What is Perintah Peranti Perubatan (Pengecualian) 2016?

Perintah Peranti Perubatan (Pengecualian) 2016 is Malaysia P.U. (A), cited as P.U. (A) 103 2016, currently marked in force and first recorded in 2016.

Is Perintah Peranti Perubatan (Pengecualian) 2016 still in force?

Yes — Perintah Peranti Perubatan (Pengecualian) 2016 is currently in force.

How many sections does Perintah Peranti Perubatan (Pengecualian) 2016 have?

Perintah Peranti Perubatan (Pengecualian) 2016 contains 7 sections.

Where can I read the official version of Perintah Peranti Perubatan (Pengecualian) 2016?

The official text of Perintah Peranti Perubatan (Pengecualian) 2016 is published at lom.agc.gov.my.

P.U. (A)In force

Perintah Peranti Perubatan (Pengecualian) 2016

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Enacted: 2016
Sections: 7

Front matterCover and publication detailsOpen

P.U. (A) 103

WARTA KERAJAAN PERSEKUTUAN

FEDERAL GOVERNMENT

GAZETTE

PERINTAH PERANTI PERUBATAN

(PENGECUALIAN) 2016

MEDICAL DEVICE (EXEMPTION)

ORDER 2016

DISIARKAN OLEH/

JABATAN PEGUAM NEGARA/

ATTORNEY GENERAL’S CHAMBERS

P.U. (A) 103 2

AKTA PERANTI PERUBATAN 2012

PERINTAH PERANTI PERUBATAN (PENGECUALIAN) 2016

Opening note

Preamble

PADA menjalankan kuasa yang diberikan oleh subseksyen 77(1) Akta Peranti Perubatan 2012 [Akta 737], Menteri, demi kepentingan kesihatan dan keselamatan awam, membuat perintah yang berikut: Nama

Seksyen 1

Perintah ini bolehlah dinamakan Perintah Peranti Perubatan (Pengecualian)

Seksyen 2016

Tafsiran

Seksyen 2

Dalam Perintah ini—

“kajian klinikal” ertinya penyiasatan sistematik atau kajian kepada manusia yang dilakukan untuk menilai keselamatan dan prestasi sesuatu peranti perubatan;

“kegunaan peribadi” ertinya peranti perubatan yang di bawa masuk ke dalam

Malaysia bagi kegunaan seorang individu tertentu dan tidak boleh diletakkan di dalam pasaran;

“peranti perubatan akses khas” ertinya peranti perubatan bagi kegunaan mana-mana pengamal perubatan dalam situasi kecemasan atau dalam keadaan apabila rawatan perubatan konvensional gagal, tidak tersedia atau tidak sesuai;

“peranti perubatan yang dibuat khas” ertinya peranti perubatan yang dibuat dengan ciri reka bentuk spesifik mengikut preskripsi bertulis seorang pengamal perubatan dan bertujuan untuk kegunaan seseorang pesakit yang tertentu.

P.U. (A) 103 3

Seksyen 3

Pengecualian daripada pendaftaran peranti perubatan

(1)

Menteri mengecualikan apa-apa peranti perubatan daripada seksyen 5

Akta jika peranti perubatan tersebut adalah—

(a)

bagi tujuan kegunaan peribadi;

(b)

bagi tujuan demonstrasi pemasaran;

(c)

bagi tujuan pendidikan;

(d)

bagi tujuan penyelidikan klinikal atau untuk penilaian prestasi peranti perubatan;

(e)

peranti perubatan yang dibuat khas; atau

(f)

peranti perubatan akses khas.

(2)

Seseorang yang mengimport atau mengilang apa-apa peranti perubatan di bawah subperenggan (1)(b), (c), (d), (e) atau (f) hendaklah memaklumkan

Pihak Berkuasa secara bertulis mengenai pengecualian tersebut.

Seksyen 4

Pengecualian daripada lesen establismen

Seseorang yang mengimport atau mengilang peranti perubatan di bawah perenggan 3 adalah dikecualikan daripada keperluan lesen establismen di bawah subseksyen 15(1) Akta.

Seksyen 5

Pengecualian daripada penilaian pematuhan bagi peranti perubatan Kelas A

Suatu peranti perubatan Kelas A adalah dikecualikan daripada tatacara penilaian pematuhan oleh badan penilaian pematuhan di bawah seksyen 7 Akta.

P.U. (A) 103 4

Dibuat 8 April 2016

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

DATUK SERI DR. S. SUBRAMANIAM

Menteri Kesihatan

P.U. (A) 103 5

MEDICAL DEVICE ACT 2012

MEDICAL DEVICE (EXEMPTION) ORDER 2016

Opening note

Preamble

IN exercise of the power conferred by subsection 77(1) of the Medical Device Act 2012 [Act 737], the Minister, in the interest of public health and safety, makes the following order: Citation 1. This order may be cited as the Medical Device (Exemption) Order 2016. Interpretation 2. In this Order— “clinical research” means a systematic investigation or study to human beings undertaken to assess the safety and performance of a medical device; “personal use” means a medical device which is brought into Malaysia for the use of a particular individual only and not to be placed in the market; “special access medical device” means a medical device for the use of medical practitioners in emergency situations or in the event that conventional medical treatment has failed, is unavailable or unsuitable; “custom-made medical device” means a medical device made with specific design characteristics in accordance with a medical practitioner’s written prescription and is intended to be used for a particular patient. Exemption from registration of medical devices 3.

(1)

The Minister exempts any medical device from section 5 of the Act if the medical device is—

(a)

for the purpose of personal use;

P.U. (A) 103 6

(b)

for the purpose of demonstration for marketing;

(c)

for the purpose of education;

(d)

for the purpose of clinical research or performance evaluation of medical device;

(e)

a custom-made medical device; or

(f)

a special access medical device.

(2)

A person who imports or manufactures any medical device under subparagraph (1)(b), (c), (d), (e) or (f) shall notify the Authority in writing of the exemption.

Exemption from establishment license 4.

A person who imports or manufactures medical device under paragraph 3 is exempted from the requirement of an establishment license under subsection 15(1) of the Act.

Exemption from conformity assessment for Class A medical device

Seksyen 5

A Class A medical device is exempted from the conformity assessment procedures by a conformity assessment body under section 7 of the Act.

Made 8 April 2016

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

DATUK SERI DR. S. SUBRAMANIAM

Minister of Health

Common questions

What is Perintah Peranti Perubatan (Pengecualian) 2016?: Perintah Peranti Perubatan (Pengecualian) 2016 is Malaysia P.U. (A), cited as P.U. (A) 103 2016, currently marked in force and first recorded in 2016.
Is Perintah Peranti Perubatan (Pengecualian) 2016 still in force?: Yes — Perintah Peranti Perubatan (Pengecualian) 2016 is currently in force.
When did Perintah Peranti Perubatan (Pengecualian) 2016 take effect?: Perintah Peranti Perubatan (Pengecualian) 2016 was first recorded in 2016.
How many sections does Perintah Peranti Perubatan (Pengecualian) 2016 have?: Perintah Peranti Perubatan (Pengecualian) 2016 contains 7 sections.
Where can I read the official version of Perintah Peranti Perubatan (Pengecualian) 2016?: The official text of Perintah Peranti Perubatan (Pengecualian) 2016 is published at lom.agc.gov.my.

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