/akn/my/act/pua/2024/24

PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024

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Type: P.U. (A)
Status: In force
Enacted: 2024
Sections: 8

Quick answer

About this p.u. (a)

PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024 is Malaysia P.U. (A), cited as P.U. (A) 24 2024, currently marked in force and first recorded in 2024.

Opening note

Preamble

PADA menjalankan kuasa yang diberikan oleh seksyen 71 dan 79 Akta Peranti Perubatan 2012 [Akta 737], Menteri membuat peraturan-peraturan yang berikut: Nama

Seksyen 1

Peraturan-peraturan ini bolehlah dinamakan Peraturan-Peraturan Peranti

Perubatan (Pengkompaunan Kesalahan) 2024.

Seksyen 2

Kesalahan yang boleh dikompaun

(1)

Kesalahan yang dinyatakan dalam Jadual Pertama ditetapkan sebagai kesalahan yang boleh dikompaun.

(2)

Kesalahan yang boleh dikompaun itu boleh dikompaun dengan keizinan

Pendakwa Raya dalam Borang 1 Jadual Kedua.

Tatacara mengkompaun

Seksyen 3

(1)

Apabila menerima apa-apa maklumat atau aduan bahawa suatu kesalahan yang boleh dikompaun telah dilakukan, Pihak Berkuasa boleh, dengan keizinan

Pendakwa Raya yang disebut dalam subperaturan 2(2), mengeluarkan suatu tawaran untuk mengkompaun kesalahan itu dalam Borang 2 Jadual Kedua.

(2)

Suatu tawaran untuk mengkompaun suatu kesalahan adalah sah bagi tempoh empat belas hari bermula dari tarikh tawaran itu diterima oleh orang yang kepadanya tawaran itu dibuat atau apa-apa tempoh lanjutan yang boleh diberikan oleh Pihak Berkuasa, dan jika pembayaran penuh bagi jumlah yang ditawarkan itu dibuat pada atau sebelum habis tempoh empat belas hari atau apa-apa tempoh lanjutan yang diberikan itu, tiada prosiding selanjutnya boleh diambil terhadap orang yang telah melakukan kesalahan itu.

P.U. (A) 24 3

Penyetujuterimaan kompaun

Seksyen 4

Seseorang yang menyetuju terima suatu tawaran untuk mengkompaun suatu kesalahan yang boleh dikompaun hendaklah menyetuju terima tawaran itu dalam Borang 3 Jadual Kedua dan mengembalikan Borang 3 itu kepada Pihak Berkuasa.

Seksyen 5

Pembayaran kompaun

(1)

Jika suatu tawaran untuk mengkompaun suatu kesalahan disetuju terima oleh orang yang kepadanya tawaran itu dibuat, dia hendaklah membayar kompaun itu melalui kiriman wang, wang pos, perintah juruwang, arahan bank atau draf bank dipalang dengan perkataan “Akaun Penerima Sahaja” yang kena dibayar kepada Pihak Berkuasa.

(2)

Pembayaran kompaun yang dibuat di bawah subperaturan (1) hendaklah diserahkan sendiri atau dihantar melalui pos berdaftar prabayar ke alamat yang dinyatakan dalam Borang 2 Jadual Kedua.

(3)

Ketua Eksekutif Pihak Berkuasa hendaklah mengeluarkan suatu resit rasmi bagi tiap-tiap pembayaran yang diterima di bawah subperaturan (1)

kepada orang yang kepadanya tawaran untuk mengkompaun kesalahan itu telah dibuat.

Pendakwaan boleh dimulakan jika tiada pembayaran dibuat

Seksyen 6

Jika tiada pembayaran bagi kompaun yang ditawarkan itu dibuat dalam tempoh yang dinyatakan dalam subperaturan 3(2), pendakwaan boleh dimulakan tanpa notis selanjutnya.

P.U. (A) 24 4

Jadual

JADUAL PERTAMA

[Subperaturan 2(1)]

KESALAHAN YANG BOLEH DIKOMPAUN

Kesalahan yang berikut ditetapkan sebagai kesalahan yang boleh dikompaun:

(a)

kesalahan yang dilakukan di bawah peruntukan Akta Peranti Perubatan 2012

[Akta 737] seperti yang berikut:

(i)

subseksyen 19(2);

(ii)

subseksyen 27(2);

(iii)

subseksyen 31(2);

(iv)

subseksyen 40(2);

(v)

subseksyen 43(6);

(vi)

subseksyen 45(5);

(vii)

subseksyen 46(3); dan

(viii)

subseksyen 65(3).

(b)

kesalahan yang dilakukan di bawah peruntukan Peraturan-Peraturan Peranti

Perubatan 2012 [P.U. (A) 500/2012] seperti yang berikut:

(i)

subperaturan 7(7);

(ii)

subperaturan 10(7); dan

(iii)

subperaturan 16(4).

