TUNKU PUTERI INTAN SAFINAZ SCHOOL OF ACCOUNTANCY

COLLEGE OF BUSINESS
UNIVERSITI UTARA MALAYSIA

BKAL3023 PUBLIC SECTOR ACCOUNTING

SECOND SEMESTER 2021/2022 A212

Individual Assignment

Group H

NAME : SHANTENE A/P SUBRAMANIAM

MATRIC NO. : 272881

ORGANIZATION : Medical Device Authority (MDA)

Company Background
The Malaysian medical device industry is served by Medical Device Authority MDA, a
government employer. The Medical Device Act of 2012 is being implemented by a
federal statutory employer that reports to the Ministry of Health Malaysia (Act 737). The
primary goals of the Act are to address issues with public health and safety related to
medical devices as well as to promote trade and business in clinical devices. The
Cabinet approved the improvement and execution of the clinical tool regulatory
application in February 2005. Medical Device Authority Act 2012 (Act 738) and Medical
Device Act (Act 737) were published in the Gazette on February 9th, 2012, after the
Cabinet's selection. MDA was set up in accordance with Act 738 on March 15, 2012 and
has been publicly and fully operational since June 16, 2012.

Board of Directors
In the case of public businesses, a board of directors is chosen by shareholders to
determine strategy and exercise control over a company. As you can see, the board of
directors meeting had been conducted four times in both years 2019 and 2020, but only
twice in year 2018. The board of directors remained the same for years 2018, 2019, and
2020, with the exception of Dato' Mohd Shafiq Abdullah, who is the Ministry of Health's
representative, and Ahmad Farhan B. Mohd Yunus, the MDA's secretary.

Audit Committee
One of the main operating committees of a corporation's board of directors is the audit
committee, which is in charge of monitoring financial reporting and transparency. There
are no meetings stated in the annual report for the audit committees throughout the
three years. As with the CAB audit, product and premises of quality management audit,
and the post-order regulatory audit, their functions and tasks are nearly similar. The
audit committee's primary duties include monitoring inspections of CABs and
institutions, observing audits of registered auditors, and inspecting the status quo's
satisfactory control system (ISO 13485).

Other Committee
No compensation, procurement, or nomination committee have been mentioned in the
annual report. The individual on the other committees, Pn. Aidahwaty Ariffin and En. M.
Olaybal, have maintained an equal salary for more than three years running. In the
organizational structure of MDA, the Integrity Unit is located beneath the Office of Chief
Government Office. There are some other committees which are unit head of respective
departments such as registration and licensing, surveillance and enforcement and
industry policy and assistance.
Ethics and Values
Additionally, the code of ethics and the fundamental fee often remain the same over the
years. For instance, the code of ethics states that MDA employees must always pledge
allegiance to the Yang di-Pertuan Agong, the United States, the Government, and MDA.
They must also constantly uphold MDA's reputation as a premier organization and
follow all rules, regulations, and directives that are in effect at the time they begin
working there. As for fundamental moral principles, it is integrity,effective, and
professional.

Integrity
Running your company consistently in accordance with a strong set of ethical ideals and
while adhering to pertinent ethical guidelines is part of having integrity in your strategy.
Next is the integrity unit, whose interests for year 2020 include briefings at the
development of the MACC Joint Organizational Anti-Corruption Plan, Anti-Corruption
Plan Development Workshop, and Corruption Risk Management Plan. These interests
are included in Treasury Instruction 309(AP. 309). As we are all aware, the integrity
unit's responsibilities include overseeing MDA's management, finances, procurement,
and human resources as well as detecting, validating, and managing complaints of
fraud; and managing disciplinary and moral misconduct cases and also taking
appropriate action. In year 2019, the integrity unit is responsible for ensuring effective
governance and integrity as well as reviewing and validating legal documents.

