, electrical supply, steam supply,
medical gases and drain. Refer Table 2.

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2.2.4 SITE PREPARATION
Renovation

• All drawings shall be approved by user and authorised persons (e.g. competent technical personnel,
medical physicist and relevant authority– depending on the type of medical device).
• The mobile medical device owner shall carry out the vehicle renovation and site preparation works
according to the approved scope of work and drawings.
• The mobile medical device owner renovation and site preparation works shall be supervised by the
appointed consultants and competent technical personnel.

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2.2.5 MEDICAL DEVICE INSTALLATION
2.2.6 CALIBRATION
2.2.5 MEDICAL DEVICE INSTALLATION
• Site preparation works for the installation of medical device shall be ready prior to installation.

• Appointed competent technical personnel by medical device owner shall:

a) verify all relevant documents prior to device installation;
b) ensure the facility is ready prior to installation as required by the manufacturer and relevant statutory
requirement, e.g., for MRI the load consideration, RF shielding requirement and power supply requirement;
c) ensure that the installation complies with manufacturer’s instruction, approved technical drawings and
statutory requirements; and
d) ensure that the installation complies with all safety requirements as required by manufacturer and relevant
authority.

• Medical device establishment shall ensure only equipment specialist(s) will carry out the installation.

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DEFINITION

• Medical Device Equipment Calibration is a procedure for detecting and fixing the uncertainties
in measurements and bringing them to an acceptable level. The accuracy of the device has a
great deal of importance, as it can seriously affect the diagnostic procedure and endanger
patients' life
• Calibration also known as a comparison of two measurement devices or systems, one of
known uncertainty (standard) and one of unknown uncertainty (your test equipment or instrument).
• All test equipment that make a quantitative measurement require calibration from time to time.
• ☺ E.g. :gas pump, weighting scales, electrical instrument etc
• ☺ Standard involved in calibration is ISO 17025

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 CALIBRATION CATEGORIES
1) Active medical device functionality calibration
• Performed by the technical staff in accordance to manufacturer specifications as part of PPM
activities (Quantitative Task)
• No certificate is required but must be recorded in the report.
• Can be classified into
a) built-in self-calibration, designed as part of active medical device feature; and
b) manual calibration using appropriate calibration equipment, tools or test equipment.
2) Calibration of measuring or test equipment
• carried out by approved or authorised calibration centre conforming to nationally /
internationally recognised accreditation body.
3) Certified calibration
• Healthcare facility shall identify and calibrate medical devices requiring calibration by
external accredited laboratories based on regulatory and accreditation requirements.
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46

PURPOSE OF CALIBRATION
• To ensure readings from an instrument are
1. consistent with other measurements.

• To determine the accuracy of the instrument

2. readings.

• To establish the reliability of the instrument i.e.

3. that it can be trusted

• to eliminate or reduce bias in an instrument's

4. readings over a range for all continuous values
47

ASPECT OF CALIBRATION
Quality
System

Traceability ISO 17025

Method Management
Validation Requirement

Technical
Requirement
48

METHOD VALIDATION
☺ Method validation is the process used to confirm that the analytical procedure employed for
a specific test is suitable for its intended use.

☺ To determine of the performance of method should be as following :

i. Calibration using reference standard or reference materials

ii. Comparison of result achieved with other method

iii. Interlab comparison

iv. Systematic assessment of the factors influencing the result

v. Assessment of the uncertainty

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TRACEABILITY
☺ Traceability is the property of a measurement or the value of a standard whereby it can be

related to stated references, usually national or international standards, through a valid chain of

calibrations all having stated uncertainties.

☺ Calibration or testing laboratories shall establish traceability of its own measurement standard and

instrument to SI units.

☺ Measuring and test equipment used in testing must comply similarly with Calibration labs

requirement.

☺ If traceability to SI units is not relevant, other methods of traceability is acceptable.

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CALIBRATION CHAIN

INTERNATIONAL STANDARD

National Metrology Institute

user

Calibration Calibration
Laboratories Calibration
Center

Calibration
Calibration Department

Calibration
In-house Measuring Instrument

measurement
Products Manufactured
2.2.6 CALIBRATION
• The medical device establishment shall produce the manufacturer’s calibration
certificate or report for any medical device that does not require on- site
calibration.
• The medical device establishment shall perform the calibration as per
manufacturer’s specification for any medical device that requires on-site
calibration.
• Any medical device that requires certified calibration shall be carried out by a
recognized and accredited calibration laboratory; and medical device
establishment shall ensure the calibration is performed as per the manufacturer’s
specification.
• Medical device establishment shall submit calibration test report and calibration
certificate of the medical device to the medical device owner.
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2.2.6 CALIBRATION
• The calibration certificate of all test equipment used shall also be submitted to
the medical device owner.

• The calibration test report shall be verified and endorsed by competent

technical personnel.

• The medical device establishment shall rectify all faults that causes calibration to
fail and re-perform the calibration until it passes.