(c)

kesalahan yang dilakukan di bawah peruntukan Peraturan-Peraturan Peranti

Perubatan (Kewajipan dan Obligasi Establismen) 2019 [P.U. (A) 318/2019]

seperti yang berikut:

(i)

subperaturan 3(4);

(ii)

subperaturan 4(4);

(iii)

subperaturan 5(8);

(iv)

subperaturan 7(9); dan

(v)

subperaturan 8(6).

P.U. (A) 24 5

Jadual

JADUAL KEDUA

BORANG 1

[Subperaturan 2(2)]

KEIZINAN UNTUK MENGKOMPAUN KESALAHAN

PADA menjalankan kuasa yang diberikan oleh seksyen 71 Akta Peranti Perubatan 2012

[Akta 737]

dan subseksyen 376(3)

Kanun

Tatacara

Jenayah

[Akta 593], saya ……………………………………..………… (nama) dengan ini memberi keizinan untuk mengkompaun ………………………............................ (nama orang yang kepadanya tawaran kompaun itu dibuat) bagi kesalahan yang dilakukan di bawah ………………………………………

yang dikatakan telah dilakukan pada

………………………………….

(tarikh)

di ……………………………………… (tempat).

Tarikh:

.……………………………………………..

Pendakwa Raya/

Timbalan Pendakwa Raya

P.U. (A) 24 6

BORANG 2

[Subperaturan 3(1) dan 5(2)]

TAWARAN UNTUK MENGKOMPAUN KESALAHAN

Nombor rujukan: .......................................................

Tarikh : ........................................................

Pihak Berkuasa Peranti Perubatan

………………………….........….........................................

……………………………..........….....................................

Kepada:

………………………….........….........................................

……………………………..........….....................................

*Tuan/Puan,

Suatu penyiasatan telah dijalankan terhadap anda

........................................................................................ (nyatakan nama *individu/syarikat/perniagaan/badan lain, jika ada)

dan anda didapati telah melakukan kesalahan di bawah Akta Peranti Perubatan 2012

[Akta 737]/peraturan-peraturan yang dibuat di bawah Akta itu dengan butir-butir seperti yang berikut:

(a)

peruntukan **Akta/peraturan-peraturan yang berkaitan:

...........................................................................................................................................................................

P.U. (A) 24 7

...........................................................................................................................................................................

(b)

tarikh: ................................................................

(c)

masa: ..................................................................

(d)

tempat:...........................................................................................................................................................

(e)

butir-butir kesalahan:

...........................................................................................................................................................................

Menurut subseksyen 71(1) Akta Peranti Perubatan 2012 [Akta 737], dengan keizinan Pendakwa Raya, anda ditawarkan suatu kompaun bagi kesalahan yang dinyatakan di atas bagi jumlah wang sebanyak RM ............................ (.................................

(dalam perkataan) ringgit sahaja).

Sekiranya tawaran untuk mengkompaun ini disetuju terima, bayaran hendaklah dibuat melalui *kiriman wang/wang pos/perintah juruwang/arahan bank/draf bank dipalang dengan perkataan “Akaun Penerima Sahaja” yang kena dibayar kepada

Pihak Berkuasa Peranti Perubatan dan hendaklah diserahkan sendiri atau dihantar melalui pos berdaftar prabayar ke alamat yang berikut:

Ketua Eksekutif

Pihak Berkuasa Peranti Perubatan

.....................................................................

Suatu resit rasmi akan dikeluarkan apabila pembayaran kompaun itu diterima.

Tawaran untuk mengkompaun ini sah sehingga...............................................

P.U. (A) 24 8 6.

Jika tiada bayaran diterima dalam tempoh yang disebut dalam perenggan 5, pendakwaan bagi kesalahan itu boleh dimulakan terhadap anda/...............................................................(nyatakan *nama individu/syarikat/perniagaan/badan lain, jika ada)

tanpa notis selanjutnya.

Sekian, terima kasih.

..........................................................................

Ketua Eksekutif

Pihak Berkuasa Peranti Perubatan

* Potong mana-mana yang tidak berkenaan

**Nyatakan butir-butir dan gunakan lampiran jika perlu

P.U. (A) 24 9

BORANG 3

[Peraturan 4]

PENYETUJUTERIMAAN TAWARAN UNTUK MENGKOMPAUN KESALAHAN

Kepada:

Ketua Eksekutif

Pihak Berkuasa Peranti Perubatan

……………………………..................................................

…………………………...............................……................

*Tuan/Puan,

Saya merujuk kepada Tawaran untuk Mengkompaun Kesalahan dengan nombor rujukan

......................................................................... bertarikh .............................................. .

