MENTERI KESEHATAN MINISTER OF HEALTH OF THE...

MENTERI KESEHATAN

REPUBLIK INDONESIA

MINISTER OF HEALTH OF THE REPUBLIC OF

INDONESIA

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Formulir 3 Form 3

KOP DINAS KESEHATAN PROVINSI LETTERHEAD OF THE PROVINCIAL

HEALTH OFFICE

Nomor: …………………… Number: ………………

Lampiran: …………………… Enclosure: ………………

Perihal: Rekomendasi Hasil Pemeriksaan

Sertifikat Produksi Alat

Kesehatan/Perbekalan Kesehatan

Rumah Tangga

Subject: Recommendation for the Inspection

Results on the Certificate of

Production of Medical

Devices/Household Medical Products

Kepada Yth. To.

Direktur Jenderal Bina Kefarmasian dan

Alat Kesehatan Kementerian Kesehatan

Rl

Director General of Guidance of

Pharmaceutical and Medical Devices

of the Ministry of Health of the

Republic of Indonesia

di- In-

JAKARTA JAKARTA

Sehubungan dengan surat permohonan

dari ....... Nomor ........... tanggal.........

perihal seperti pada pokok surat di atas,

maka bersama ini kami sampaikan:

With regard to the letter of application

from ....... Number ....... dated .......

regarding the above letter subject, we

herewith would like to inform:

Sesuai dengan Berita Acara

Pemeriksaan Tim Pemeriksaan

Bersama ke Alamat kantor,

Produksi dan Gudang ……Jalan

……maka perusahaan tersebut

memenuhi /tidak memenuhi persyaratan

berdasarkan Peraturan Menteri

Kesehatan Nomor

1189/MENKES/PER/VIII/2010 tentang

In accordance with the Report of

Inspection by the Joint Inspection

Team at the Office Address,

Production and …..... Warehouse at

Jalan ……, such company

complies/does not comply with the

requirements based on the Regulation

of the Minister of Health Number

1189/MENKES/PER/VIII/2010

MENTERI KESEHATAN

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INDONESIA

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Produksi Alat Kesehatan dan

Perbekalan Kesehatan Rumah Tangga.

regarding the Production of Medical

Devices and Household Products.

Bersama ini kami lampirkan: We herewith attach:

1. Salinan/copy surat permohonan

yang bersangkutan beserta

lampiran – lampirannya.

1. Copy of the concerned

application including its

enclosures.

2. Berita Acara Pemeriksaan. 2. Report of Inspection.

Kepala Head

Dinas Kesehatan Provinsi, Provincial Health Office,

(………………………………) (………………………………)

NIP………………. Reg. No.……………….

Tembusan Kepada Yth. Copies To.

1. Kepala Dinas Kesehatan Kabupaten/Kota di. 1. Head of the District/City Health Office in

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

2. Pimpinan Perusahaan .................... di ……. 2. Company Management of ............. in …….

MENTERI KESEHATAN

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Formulir 4 Form 4

Nomor: ……… Number: ………

Lampiran: Enclosure:

Perihal: Pernyataan Siap Beroperasi Pabrik Alat


Rumah Tangga

Subject: Statement of Ready to Operate of the

Medical Devices/Household Products

Manufacturer

Kepada Yth. To.


Alat Kesehatan Kementerian Kesehatan

Rl

Director General of Guidance on


of the Ministry of Health of the

Republic of Indonesia

di- In-

JAKARTA JAKARTA

Sehubungan surat permohonan kami

Nomor ........ Tanggal .........dan sesuai

ketentuan Peraturan Menteri Kesehatan

Nomor 1189/MENKES/PER/VIII/2010

tentang Produksi Alat Kesehatan dan

Perbekalan Kesehatan Rumah Tangga,

dengan ini kami sampaikan bahwa

Perusahaan kami telah siap

melaksanakan kegiatan produksi Alat


Rumah tangga yang beralamat di

jalan…….

With regard to our letter of application

Number ........ Dated ......... and in

accordance with the Regulation of the

Minister of Health Number



Devices and Household Products, we

herewith inform that our Company is

ready to implement the production

activities of Medical

Devices/Household Products, having

the address at Jalan……

Demikianlah untuk diketahui dan atas

perhatiannya diucapkan terima kasih.

Please be informed and thank you for

your attention.

Direktur/ Pimpinan Perusahaan, Director/Company Management,

(………………………………) (………………………………)

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Tembusan Yth. Copies to.

1. Kepala Dinas Kesehatan Provinsi........... 1. Head of Provincial Health Office of ...........

2. Kepala Dinas Kesehatan Kabupaten/Kota… 2. Head of District/City Health Office of ……..

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

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Formulir 5 Form 5

KEPUTUSAN DIREKTUR JENDERAL BINA

KEFARMASIAN DAN ALAT KESEHATAN

KEMENTERIAN KESEHATAN REPUBLIK

INDONESIA

DECREE OF THE DIRECTOR GENERAL OF

PHARMACEUTICAL AND MEDICAL

DEVICES DEVELOPMENT OF THE

MINISTRY OF HEALTH OF THE REPUBLIC

OF INDONESIA

NOMOR: ........................... NUMBER: ...........................