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FUNCTIONAL
CALIBRATION
REPORT/RESULT

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 CALIBRATION CERTIFICATE
Customer details

Device under Test (DUT) details

Environmental condition

Date calibration & due date

Calibrated reference devices information and traceability

Calibration Laboratory information

Calibrator and Approved Signatory

Accredited Logo and ISO 17025

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CALIBRATION CERTIFICATE
Validated Calibration procedure

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CALIBRATION CERTIFICATE
Report information details

Parameter calibration

Set value

Measured value before adjustment

Measured value after adjustment (if applicable)

Upper & Lower Limit

Result (Pass/Fail)

Expended uncertainty
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CALIBRATION CERTIFICATE
Report information details

Decision Rules

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58
2.2.7 TESTING AND COMMISSIONING
DEFINITION

• Testing and Commissioning is a quality-oriented process for achieving, verifying, and

documenting that the performance of facilities, systems, and assemblies meets defined

objectives and criteria. It is an all-inclusive process consisting Planning. Coordinating. Delivery.

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 KEY ELEMENT ON T&C AND ACCEPTANCE PROCEDURE
Notification to parties that Validate test result based
involve in acceptance test Conduct test on Acceptance Check List
(user,BMET)

Give assest number, record If regulatory criteria for

into asset database and acceptance test have been
formally handed over to satisfied, accept the device,
user if not, need modifiaction
Example Assest Tag and re-do the test
2.2.7 TESTING AND COMMISSIONING
• The medical device owner shall verify that the medical device delivered is in good condition and
complete based on the purchase document.
• Physical evaluation / visual checks of the medical equipment include observations of:
a) chassis - verify physical integrity, cleanliness and condition;
b) mount / fasteners - verify physical integrity;
c) castor / brakes - verify proper function and integrity;
d) power cord / strain relief - verify that power cord is of medical grade and comes with strain relief;
e) fittings / connectors - check all external fittings/ connectors;
f) control / switches - verify proper operation of controls;
g) indicators / displays - verify for good condition;
* For an example of testing and commissioning
h) accessories - verify physical integrity; and checklist, please see Annex B.
i) labelling - verify correctness.

• T&C is best performed at the very location of which the medical equipment will be placed for use.
• Medical device establishment shall operate the medical device to ensure it is functional and ready to
62 be tested.
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2.2.7 TESTING AND COMMISSIONING
• The competent technical personnel of the medical device owner shall ensure that all required documents
and the following is made available during T&C by the medical device establishment:
a) copy of delivery note / delivery order and ensure that;
i. physical delivery must tally with delivery note;
ii. to specify separately between main system, subsystems, accessories and consumables;

b) certificate of acceptance;
c) declaration of CE or IEC conformance and a copy of calibration certificate;
d) backup copy of software for user and software license inclusive of access code/key/password;
e) declaration of previous recalls / device alerts / end of life date;
f) quality assurance result and certificate;
g) service engineer training certificate (by manufacturer or manufacturer appointed trainer);
h) response time during warranty period - on call and on site;
i) tentative date and syllabus for user training;
j) tentative date and syllabus for technical training;
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2.2.7 TESTING AND COMMISSIONING
The medical device establishment is required to perform specific tasks during T&C on the medical device
and the task includes:
a) confirmation of items delivered based on purchase document;
b) validation of the specification/parameters using appropriate test equipment;
c) all other relevant safety test to the equipment shall also be conducted and recorded accordingly.

• The equipment specialist from medical device establishment shall carry out performance and safety tests as
required by the manufacturer, witnessed by competent technical personnel.
• A label indicating the medical device passed the electrical safety test shall be affixed at a visible area on the
device (for example, please see Annex C).
• All results shall be documented, medical device establishment shall keep all documents according to retention
period specified by MDA and a copy is submitted to medical device owner.
• The competent technical personnel shall verify the performance and safety test carried out by equipment
specialist from medical device establishment.
• T&C shall be repeated upon rectification of all deficiencies by medical device establishment.
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66
2.2.8 INSPECTION OF NON-ACTIVE MEDICAL
DEVICE
2.2.8 INSPECTION OF NON-ACTIVE MEDICAL DEVICE

• Non-active medical devices does not involve in installation process

• For active medical device that requires installation:
• Healthcare facilities shall ensure site preparation is in accordance to manufacture and
regulatory requirement
• Medical device installation layout shall endorse by professional, competent technical personnel
• Vendor shall install in acccordance to manufacture’s technical speciifcation forn installation
work.
• For active medical device which does not require installation:
• Perform pre-check prior to T&C
• Pre-check includes availability and sufficient utility such as medical gas, electrical equipment,
water supply or humidity.

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2.2.8 INSPECTION OF NON-ACTIVE MEDICAL DEVICE
• Medical device owner accepting the device has the discretion to determine when and where the device
should be inspected and sampled for conformance to specifications depending upon the risk that failure
of that device may pose.
• Non-active Medical device shall be inspected by:
a) medical device establishment ;
b) medical device owner – material / procurement warehouse; and
c) medical device owner - user.