Saya mengaku bahawa saya telah melakukan kesalahan ini dan saya menerima tawaran untuk mengkompaun itu dan disertakan bersama-sama ini pembayaran melalui

*kiriman wang/wang pos/perintah juruwang/arahan bank/draf bank

No. ........................................................ dipalang dengan perkataan “Akaun Penerima Sahaja”

yang kena dibayar kepada Pihak Berkuasa Peranti Perubatan bagi jumlah wang sebanyak

RM ...................... ( ................................... (dalam perkataan) ringgit sahaja) sebagai penyelesaian penuh bagi jumlah wang yang dinyatakan dalam perenggan 2

Tawaran untuk Mengkompaun Kesalahan.

Tandatangan : ...........................................................................

Nama (dalam huruf besar) : ...........................................................................

No. *Kad Pengenalan/Pasport : ...........................................................................

P.U. (A) 24 10

Jawatan (jika berkenaan) : ............................................................................

Bagi pihak (jika berkenaan) : ............................................................................

*No. Pendaftaran Syarikat/No. Lesen/

No. Permit (jika berkenaan) : ………………………….…................…...............

Cap rasmi *syarikat/perniagaan/badan lain

(jika berkenaan) : ............................................................................

*No. Perakuan Pendaftaran Peranti

Perubatan/No. Lesen Establismen : ..............................................................................

Alamat:

.......................................................................................................................................................................................

Tarikh: ......................................................

*Potong mana-mana yang tidak berkenaan

Dibuat 19 Januari 2024

[KKMMDA(S)100/1-1-1; PN(PU2)711/V]

DATUK SERI DR. HAJI DZULKEFLY BIN AHMAD

Menteri Kesihatan

(nama *syarikat/perniagaan atau badan lain)

P.U. (A) 24 11

MEDICAL DEVICE (COMPOUNDING OF OFFENCES) REGULATIONS 2024

IN exercise of the powers conferred by sections 71

and 79

of the Medical Device Act 2012 [Act 737], the Minister makes the following regulations:

Citation 1.

These regulations may be cited as the Medical Device (Compounding of

Offences) Regulations 2024.

Compoundable offences 2.

(1)

The offences specified in the First Schedule are prescribed to be compoundable offences.

(2)

The compoundable offences may be compounded with the consent of the Public Prosecutor in Form 1 of the Second Schedule.

Procedure for compounding 3.

(1)

Upon receipt of any information or complaint that an offence which may be compounded has been committed, the Authority may, with the consent of the Public Prosecutor referred to in subregulation 2(2), issue an offer to compound the offence in Form 2 of the Second Schedule.

(2)

An offer to compound an offence shall be valid for a period of fourteen days starting from the date the offer is received by the person to whom offer is made or such extended period as the Authority may grant, and if full payment of the sum offered is made on or before the expiry of fourteen days or such extended period granted, no further proceedings shall be taken against the person who committed such offence.

Acceptance of compound 4.

A person who accepts an offer to compound an offence which may be compounded shall accept the offer in Form 3 of the Second Schedule and return Form 3

to the Authority.

P.U. (A) 24 12

Payment of compound 5.

(1)

If an offer to compound an offence is accepted by the person to whom the offer is made, he shall pay the compound by money order, postal order, cashier’s order, banker’s order or bank draft crossed with the words

“Account Payee Only” made payable to the Authority.

(2)

The payment of compound made under subregulation (1) shall be delivered personally or sent by prepaid registered post to the address specified in Form 2 of the Second Schedule.

(3)

The Chief Executive of the Authority shall issue an official receipt for every payment received under subregulation (1) to the person to whom the offer to compound an offence is made.

Prosecution may be instituted if no payment made 6.

If no payment of the compound offered is made within the period specified in subregulation 3(2), prosecution may be instituted without further notice.

P.U. (A) 24 13

FIRST SCHEDULE

[Subregulation 2(1)]

COMPOUNDABLE OFFENCES

The following offences are prescribed to be compoundable offences:

(a)

the offences committed under the provisions of the Medical Device Act 2012

[Act 737] as follows:

(i)

subsection 19(2);

(ii)

subsection 27(2);

(iii)

subsection 31(2);

(iv)

subsection 40(2);

(v)

subsection 43(6);

(vi)

subsection 45(5);

(vii)

subsection 46(3); and

(viii)

subsection 65(3).

(b)

the offences committed under the provisions of the Medical Device

Regulations 2012 [P.U. (A) 500/2012] as follows:

(i)

subregulation 7(7);

(ii)

subregulation 10(7); and

(iii)

subregulation 16(4).

(c)

the offences committed under the provisions of the Medical Device (Duties and

Obligations of Establishments) Regulations 2019 [P.U. (A) 318/2019] as follows:

(i)

subregulation 3(4);

(ii)

subregulation 4(4);

(iii)

subregulation 5(8);

(iv)

subregulation 7(9); and

(v)

subregulation 8(6).