TENTANG REGARDING

SERTIFIKAT PRODUKSI ALAT KESEHATAN CERTIFICATE OF PRODUCTION OF

MEDICAL DEVICES

DIREKTUR JENDERAL BINA


DIRECTOR GENERAL GUIDANCE ON


DEVICES

Membaca : 1. Surat permohonan (Nama

Badan Usaha)..., (Nama

Kota)… Nomor ...... Tanggal

...... tentang Permohonan


Kesehatan;

Reading : 1. The Letter of application of

(Name of Business

Company)...., (Name of

City)… Number.......Dated

.......... regarding the

Application for the

Certificate of Medical

Devices Production;

2. Berita Acara Pemeriksaan

Dinas Kesehatan Provinsi......

Nomor. tanggal...........

2. Report of Inspection of the

Provincial Health Office of

....... Number dated...........

3. Rekomendasi dari Dinas

Kesehatan Provinsi......

Nomor....... tanggal.........;

3. Recommendation from the

Provincial Health Office

Number ............ dated.......;

Menimbang : bahwa permohonan (Nama

Badan Usaha)......, (Nama

Considering : That such applicationapplication

of (Name of Business

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Kota)......tersebut dapat disetujui,

oleh karena itu perlu menerbitkan

Sertifikat Produksi Alat Kesehatan;

Company)......(Name of

City)......can be approved, and

therefore, it is necessary to issue

the Certificate of Medical Devices

Production;

Mengingat : Peraturan Menteri Kesehatan

Nomor

1189/MENKES/PER/VI11/2010

tentang Produksi Alat Kesehatan

dan Perbekalan Kesehatan Rumah

Tangga;

In view of : Regulation of the Minister of

Health Number

1189/MENKES/PER/VI11 /2010

regarding Production of Medical

Devices and Household

Products

MEMUTUSKAN: HAS DECREED:

Menetapkan : To Stipulate :

Kesatu : Memberikan Sertifikat Produksi Alat

Kesehatan kepada :

First : Provide the Certificate of Medical

Devices Production to:

Nama Perusahaan: Name of Company:

NPWP: Taxpayer Reference Number:

Alamat Perusahaan: Address of Company:

Nama Direktur/Pimpinan: Name of Director/Management:

Nama Penanggung Jawab Teknis Name of Technical Responsible

Person

Alamat Pabrik: Manufacturer Address:

Alamat Gudang; Warehouse Address:

Kedua : Sertifikat Produksi Alat Kesehatan

sebagaimana dimaksud Diktum

Kesatu temasuk Kelas ... dengan

ketentuan sebagai berikut:

Second : The Certificate of Medical

Devices Production, as meant in

Dictum One includes the Class

..... with the following provisions:

1. Harus selalu diawasi oleh

penanggung jawab teknis

yang namanya tercantum

pada Surat Keputusan ini.

1. Should always be controlled

by the technical responsible

person whose name is

indicated in this Decree.

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2. Menerapkan Pedoman Cara

pembuatan Alat Kesehatan

yang Baik (CPAKB).

2. Applies the Guidelines on

Good Manufacturing

Practices of Medical

Devices.

3. Harus memberikan laporan

hasil produksi setiap 1 (satu)

tahun sekali kepada Direktur

Jenderal Bina Kefarmasian

dan Alat Kesehatan, tembusan

kepada Dinas Kesehatan

Provinsi dan Kabupaten/Kota

sesuai lokasi.

3. Should submit the production

report once every 1 (one)

year to the Director General

of Guidance on

Pharmaceutical and Medical

Devices with copies to the

Provincial Health Office and

District/City Health Office

according to the location.

4. Memiliki laboratorium sendiri

atau bekerja sama dengan

laboratorium yang diakui untuk

melakukan analisa dan

pemeriksaan terhadap bahan

produksi yang digunakan dan

produk akhir.

4. In possession of an own

laboratory or collaborates

with a recognized laboratory

to carry out the analysis and

inspection on the production

materials that are used and

the finished products.

5. Melaksanakan produksi Alat

Kesehatan sesuai dengan

Peraturan Menteri Kesehatan

Nomor


tentang Produksi Alat

Kesehatan dan Perbekalan

Kesehatan Rumah Tangga,

dan peraturan lainnya yang

terkait.

5. Implements the

production of Medical

Devices according to the

Regulation of the Minister

of Health Number

1189/MENKES/PER/

VIII/2010 regarding

Production of Medical

Devices and Household

Products as well as other

related regulations.

Ketiga : Sertifikat Produksi berlaku 5 (lima)

tahun terhitung sejak tanggal

Third : The Production Certificate is valid

for 5 (five) years effective as of

MENTERI KESEHATAN

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dikeluarkan. the date of issuance.

Keempat : Keputusan ini mulai berlaku pada

tanggal ditetapkan dengan

ketentuan akan diadakan

peninjauan atau perbaikan

sebagaimana mestinya apabila

terdapat kekeliruan dalam

penetapan ini.

Fourth : This Decree commences effective

on the date of enactment with the

provision that appropriate review

or revision will be made in case of

any mistakes in this enactment.

Ditetapkan di Jakarta Enacted in Jakarta

Pada tanggal............ On the date of............

