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ALUR NIE IMPOR (AKL)
FORM A
FORM A1
Point Data Administrasi nomer 1, SKIP karena untuk ALKES dalam negeri
FORM A2
1. Nomor Sertifikat : S-IPAK144550001140121

2. Jenis Product :
 Alat Kesehatan Non Elektromedik Steril
 Alat Kesehatan Non Elektromedik Non Steril
3. Tanggal Kadaluwarsa : 1 Maret 2026
4. Lampiran File Sertifkat Produksi : di Folder IPAK - Sertfikat IPAK CPM (S-
IPAK144550001140121)
FORM A3
LOA belum dapet dari Premier (PP,FP,Nitrile)
FORM A4
CFS belum dapet dari Premier (PP,FP,Nitrile)
FORM A5
Premier ISO 9001 dan ISO 13485 (terlampir di folder : Dektop – Registrasi NIE - Premier
1. Nama Sertifkat : Quality System Sertificate
2. Nomor Sertifikat : 110588-2
3. Instansi Yang Mengeluarkan : KGS Certification/ Accreditation Mark are Subject to the Regulations
Applicable to Holders of KGS Sdn. Bhd
4. Tanggal dikeluarkan : 13 Maret 2019
5. Tanggal kadaluwarsa : 12 Maret 2022
6. Jenis Product : Manufacturing, Packing, and Distribution of Medical Glove
7. Lampiran File ISO 13485 dan ISO 9001 terlampir, CE on Process dimintakan ke Premier (udah dipecah
ISO 9001 dan ISO 13485)
FORM A6
1. Excecutive Summary :
PREMIER Outlook’s Latex Examination Gloves are made from Premium Quality Natural Rubber
Latex together with State-of-the-Art Technology and stringent in house quality assurance
procedures, they are made from multiples uses like medical patient examinations, operation
theaters, diagnostic procedures by dentists, and general medical procedures and laboratory
practices.
2. Riwayat Penggunaan : The products are being used in Operation Theaters, Medical Patient
Examinations, Diagnostic procedures by Dentist and Laboratory Practices.
3. Mekanisme Kerja:
Product Risk
 Contains natural rubber latex which may cuase allergic reactions in some people
 Components used in product manufacturing may cuase all allergic reaction in some
users
Please consult physician should this occur
 Safe use of the product by or on latex sensitized individuals has not been established
 Store in COOL, DRY PLACE
 Do not expose product under direct sunlight or fluorescent light
READ THE SUE INTRUCTIONS ON THE PACKAGING BEFORE USE
4. Tujuan Penggunaan : This products are excellent for use as a Biological Barrier but are not to be use
as chemical barrier
5. Formula :
KOH
Ammonium Laurate
Teric
Ammonia
STI Dispersion
ZAA Dispersion
PEG 4000
Mobilcer
Water
6. Riwayat Penggunaan : The products are being used in Operation Theaters, Medical Patient
7. Lampiran File : Terlampir di folder
FORM A7
1. Instansi yang mengeluarkan

2. Tanggal dikeluarkan : 1 April 2021
3. Jenis Produk : Latex Examination Gloves Powdered
4. Tanggal Kadaluwarsa : 1 April 2026
5. Lampiran File : terlampir di folder Premier
FORM A8
1. Lampiran File Surat Pelepasan Keagenan  Sudah dibuat tinggal di ttd Pak Robert
2. Lampiran File Surat Paten Merek dari HAKI untuk Produk OEM  Skip
FORM A9
Lampiran File Surat Pernyataan Keaslian Data  Sudah dibuat tinggal di ttd Pak Robert
Lampiran File Pakta Integritas  Sudah dibuat tinggal di ttd Pak Robert
FORM B
FORM B1- B13 (Untuk PP, PE, nitrile cek dulu ada perbedaan
atau tidak)
1. Deskripsi Uraian Alat :
Product manufactured at Premier Outlook Sdn Bhd comply to international
stadards as per USA standard ASTM D3578-00 and European standard EN455.
The products are being used in Operation Theaters, Medical Patient
2. Deskripsi dan fitur Alat Kesehatan

 Very Light in Color
 Superb Sensitivity
 Beaded Cuff for Easy Donning
 Excellent Tensile Strength/ Elasticity
 Longer Shelf Life
3. Uraian Tujuan Penggunaan

The products are being used in Operation Theaters, Medical Patient Examinations,
Diagnostic procedures by Dentist and Laboratory Practices.
4. Indikasi
Untuk melindungi tangan/ kulit selama proses pengobatan pasien.
5. Petunjuk Penggunaan (dalam bahasan Indonesia)