P.U. (A) 24 14

SECOND SCHEDULE

FORM 1

[Subregulation 2(2)]

CONSENT TO COMPOUND OFFENCES

IN exercise of the powers conferred by section 71 of the Medical Device Act 2012

[Act 737] and subsection 376(3) of the Criminal Procedure Code [Act 593],

…………………………………..………….

(name)

hereby give consent to compound

………………………………….………..…. (name of the person to whom the compound offer is made)

for the offence committed under …………………………………………..……. which is said to be committed on ……………….. (date) at ……………………….…………..…….. (place).

Date:

…………………………………………………….

Public Prosecutor/

Deputy Public Prosecutor

P.U. (A) 24 15

FORM 2

[Subregulations 3(1) and 5(2)]

OFFER TO COMPOUND OFFENCE

Reference number: .............................................

Date : ..............................................

Medical Device Authority

…………………………….....................................

………………………………..................................

To:

…………………………….....................................

………………………………..................................

*Sir/Madam,

An investigation has been conducted against you

............................................................................................... (state name of *individual/company/business/other body, if any)

and you are found to have committed the offence under the Medical Device Act 2012

[Act 737]/regulations made under the Act with the following particulars:

(a)

relevant provision of the **Act/regulations:

...........................................................................................................................................................................

P.U. (A) 24 16

...........................................................................................................................................................................

(b)

date: .................................................

(c)

time: .................................................

(d)

place: ..............................................................................................................................................................

(e)

particulars of offence:

...........................................................................................................................................................................

Pursuant to subsection 71(1) of the Medical Device Act 2012 [Act 737], with the consent of the Public Prosecutor, you are offered a compound for the offence stated above for the sum of RM ............................... (............................................... (in words)

ringgit only).

If this offer to compound is accepted, payment shall be made by

*money order/postal order/cashier’s order/banker’s order/ bank draft crossed with the words “Account Payee Only” made payable to the Medical Device Authority and shall be delivered personally or sent by prepaid registered post to the following address:

Chief Executive

Medical Device Authority

..................................................................

An official receipt shall be issued on receipt of the payment of the compound.

This offer to compound shall be valid until………………………………

P.U. (A) 24 17 6.

If no payment is received within the period referred to in paragraph 5, the prosecution for the offence may be instituted against you/……………………………….….

(state name of *individual/company/business/other body, if any) without further notice.

Thank you.

............................................................................

Chief Executive

Medical Device Authority

* Delete whichever is inapplicable

**State the particulars and use appendix if necessary

P.U. (A) 24 18

FORM 3

[Regulation 4]

ACCEPTANCE OF OFFER TO COMPOUND OFFENCE

To:

Chief Executive

Medical Device Authority

……………………………...................

………………………………................

*Sir/Madam,

I refer to the Offer to Compound Offence bearing the reference number

.................................................................. dated ................................. .

I admit that I have committed this offence and I accept the offer to compound and enclose herewith is the payment by

*money order/postal order/

cashier’s order/banker’s order/bank draft No. .......................................................... crossed with the words “Account Payee Only” made payable to the Medical Device Authority for the sum of RM ................................ (…….................................. (in words) ringgit only)

as full settlement of the sum stipulated in paragraph 2 of the Offer to Compound Offences.

Signature : ................................................................................

Name (in capital letters) : .................................................................................

*Identification Card/Passport No. : .................................................................................

Designation (if applicable) : .................................................................................

P.U. (A) 24 19

On behalf of (if applicable) : .................................................................................

*Company Registration No. /Licence No. /

Permit No. (if applicable) : …………………………………….………………..

Official stamp of *company/business/

other body (if applicable) : …………………………………………….………….

*Certificate of Registration of Medical

Device No./Establishment Licence No. : ................................................................................

Address:

.......................................................................................................................................................................................

Date: ..........................................................

*Delete whichever is inapplicable

Made 19 January 2024

[KKMMDA(S)100/1-1-1; PN(PU2)711/V]

DATUK SERI DR. HAJI DZULKEFLY BIN AHMAD

Minister of Health

(name of *company/business or other body)

Common questions

What is PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024?: PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024 is Malaysia P.U. (A), cited as P.U. (A) 24 2024, currently marked in force and first recorded in 2024.
Is PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024 still in force?: Yes — PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024 is currently in force.
When did PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024 take effect?: PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024 was first recorded in 2024.
How many sections does PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024 have?: PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024 contains 6 sections.
Where can I read the official version of PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024?: The official text of PERATURAN-PERATURAN PERANTI PERUBATAN (PENGKOMPAUNAN KESALAHAN) 2024 is published at lom.agc.gov.my.