DIREKTUR JENDERAL, DIRECTOR GENERAL,

NIP………………………. Reg. No……………………….


1. Kepala Dinas Kesehatan Provinsi........ 1. Head of Provincial Health Office of ……….….

2. Kepala Dinas Kesehatan Kabupaten/Kota .... 2. Head of District/City Health Office of ……..

3. Direktur Jenderal Perdagangan Dalam Negeri di

Jakarta.

3. Director General of Domestic Trade in Jakarta.

4. Direktur Jenderal Bea dan Cukai di Jakarta. 4. Director General of Customs in Jakarta.

MENTERI KESEHATAN

REPUBLIK INDONESIA


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LAMPIRAN KEPU TUSAN DIREKTUR

JENDERAL BINA KEFARMASIAN DAN ALAT

KESEHATAN KEMENTERIAN KESEHATAN

APPENDIX OF THE DECREE OF THE

DIRECTOR GENERAL OF GUIDANCE ON

PHARMACEUTICAL AND MEDICAL DEVICE

OF THE MINISTRY OF HEALTH

NOMOR : ………………… NUMBER : ………………

TANGGAL : ………………… DATE : ………………

Jenis Alat Kesehatan yang diizinkan diproduksi: Types of Medical Devices permitted to be

produced:

PERALATAN ………………….. DEVICE …………………..

- ………………….. - …………………..

- ………………….. - …………………..


- ………………….. - …………………..

- ………………….. - …………………..

Jenis Alat Kesehatan yang diizinkan dikemas

ulang dan di uji ulang :

Types of Medical Devices permitted to be

repacked and retested:

PERALATAN.................................... DEVICE ....................................

- ………………….. - …………………..

- ………………….. - …………………..


- ………………….. - …………………..

- ………………….. - …………………..

Jenis Alat Kesehatan yang diizinkan dirakit: Types of Medical Devices permitted to be

assembled:

PERALATAN………………….. DEVICE …………………..

- ………………….. - …………………..

- ………………….. - …………………..

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PERALATAN.................................... DEVICE....................................

- ………………….. - …………………..

- ………………….. - …………………..

Jenis Alat Kesehatan yang diizinkan

direkondisi/remanufakturing :

Types of Medical Devices permitted to be

reconditioned / remanufactured.


- ………………….. - …………………..

- ………………….. - …………………..

PERALATAN.................................... DEVICE....................................

- ………………….. - …………………..

- ………………….. - …………………..

Dengan ketentuan bahwa Alat Kesehatan tersebut

harus mendapatkan persetujuan izin edar sebelum

diedarkan.

With the provision that such Medical Devices should

obtain the approval for marketing license before being

marketed.


……………………………………. …………………………………….

NIP. NIP.

MENTERI KESEHATAN

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Formulir 6 Form 6

KEPUTUSAN DIREKTUR J ENDERAL BINA



INDONESIA


GUIDANCE ON PHARMACEUTICAL AND

MEDICAL DEVICES OF THE MINISTRY OF

HEALTH OF THE REPUBLIC OF

INDONESIA

NOMOR: ........................... NUMBER: ...........................

TENTANG REGARDING

SERTIFIKAT PRODUKSI PERBEKALAN

KESEHATAN RUMAH TANGGA

CERTIFICATE OF HOUSEHOLD PRODUCTS

PRODUCTION

DIREKTUR JENDERAL BINA KEFARMASIAN

DAN ALAT KESEHATAN,



DEVICES,


Badan Usaha) …., (Nama

Kota)… Nomor… Tanggal…

tentang Permohonan

Sertifikat Produksi

Perbekalan Kesehatan

Rumah Tangga;

Reading : 1. The Letter of Application of

(Name of Business

Company)…., (Name of

City)….. Number…..

Date….. regarding the

Application for the

Household Products

Production Certificate;


Dinas Kesehatan Provinsi…

Nomor….. Tanggal…..;

2. Report of Inspection of the

Provincial Health office…..

Number….. Dated…..;


Kesehatan Provinsi…..

Nomor….. Tanggal……


Provincial Health office…..

Number….. Dated……

Menimbang : bahwa permohonan (Nama Considering : That the application of (Name of

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Badan Usaha)......, (Nama

Kota)......tersebut dapat disetujui,

oleh karena itu perlu menerbitkan

Sertifikat Produksi Perbekalan

Kesehatan Rumah Tangga;

Business Company)......, (Name

of City)......can be approved, and


the Certificate of Household

Products Production;


Nomor



dan Perbekalan Kesehatan

Rumah Tangga;


Health Number


regarding Production of Medical

Devices and Household Products;


Menetapkan : To Stipulate :

Kesatu : Memberikan Sertifikat Produksi

Alat Kesehatan kepada :

First : Provide the Certificate of Medical

Devices Production to:

Nama Perusahaan: Name of Company:



Nama Direktur/Pimpinan: Name of Director:

Nama Penanggung Jawab Teknis Name of Technical Responsible

Person

Alamat Pabrik: Manufacturer Address:

Alamat Gudang: Warehouse Address:



Kesatu temasuk Kelas ... dengan


Second : The Certificate of Medical Devices

Production, as meant in the First

Dictum, includes the Class with the

following provisions:




pada Surat Keputusan ini.