Internal control
Internal control, as stated by accounting and auditing, is a method for ensuring that an
organization's goals in operational effectiveness and efficiency, reliable financial
reporting, and compliance with laws, rules, and policies are met. There is not a distinct
section for this internal manipulation in this aspect. They are responsible for monitoring
compliance with all imposed legal requirements by the parties involved in this
manipulate framework, acting as MDA's internal audit unit in the process. En. Yusof bin
Mohd Johari and En. Idamazura Idris@ Harun had been the head of internal control for
more than three years. There have been 33 enforcement warning letters issued, which
is a low number compared to year 2019's 60 issued warning letters. They also do raids,
seizures, and analyses of intelligence and grievance verification. It has been reported
that they received and handled 98 cases for non-compliance in total as for year 2019,
whereby in year 2020, 114 lawsuits were filed.

Risk Management
The process of identifying, evaluating, and controlling risks to a company's assets and
revenue is known as risk management and control. En. Aidahwaty Ariffin @M.Olaybal
will serve as the MDA's chief risk officer in year 2018 until 2020. MDA conducted more
activities in year 2019 to reduce risk, including handling 74 marketing-related complaints
about medical devices and products that make claims to be medical devices, which is
the same number as in 2018, delaying 60 warning letters for various Act 737 violations,
managing 98 non-compliance court cases, and conducting 3 raids. As you can observe
in year 2020, MDA only engaged in one activity, which was the MOH-organized Anti-
Corruption Plan Development Workshop & Corruption Risk Management Plan.
However, there might not be a separate section on risk having stated in annual report.

Stakeholders
A stakeholder is a group that has an interest in a company and who may either
influence or be harmed by the business. A normal organization's traders, workers,
clients, and providers are its top stakeholders. MDA constantly rewards and
compensates their staff in order to compete. Due to the beneficiaries of the exemplary
service award, a total of five MDA employees in each division were chosen in year
2018. Eight officers of various grades were promoted in year 2019. The Excellent
Service Award was granted to a total of five MDA employees in year 2020 whom are
four management professionals and one executor. Furthermore, number of client
complaints about the performance and safety of medical equipments was 642 in year
2018 and increased slightly to 965 in next year. In year 2019, 98 reports on the
performance and safety of clinical devices were acquired, but in year 2020, the number
of reports in this category declined to 30. In addition, MDA received 170 complaints, or
30% of user comments and concerns, about various issues with the FEMES device. In
order to strengthen their organisation, MDA worked well with other parties. As a result,
in year 2019 they hosted international relation conferences both domestically and
abroad alongside the Asian Harmonization Working Party and the Asean Medical
Device Committee. MDA also formed and gathered MDA-Industry Collaborative
Committee (MICC) assembly. Moreover, MDA also worked with other ministries such as
the Medical Device Investment Advisory Panel, Ministry of International Trade and
Industry and Royal Malaysian Customs Department in year 2020.

Performance and Evaluation

Performance evaluation is referred as a formal method for rating an employee's work in
accordance with their job responsibilities. In year 2018, there was not a focused and
finished major performance whereby in year 2019, technical operations which supported
support ICT application system has been effectively progressed, with the objective of
completing 4 guidance files. Next, the Medical Devices Authority collected
RM10,483,350 in total sales as for year 2020, which is 153.9% more than the initial
target of RM6,808,251 achieved in the same year. The MDA has approved a total of
361 new established order license applications as a result and outcome of software in
the same year. A total of 449 licenses were subsequently renewed. Then, a total of 443
product type letters were issued after 423 product categorization programmes had been
obtained and processed. A
total of 8,215 scientific device
registration applications
and 4,924 exchange
notification programmes
were received in year 2019,
which the MDA assessed and
registered.
Appendices

Figure 1 shows the organizational structure of the Board of Directors in the year 2018.
Figure 2 shows the launch of the Malaysian Medical Device Expo (MYMEDEX) and the
International Medical Device Conference (IMDC) which was organized by MDA in the
year 2019.
Figure 3 shows employees that received excellent service award (APC) in year 2018.
Figure 4 shows that an interview given by Pn. Salbiah Binti Yaakop, Senior Assistant
Director, Policy Division, Code and Standard on understanding of the medical device in
year 2019.