How to comply with Malaysia Medical Device Regulations 2012? Mourad Kholti 5th March 2014 The 17th SE-Asian Healthcare Show, KLCC, Kuala Lumpur презентация

SE-Asian Healthcare Show,
KLCC, Kuala Lumpur

specializing in Medical Devices Regulatory Affairs
and Quality Management.


Expertise:
Product registrations & licensing in ASEAN region
Regulatory Strategies in ASEAN and Europe
Quality Management Systems:
(ISO 13485, US FDA 21 CFR part 820, GDPMD)
Clinical Evaluation
Suppliers Auditing
Local Authorized Representation
Certification audit in partnership with a European Notified Body

of Health Malaysia (MOH) in charge of regulating medical device and its industry players in Malaysia. 

Objectives:
to protect the public health and safety and,
to ensure that new technology is made available for use for patients in a timely manner and at the same time facilitating trades and the medical device industry.  

How?
through a comprehensive regulatory control and licensing system of:
medical device products
manufacturers, LAR, importers, and distributors. 

machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease
diagnosis, monitoring, treatment, alleviation of or compensation for an injury
investigation, replacement or modification, or support of the anatomy or of a physiological process
support or sustaining life
control of conception
disinfection of medical device, or
providing information for medical or diagnostic purpose by means of in-vitro examination of specimens derived from the human body,
which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means; and

reagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk declare to be a medical device by order published in the Gazette.

of weak or injured knees. With comfortable, breathable, soft, smell-free, materials, it is recommended for knee joint distortions and effusions, after surgical interventions, scars treatments, oedemas, sprains and contusions.

Medical device definition:
…diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

Is my product a Medical Device ?

manufacturer, importer, or distributor who is responsible for placing any medical device in the market but does not include a retailer and

B) an authorized representative* appointed by a manufacturer having a principal place of business outside Malaysia.
* person domiciled or resident in Malaysia/a firm or company constituted under the laws of Malaysia

sales & marketing or on Regulatory Affairs?
Do I have to scrap all my labels, inserts and packaging, if I want to change distributors ?
In case of incident due to transportation from the distributor to the end-user, will my distributor defend his company or mine?
If my distributor is unable to answer MDA’s questions, does anyone in my company have the skills to do so directly?
Will confidentiality be maintained when sharing a CSDT containing technical information with my distributor?
Will my distributor stay up to date on regulatory changes in Malaysia and will provide me with timely warning when changes affect my devices?

Registration of Medical Device
Part IV: Registration of Conformity Assessment Body
Part V: Establishment License
Part VI: Export permit
Part VII: Labelling Requirements
Part VIII: Appeal
Part IX: Register

definition for labelling, licensee, registration holder, conformity assessment.

and grouped
All medical devices shall be subjected to conformity assessment
Depending on the class, the manufacturer shall appoint a CAB to conduct the assessment
If the conformity assessment is successful, CAB will issue:
Report
Certificate of Conformity

Device shall be made to MDA using the web-based online system
The application shall be accompanied with:
Application fee
Supporting documents
Any other information required by MDA
Samples of medical device (if required)
If MDA is satisfied, the MD will be kept in the register for a period of 5 years
Cancellation of registration

a CAB shall comply with the requirements specified in 4th schedule.
The CAB application shall be accompanied with:
Application fee
Supporting documents
Any other information required by MDA

If MDA is satisfied, the CAB will be registered for a period of
3 years

made to MDA using MEDCAST.
The application shall be accompanied with:
Application fee
Supporting documents
Certificate and report of conformity assessment
Any other information required by MDA
If MDA is satisfied, the establishment license will be issued for a period of 3 years
Suspension or revocation of establishment license

labelled according to 6th schedule

Shall be legible, permanent, and prominent

No statement saying that the placement in the market is promoted or endorsed by MDA (fine RM10K and/or 3 months imprisonment)

schedule: Conformity Assessment procedure
Fourth schedule: Requirements for the registration of CAB
Fifth schedule: Table of fees
Sixth schedule: Requirements for labelling

device intended for diagnosis
Hazard
Risk
etc…

classifying its medical device

(tables):
Appendix 1 to classify Medical Devices excluding IVD
Appendix 2 to classify IVD devices

Example: all surgically invasive MD intended for short-term use are in class B (rule 7)

If more than one rule is applicable, the higher classification shall apply.

of the following categories:
single
family
system
set
in-vitro kit
in-vitro cluster

The basic rules of grouping consist of:
one generic proprietary name
one manufacturer
one common intended purpose

Manufacturer.
If the manufacturer is not in Malaysia, it shall:
authorize a LAr to act on its behalf
provide all the evidence of conformity
provide necessary support to the LAr for the purpose of the assessment
Depending on the class, a CAB shall be appointed to conduct the assessment.

the QMS
conformity assessment of PMS
conformity assessment of Technical documentation (CSDT)
DoC
Once assessment completed

and Performance of Medical Device (checklist)
Appendix 2: Common Submission Dossier Template
Appendix 3: Declaration of Conformity
Appendix 4: Requirements on QMS

requirements for a person who wish to be registered as a Conformity Assessment Body:
requirements on organization
requirements on resources and technical competency
requirements on independence and impartiality
requirements on Quality Management System

if symbols are used, provide explanation
Language: Bahasa Melayu for home-used devices (also for others if required by MDA)
Contents: manufacturer AND LAr names, lot nbr, serial nbr, expiry date…
IFU: precautions and warnings, etc…

30th 2014)

Manufacturer (ISO13485)
Authorized rep (GDPMD)
Importer (GDPMD)
Distributor (GDPMD)

Conformity assessment
(before June 30th 2015)

Manufacturer QMS
Manufacturer PMS
Summary Technical Documentation
Declaration of Conformity

MedCast registration

MedCast registration

MDA approval