2. Menerapkan Pedoman Cara 2. Applies the Good

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Produksi Perbekalan

Kesehatan Rumah Tangga

yang Baik (CPPKRTB)

dalam hal sarana,

dokumentasi, higiene dan

sanitasi.

Manufacturing Practices of

Household Products with

regard to the means,

documentation, hygiene, and

sanitation.





dan Alat Kesehatan,

tembusan kepada Dinas

Kesehatan Provinsi dan

Kabupaten/Kota sesuai

lokasi.

3. Should submit the report on

the results of production

once every 1 (one) year to

the Director General of

Guidance on Pharmaceutical

and Medical Devices with

copies to the Provincial

Health Office and





laboratorium yang diakui

untuk melakukan analisa dan



produk akhir.

4. In possession of its own

laboratory or collaborates with

a recognized laboratory to

carry out the analysis and

inspection on the production

materials that are used and

the finished products.

5. Melaksanakan produksi

Perbekalan Kesehatan

Rumah Tangga sesuai

dengan Peraturan Menteri

Kesehatan Nomor






5. Implements the production of

Household Products in

accordance with the

Regulation of the Minister of

Health Number


regarding Production of

Medical Devices and

Household Products and

other related regulations.

MENTERI KESEHATAN

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terkait.



dikeluarkan.

Third : The Certificate of Production is

valid for 5 (five) years effective as

of the date of issuance.

Keempat : Keputusan in! mulai berlaku pada






penetapan ini.



provision that appropriate review or

revision will be made in case of



Pada tanggal............ On the date of............


NIP………………………. Reg. No.……………………….


1. Dinas Kesehatan Provinsi........... 1. Provincial Health Office of...........

2. Dinas Kesehatan Kabupaten/Kota ............... 2. District/City Health Office of ...............


Jakarta.


4. Direktorat Jenderat Bea dan Cukai di Jakarta. 4. Directorate General of Customs in Jakarta.

MENTERI KESEHATAN

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LAMPIRAN KEPUTUSAN DIREKTUR JENDERAL

BINA KEFARMASIAN DAN ALAT KESEHATAN

KEMENTERIAN KESEHATAN

APPENDIX OF THE DECREE OF THE DIRECTOR

GENERAL OF GUIDANCE ON


DEVICES OF THE MINISTRY OF HEALTH

NOMOR : ............................ NUMBER: ............................

TANGGAL : ........................... DATE: ...........................

Jenis Perbekalan Kesehatan Rumah Tangga yang

diizinkan diproduksi:

Types of Household Products that are permitted to be

produced:

…………………………. ………………………….

………………………….. …………………………..

………………………….. …………………………..


diizinkan dikemas ulang dan di uji ulang :


repacked and retested::

…………………………. ………………………….

………………………….. …………………………..

………………………….. …………………………..

Dengan ketentuan bahwa Perbekalan Kesehatan

Rumah Tangga tersebut harus mendapatkan

persetujuan izin edar sebelum diedarkan.

With the provision that such Household Products

should obtain approval for the marketing permit

before being marketed.


……………………………… …………………………..

NIP. Reg. No.

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Formulir 7 Form 7

KEMENTERIAN KESEHATAN Rl MINISTRY OF HEALTH OF THE REPUBLIC

OF INDONESIA

DIREKTORAT JENDERAL BINA


DIRECTORATE GENERAL OF GUIDANCE

ON PHARMACY AND MEDICAL DEVICES

Nomor : ………… Number : ……………

Lampiran : -- Enclosure : --

Perihal : Penundaan Penerbitan Sertifikat

Produksi Alat Kesehatan /

Perbekalan Kesehatan Rumah

Tangqa

Subject : Postponement of Issuance of the

Production Certificate of Medical

Devices / Household Products

Kepada Yth. To.

…………………. ………………….

…………………. …………………

di- in-

……………….. ………………..

Sehubungan dengan surat Saudara

Nomor……… Tanggal…… perihal

Permohonan Sertifikat Produksi Alat


Rumah Tangga, maka dengan ini

diberitahukan bahwa kami belum

dapat menyetujui permohonan

tersebut, karena:

With regard to your letter

Number…….. Dated …….

regarding the Application for


Devices/Household Products, it is

hereby notified that we cannot yet

approve such application since:

1. ……………………………………. 1. …………………………………….

2. ……………………………………. 2. …………………………………….

3. ……………………………………. 3. …………………………………….

Selanjutnya kepada Saudara kami minta melengkapi You are further on requested to complete such data

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kekurangan data tersebut selambat-lambatnya dalam

waktu 6 (enam) bulan sejak tanggal surat ini.

shortage within not later than 6 (six) months as of

the date of this letter.

Demikianlah untuk dimaklumi. Please be informed.


(………………………………..) (………………………………..)