• Medical device owner shall perform general acceptance inspection on random sampling basis for
non-active medical device against the purchase order.

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2.2.8 INSPECTION OF NON-ACTIVE MEDICAL DEVICE
• Inspection tasks shall include but do not limited to:

a) checking and verifying the product is exactly as ordered and corresponds with the delivery note;
b) verification of quantity, size, consumable items and accessories delivered as stated in the purchase agreement;
c) visual inspection of the device or equipment for physical damage, incompleteness, misassemble, void, wear and
/ or abuse;
d) check relevant labelling on the device;
e) take note on batch number or lots in the event of a product recall;
f) contamination;
g) disseminate instructions and safety information when necessary.

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2.2.8 INSPECTION OF NON-ACTIVE MEDICAL DEVICE
• Rejected medical devices shall be documented, rectified or replaced by the medical device
establishment.
• Medical device establishment shall provide proof of compliance to the specification in purchase
document.
• Records of inspection shall be kept by medical device owner.

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ISSUANCE OF T&C CERTIFICATE
• T&C certificate (for example, please see Annex D) shall be issued by medical device
establishment once T&C process is successfully completed. The certificate shall be
signed by:

a) medical device establishment;

b) medical device owner; and
c) competent technical personnel.

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ISSUANCE OF T&C CERTIFICATE
74
2.2.9 EQUIPMENT TRAINING
2.2.9 EQUIPMENT TRAINING
On-site Equipment training
a) Medical device establishment shall provide user and technical on-site hands-on equipment training before use.

b) The equipment training module shall include but not limited to:

i. safety precautions in operating the medical device;

ii. proper operation / application including features unique to the particular manufacturer or model of medical device;
iii. user maintenance;

iv. cleanliness and decontamination;

v. operational verification procedures;
vi. recognition and correction of common operational problems;

vii. recognition of defective equipment and potential hazards;

viii. the risk associated with the device.

c) Certificate of attendance shall be issued by medical device establishment to the user upon completion of the training. (fo r example,
please see Annex E).
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77
2.2.9 TECHNICAL TRAINING
2.2.9 TECHNICAL TRAINING

Medical device establishment shall offer competence clinical and/or technical training to the appropriate
personnel upon request or stated in the purchasing agreement. The competence training module shall be in
accordance with manufacturer and includes the above mentioned equipment training module and other
module not limited to:

i. clinical competence modules

ii. maintenance competency level.

b) Certificate of competency shall be issued by medical device establishment to the competent personnel
upon completion of the training.

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2.2.10 ACCEPTANCE
2.2.10 ACCEPTANCE
Non active medical device

a) Non-active medical device is accepted upon completion of successful inspection and training.

b) The records of acceptance shall be signed by medical device establishment and medical device owner (for
example, please see Annex F).

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82
2.2.10 ACCEPTANCE
Active medical device
a) The Competent technical personnel shall perform the tasks that includes, but not limited to:
i. ensuring the medical device is exactly as ordered and corresponds with the delivery note;
ii. verifying of quantity, consumable item and accessories delivered as stated in the purchase agreement;
iii. ensuring the equipment has successfully undergone performance and safety tests;
iv. checking of relevant labelling on the device;
v. ensuring the medical device is delivered with a full set of documentation including user and operating
manuals, spare part list, schematic diagram, PPM manual and checklist as recommended by manufacturer,
validated T&C report and certificate, calibration certificate, training certificate and any other relevant
documents. The documents delivered shall be in Bahasa Malaysia;
vi. ensuring the medical device technical support information from medical device establishment is submitted
(address, person in-charge, telephone number, fax number, medical device registration number and any
relevant information);
vii. ensuring the user and technical training on the medical device has been carried out.

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2.2.10 ACCEPTANCE

b) Upon passing acceptance testing, the medical device shall be labelled indicating:

i. asset identification; (Refer Figure 2).

ii. warranty information; (Refer Figure 3)
iii. performance test pass label;
iv. electrical safety pass label (where applicable; Refer Figure 4); and
v. next PPM due date.

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2.2.10 ACCEPTANCE

c) Acceptance certificate (Annex G) shall be issued by medical device establishment once acceptance
process is successfully completed. The certificate shall be signed by:

i. medical device establishment;

ii. medical device owner; and
iii. competent technical personnel.

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86
2.2.10 ACCEPTANCE

d) Warranty period and PPM frequency (within the warranty period) shall be specified in the acceptance
certificate.

e) Software license inclusive of access code/key/password shall be handover to the user.

f) Medical device establishment shall ensure all spare are available for purchase by medical device owner
or any authorised maintenance providers.

g) The medical device establishment shall ensure 10 years spare parts availability from the date of last
production of the medical equipment.

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“QUOTE”