NIP……………………… NIP. ………………………

Tembusan Yth. Copies to:


2. Dinas Kesehatan Kabupaten/Kota ............... 2. District/City Health Office of ...............

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Formulir 8 Form 8

KEMENTERIAN KESEHATAN Rl MINISTRY OF HEALTH OF THE REPUBLIC

OF INDONESIA

DIREKTORAT JENDERAL BINA


DIRECTORATE GENERAL OF GUIDANCE

ON PHARMACEUTICAL AND MEDICAL

DEVICES

Nomor : ………………….. Number : ………………………

Lampiran : Enclosure :

Perihal : Penolakan permohonan Sertifikat

Produksi Alat

Kesehatan/Perbekalan

Kesehatan Rumah Tangga.

Subject : Rejection on the application for the

Product Certificate of Medical

Devices / Household Products.

Kepada Yth. To.

………………… …………………

………………… …………………

di- in-

………………… …………………

Sesuai dengan permohonan


Kesehatan/Perbekalan

Kesehatan Rumah Tangga

Nomor…… tanggal….. atas

nama….. dengan lokasi…..

setelah kami adakan

pemeriksaan, ternyata

perusahaan Saudara tidak

memenuhi ketentuan perizinan

yang berlaku, yaitu:

According to the application for the


Devices/Household Products

Number…….. dated…… in the

name of…… with the location

at….., after conducting the

inspection, apparently your

company does not comply with

prevailing licensing provisions,

namely:

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1. …………………………… 1. ………………………………

2. …………………………… 2. ………………………………

3. …………………………… 3. ………………………………

4. …………………………… 4. ………………………………

Sehubungan dengan hal

tersebut di atas, permohonan

Saudara tidak dapat kami

setujui.

With regard to the above

mentioned matter, we cannot

approve your application.

Demikianlah untuk kiranya

menjadi perhatian Saudara.

The above is for your attention.


(………………………………..) (………………………………..)

NIP……………………… NIP. ………………………


1. Dinas Kesehatan Provinsi........... 1. Provincial Health Office of ..........

2. Dinas Kesehatan Kabupaten/Kota ……. 2. District/City Health Office of ...............

MENTERI KESEHATAN

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Formulir 9 Form 9



KEMENTERIAN KESEHATAN REPUBLIK INDONESIA


GUIDANCE ON PHARMACEUTICAL AND MEDICAL

DEVICES OF THE MINISTRY OF HEALTH OF THE

REPUBLIC OF INDONESIA

NOMOR: ........................... NUMBER: ...........................

TENTANG REGARDING

PERUBAHAN SERTIFIKAT PRODUKSI ALAT

KESEHATAN

AMENDMENT OF THE PRODUCTION CERTIFICATE

OF MEDICAL DEVICES

DIREKTUR JENDERAL BINA KEFARMASIAN DAN

ALAT KESEHATAN,


PHARMACEUTICAL AND MEDICAL DEVICES ,


Badan Usaha)…., (Nama

Kota)… Nomor….

Tanggal…. tentang

Permohonan

perubahan…. pada

Sertifikat Produks Alat

Kesehatan (sebutkan

perubahannya);

Reading : 1. Letter of Application of (Name

of Business Company)….

(Name of City)……

Number…. Dated…..

regarding Application for

amendment…… on the

Production Certificate of

Medical Devices (mention the

amendment);


Dinas Kesehatan

Provinsi…. Nomor…

Tanggal… (bila

diperlukan);

2. Formal Report of Inspection

of the Provincial Health

Office….. Number…..

Dated…… (if needed).


Kesehatan Provinsi…

Nomor….. Tanggal…..

(bila diperlukan);


Provincial Health Office…..

Number….. Dated…. (if

needed).

MENTERI KESEHATAN

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Menimbang : bahwa permohonan (Nama Badan

Usaha)…. (Nama Kota)…. tersebut

dapat disetujui, oleh karena itu

perlu menerbitkan Sertifikat

Produksi Alat Kesehatan;

Considering : that such application of (name of

Business Corporation)…. (Name

of City)…. can be approved, and


the Production Certificate for

Medical Devices.


Nomor




Tangga;


Health Number


regarding the Production of

Medical Devices and Household

Products.


Menetapkan : To Enact :

Kesatu : Memberikan Sertifikat Produksi Alat

Kesehatan kepada:

First : To provide the Production Certificate

of Medical Devices to:

Nama: Name:

Perusahaan: Company:




Nama Penanggung: Name of Technical:

Jawab Teknis: Responsible Person:

Alamat Pabrik: Address of Manufacturer:



Kesatu temasuk Kelas dengan


Second : The Production Certificate of Medical

Devices, as meant in the First

Dictum, includes the Class with the



penanggung jawab teknis yang

namanya tercantum pada

Surat Keputusan ini.





MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 78 -


produksi Alat Kesehatan yang

Baik (CPAKB) dalam hal

sarana, dokumentasi, hygiene

dan sanitasi.

2. Applies the Good


Medical Devices with regard

to the means, documentation,

hygiene and sanitation.





dan Alat Kesehatan, tembusan

kepada Dinas Kesehatan

Provinsi dan Kabupaten/Kota

sesuai lokasi.

3. Should submit the report of

production results once every

1 (one) year to the Director

General of Guidance on








laboratorium yang diakui untuk

melakukan analisa dan



produk akhir.

4. Has an own laboratory or

collaborate with a recognized

laboratory to carry out the

analysis and inspection on the

production materials that are

used and on the finished

products.




Nomor






terkait.


Medical Devices according to

the Regulation of the Minister

of Health Number



Medical Devices and

Household Products and





for 5 (five) years effective as of the

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 79 -

dikeluarkan. date of issuance.







penetapan ini.



provision that appropriate review

or revision will be made in case of



pada tanggal……………………….. On the date of ………………………..


(………………………………..) (………………………………..)

NIP……………………… NIP..………………………



2. Dinas Kesehatan Kabupaten/Kota…….. 2. District/City Health Office of ...............

3. Direktur Jenderal Perdagangan Dalam

Negeri di Jakarta.



MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 80 -

LAMPIRAN KEPUTUSAN DIREKTUR JENDERAL




GENERAL OF GUIDANCE ON PHARMACEUTICAL

AND MEDICAL DEVICES OF THE MINISTRY OF

HEALTH

NOMOR: ............................ NUMBER: ...........................

TANGGAL:........................... DATE: ...........................

Jenis Alat Kesehatan yang diizinkan diproduksi Type of Medical Devices permitted to be produced

PERALATAN .................................... DEVICE ....................................

- ……………….. - ………………..

- ……………….. - ………………..

Jenis Alat Kesehatan yang diizinkan dikemas ulang dan di

uji ulang

Type of Medical Devices permitted to be repacked and

retested:

PERALATAN................................... DEVICE ...................................

- ……………….. - ………………..

- ……………….. - ………………..

Jenis Alat Kesehatan yang diizinkan dirakit: Type of Medical Devices permitted to be assembled:

PERALATAN ................................... DEVICE ...................................

- ……………….. - ………………..

- ……………….. - ………………..

Jenis Alat Kesehatan yang diizinkan

direkondisi/remanufacturing

Type of Medical Devices permitted to be

reconditioned/remanufactured:

PERALATAN.................................... DEVICE ....................................

- ……………….. - ………………..

- ……………….. - ………………..

Dengan ketentuan bahwa Alat Kesehatan tersebut harus

mendapatkan persetujuan izin

edar sebelum diedarkan.

With the provision that such Medical Devices should obtain

the approval for the marketing license before being

marketed.


(………………………………..) (………………………………..)

NIP……………………… NIP.………………………

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

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Formulir 10 Form 10




INDONESIA



MEDICAL DEVICES OF THE MINISTRY OF

HEALTH OF THE REPUBLIC OF INDONESIA

NOMOR: ........................... NUMBER: ...........................

TENTANG REGARDING

PERUBAHAN SERTIFIKAT PRODUKSI

PERBEKALAN KESEHATAN RUMAH

TANGGA

AMENDMENT OF THE PRODUCTION

CERTIFICATE OF HOUSEHOLD PRODUCTS


DAN ALAT KESEHATAN,


PHARMACEUTICAL AND MEDICAL DEVICES,


Badan Usaha)…., (Nama

Kota)… Nomor… Tanggal…

tentang Permohonan

Perubahan pada Sertifikat

Produks Alat Kesehatan

(sebutkan perubahannya);

Reading : 1. The letter of application of

(Name of Business

Corporation)…., (Name of

City)…. Number…..

Dated….. regarding the

Application for Amendment of

the Production Certificate of

Medical Devices (mention the

amendment);


Dinas Kesehatan Provinsi….

Nomor…. Tanggal…. (bila

diperlukan);

2. Formal Report of Inspection of

the Provincial Health Office…..

Number….. Dated…. (if

needed);


Kesehatan Provinsi….

Nomor….. Tanggal……;


Provincial Health Office……

Number …… Dated……;

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 82 -

Menimbang : bahwa permohonan (Nama Badan

Usaha)……, (Nama Kota)…..

tersebut dapat disetujui, oleh karena

itu perlu menerbitkan Sertifikat

Produksi Perbekalan Kesehatan

Rumah Tangga;

Considering : that the application of (Name of

Business Corporation)….., (Name of

City) can be approved, and

therefore, it is necessary to issue the

Production Certificate for Household

Products;


Nomor




Tangga;

In view of : Regulation of the Minister of Health

Number




MEMUTUSKAN HAS DECREED

Menetapkan : To Enact

Kesatu : Memberikan Sertifikat Produksi


Tangga kepada:

First : To Provide the Production

Certificates of the Household

Products to

Nama: Name:

Perusahaan: Company:




Nama Penanggung:Jawab Teknis Name of Technical:Responsible

Person

Alamat Pabrik: Address of Manufacturer:



Kesatu temasuk Kelas…. dengan


Second : The Production Certificate of Medical

Devices, as meant in the First Dictum,

includes the Class….. with the





1. Should always be controlled by

the technical responsible


MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 83 -

pada Surat Keputusan ini. indicated in this Decree.


produksi Alat Kesehatan yang

Baik (CPAKB).

2. Applies the Good


Medical Devices.





dan Alat Kesehatan,

tembusan kepada Dinas

Kesehatan Provinsi dan

Kabupaten/Kota sesuai

lokasi.

3. Should submit the report of

production results once every

1 (one) year to the Director

General of Guidance on








laboratorium yang diakui

untuk melakukan analisa dan



produk akhir.

4. In possession of an own

laboratory or collaborate with a

recognized laboratory to carry

out the analysis and inspection

on the production materials

that are used and on the

finished products.




Nomor






terkait.


Medical Devices according to

the Regulation of the Minister

of Health Number



Medical Devices and

Household Products as well as




dikeluarkan.


for 5 (five) years effective as of the

date of issuance.

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 84 -







penetapan ini.



provision that appropriate review or

revision will be made in case of any

mistakes in this enactment.


pada tanggal……………………….. on the date of ………………………..


(………………………………..) (………………………………..)

NIP……………………… NIP.………………………


1. Dinas Kesehatan Provinsi........... 1. Provincial Health Office of ...........

2. Dinas Kesehatan Kabupaten/Kota ……. 2. District/City Health Office of ...............

3. Direktur Jenderal Perdagangan Dalam Negeri

di Jakarta.


4. Direktur Jenderal Bea dan Cukai di Jakarta. 4. Director general of Customs in Jakarta.

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

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LAMPIRAN KEPUTUSA N DIREKTUR JENDERAL




GENERAL OF GUIDANCE ON

PHARMACEUTICAL AND MEDICAL DEVICES

OF THE MINISTRY OF HEALTH

NOMOR: ............................ NUMBER: ............................

TANGGAL: ........................... DATE: ...........................


diizinkan diproduksi:


produced:

………………………………… ……………………………….

………………………………… ……………………………….

………………………………… ……………………………….


diizinkan dikemas ulang dan di uji ulang:


repacked and retested.

………………………………… ………………………………

………………………………… ………………………………

………………………………… ………………………………

Dengan ketentuan bahwa Perbekalan Kesehatan Rumah

Tangga tersebut harus mendapatkan persetujuan izin

edar sebelum diedarkan.

With the provision that such Household Products should

obtain the approval for the marketing license before

being marketed.


(………………………………..) (………………………………..)

NIP……………………… NIP..………………………

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 86 -

Formulir 11 Form 11





MEDICAL DEVICES


INDONESIA

MINISTRY OF HEALTH OF THE REPUBLIC OF

INDONESIA

NOMOR: ……………………………. NUMBER: …………………………….

TENTANG REGARDING

PENCABUTAN SERTIFIKAT PRODUKSI ALAT

KESEHATAN/PERBEKALAN KESEHATAN

RUMAH TANGGA

WITHDRAWAL OF PRODUCTION CERTIFICATE

OF MEDICAL DEVICES/HOUSEHOLD

PRODUCTS


DAN ALAT KESEHATAN,


PHARMACEUTICAL AND MEDICAL DEVICES,

Membaca : Surat Kepala Dinas Kesehatan

Provinsi (Nama Badan Usaha)……,

(Nama Kota) …… Nomor …..

Tanggal …… perihal usul

pencabutan Sertifikat Produksi Alat


Rumah Tangga atas nama ………

Reading : Letter of the Head of the Provincial

Health Office of (Name of Business

Corporation)…, (Name of City)…..

Number… Dated regarding the

proposal for withdrawal of the


Devices/Household Products in the

name of .

Menimbang : bahwa……. telah melakukan

pelanggaran-pelanggaran:

Considering : that……. has conducted the following

violations:

1. ………………………………….. 1. …………………………………..

2. ………………………………….. 2. …………………………………..

3. ………………………………….. 3. …………………………………..

4. ………………………………….. 4. …………………………………..

Mengingat : Peraturan Menteri Kesehatan Nomor


tentang Produksi Alat Kesehatan dan

In view of : Regulation of the Minister of Health

Number 1189/MENKES/PER/VIII/2010


MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 87 -


Tangga;



Menetapkan : To Enact :

Kesatu : Mencabut Keputusan Nomor tanggal

Tentang Pemberian Sertifikat

Produksi Alat Kesehatan/Perbekalan

Kesehatan Rumah Tangga kepada

First : Withdraw the Decree Number dated

Regarding the Provision of the


Devices/Household Products to

Kedua : Keputusan ini mulai berlaku sejak

tanggal ditetapkan

Second : This Decree commences effective as of

the date of enactment.


pada tanggal……………………….. on the date of ………………………..


(………………………………..) (………………………………..)

NIP……………………… NIP. ………………………


1. Menteri Kesehatan Rl. 1. Minister of Health of the Republic of Indonesia.


Jakarta.



4. Kepala Dinas Kesehatan Provinsi...... 4. Head of Provincial Health Office of ......

5. Kepala Dinas Kesehatan Kabupaten/Kota …. 5. Head of District/City Health Office of ......

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 88 -

Formulir 12 Form 12

PRODUCTION

LAPORAN PRODUKSI ALAT KESEHATAN DAN

PERBEKALAN KESEHATAN RUMAH TANGGA

REPORT OF MEDICAL DEVICES AND

HOUSEHOLD PRODUCTS

Tahun Produksi……………………… Production Year ………………………

Nama Perusahaan : ………………………. Name of Company : ……………………….

Nomor Sertifikat

Produksi

: ………………………. Number of Production

Certificate

: ……………………….

Nomor Nama

Produk

Nomor

Izin Edar

Jumlah

Produksi

Keterangan Number Name of

Product

Marketing

License

Number

Amount of

Production

Remarks

………………………………………………… …………………………………………………

(________________________________________) (________________________________________)

Direktur/ Penanggung Jawab Teknis Director/Technical Responsible Person

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 89 -

Formulir 13 Form 13

BERITA ACARA PEMUSNAHAN FORMAL REPORT OF ERADICATION OF

ALAT KESEHATAN / PERBEKALAN


MEDICAL DEVICES / HOUSEHOLD PRODUCTS

Pada hari ini ............ tanggal ............... bulan ............

tahun ......... telah dilakukan pemusnahan Alat

Kesehatan/Perbekalan Kesehatan Rumah Tangga

sebagai berikut:

On this day ............ the date of ............ month ............

year ......... the eradication of Medical

Devices /Household Products has been carried out as

follows:

No Nama Produk

Jumlah

Satuan Cara

Pemusnahan

No Name Amount of

Products

Unit Eradication

Procedure

Pada sarana produksi……..................yang berlokasi

di………………………………………………………

On the production means……......................located

at………………………………………………………………

Yang melakukan pemusnahan : Executors of eradication:

1. Pimpinan Perusahaan………………….. 1. Company Management…………………..

2. Penanggung Jawab Teknis……………. 2. Technical Responsible Person…………….

Saksi - saksi: Witnesses:

1. Nama: 1. Name:

NIP/NIK: NIP/NIK:

Jabatan: Position:

2. Nama: 2. Name:

NIP/NIK: NIP/NIK:

Jabatan:

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 90 -

…………………….,……………..200……. …………………….,……………..200…….

Yang Melakukan Pemusnahan, Executor of Eradication,

(.......................................) (.......................................)

Penanggung Jawab Teknis Technical Responsible Person

(.......................................) (.......................................)

Pimpinan Perusahaan Company Management

Saksi - Saksi: Witnesses:

1. ………………………. ……………………. 1. ………………………. …………………….

2. ………………………. ……………………. 2. ………………………. …………………….

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

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Formulir 14 Form 14

LAPORAN HASIL PRODUKSI ALAT

KESEHATAN / PERBEKALAN KESEHATAN

RUMAH TANGGA OLEH PRODUSEN

PRODUCTION REPORT OF MEDICAL DEVICES /

HOUSEHOLD PRODUCTS BY THE

MANUFACTURER

Tahun …………. Year …………….

No. Nama

Produk

Nomor

Izin Edar

Produk

Jumlah

Produksi

Daerah

Pemasaran

Keterangan No. Name of

Production

Marketing

License

Number

Amount of

Production

Marketing

Area

Remarks

Jakarta,…………………..20…………… Jakarta,…………………..20……………

(_________________________) (_________________________)

Direktur / Penanggung jawab Teknis Director / Technical Responsible Person

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

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Formulir 15 Form 15

DINAS KESEHATAN PROVINSI…………… PROVINCIAL HEALTH OFFICE OF ……………

Nomor: ………………… Number: ……………………

Lampiran: Enclosure:

Perihal: Hasil Pembinaan dan Pengawasan

Sarana Produksi Alat


Rumah Tangga

Subject: Result of Guidance and Control on the

Means of Production of Medical Devices /

Household Products

Kepada Yth. To


Alat Kesehatan

Director General of Guidance on


Kementerian Kesehatan Rl Ministry of Health of the Repubic of

Indonesia

di- in-

JAKARTA JAKARTA

Bersama ini kami sampaikan laporan

hasil pembinaan dan pengawasan sarana

produksi Alat Kesehatan/Perbekalan

Kesehatan Rumah Tangga yang

dilakukan di Provinsi…… tahun……

We herewith submit the report on the results

of guidance and control on the means of the

Medical Devices/Household Products

production carried out in the Province

of…….. in the year of ………..

Kepala Dinas Kesehatan Provinsi Head of Provincial Health Office

…………………………………………… ……………………………………………

(………………………………….) (………………………………….)

NIP …………………………………… NIP. ……………………………………

MENTERI KESEHATAN

REPUBLIK INDONESIA


INDONESIA

- 93 -

I, Anang Fahkcrudin, a sworn and authorized translator, practicing in Jakarta, do solemnly and sincerely declare that the foregoing document is a true and faithful translation from Indonesian into English of the original version.

Jakarta, December 29, 2011

LAPORAN HASIL PEMBINAAN DAN

PENGAWASAN

REPORT ON THE RESULTS OF GUIDANCE AND

CONTROL

SARANA PRODUKSI ON THE MEANS OF PRODUCTION

ALAT KESEHATAN/PERBEKALAN


OF MEDICAL DEVICES/HOUSEHOLD PRODUCTS

Tahun...................... Year......................

No

Nama

Sarana

No

Sertifikat

Produksi

Alamat

Jenis

Produksi

No Izin

Edar

Produk

Aktif/Tidak

Aktif No

Name

of

Means

Production

Certificate

Number

Address

Type of

Product

Marketing

License

Number

Active/Not Active

Kepala Head of

Dinas Kesehatan Provinsi Provincial Health Office

…………………………….. ……………………………..

(………………………………) (………………………………)

NIP………………….. NIP…………………..

MENTERI KESEHATAN MINISTER OF HEALTH OF THE...

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