- Buka kemasan sarung tangan medis
- Pastikan sarung tangan medis dalam kondisi baik
- Pastikan sebelum menggunakan, tangan sudah dalam kondisi bersih/ steril
- Keluarkan sarung tangan dari kemasan
- Gunakan sarung tangan medis pada tangan kanan dan kiri
6. Kontra Indikasi
- Contains natural rubber latex which may cuase allergic reactions in some people
- Components used in product manufacturing may cuase all allergic reaction in some
users
7. Peringatan (bila ada)

- Safe use of the product by or on latex sensitized individuals has not been
established
- Store in COOL, DRY PLACE
- Do not expose product under direct sunlight or fluorescent light
8. Perhatian (bila ada)
- Safe use of the product by or on latex sensitized individuals has not been
established
- Store in COOL, DRY PLACE
- Do not expose product under direct sunlight or fluorescent light
9. Potensi Efek Yang Tidak Diinginkan : allergic reactions
10. Alternatif Terapi : ga ada

11. Nama Bahan Baku LAGI DI TANYA
 Nama Bahan Baku:
 Formula Secara Kualitatif dan Kuantitatif
 Untuk produk diagnostic dan reagensia harus menyertakan MSDS
(Material Safety Data Sheet)
12. Informasi Pabrik

Ringkasan atau rujukan atau berisi dokumentasi yang berhubungan dengan
proses produksi, termasuk pengukuran jaminan mutu, yang memadai sesuai
dengan tingkat kerumitan dan tingkat resiko alat. :
Jawaban :
Product manufactured at Premier Outlook Sdn Bhd comply to international stadards as per
USA standard ASTM D3578-00 and European standard EN455. The products are being used
in Operation Theaters, Medical Patient Examinations, Diagnostic procedures by Dentist and
Laboratory Practices
Standards and Usage

Product manufactured at Premier Outlook Sdn Bhd comply to international stadards as per
USA standard ASTM D3578-00 and European standard EN455. The products are being used
in Operation Theaters, Medical Patient Examinations, Diagnostic procedures by Dentist and
Laboratory Practices.
Quality Concepts:
The performance of product must conform to certain standard which required by certain
regulatory bodies.
In order to comply to the standard starting from receiving of raw material until delivery of
finished products so as suspect or defective materials/ products are prevented from
inadvertent installation/ use or shipment.
The conformance of the product is monitored based on series of specification standards

which consist of raw materials specs standard, inspection and testing spec standards and
also gloves specs standard.
Quality Managament System

In order to ensure that all the activities concerning the product are propely carried out
documented according to the company’s Quality plan, the activities are systematically
monitored by quality assurance personnel’s independently. The factory also adopted various
quality management standards such as ISO 9001: 2015 & ISO 13485 : 2016 and Good
Manucafturing Practice (GMP) guides from USFDA
The quality objective of the company is specified and displayed around the factory. This is to
ensure that the quality policy is to ensure that the quality policy is well received and
understood by all, personnel’s involving in the manufacturing of products.
13. Proses Produks : Lampiran File (PP terlampir)
FORM C (belum semua on process diminta ke Ms.

Fara)
C1 the functional characteristics and technical performance specifications tool
C10 the specifications and or raw material requirements / COA Raw Material
C13 Finished Product COA File and File QC Pass / Inspection Report
FORM D
FORM D1 (inner box)
1. Di Folder Premier sudah terlapir, baru yang PP

FORM D2
(penandaan pada alat, yang kek payung, angka 2
dicoret)
2. Lagi ditanya ke premier diminta untuk dipisah document nya

Jelaskan penandaan yang ada pada alat (lagi di tanya ke
premier)
FORM D3
3. Berikan dan jelaskan petunjuk penggunaan, materi pelatihan &

petunjuk pemasangan serta pemeliharaan (Dalam Bahasa
Indonesia)
FORM D4
4. Berikan kode produksi dan artinya  Done

FORM E
FORM E1
1. Berikan prosedur yang digunakan dan sistem pencatatan, penanganan komplain,

Laporan Kejadian Efek yang tidak diinginkan dan Prosedur Recall (Wajib untuk
kelas 2 dan kelas 3)
 Keterangan
 Lampiran File
(Semua product belum dikirim, sedang dimintakan, sudah ditanyakan contoh nya)

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ALUR NIE IMPOR (AKL)

1. Nomor Sertifikat : S-IPAK144550001140121

LOA belum dapet dari Premier (PP,FP,Nitrile)

CFS belum dapet dari Premier (PP,FP,Nitrile)

Please consult physician should this occur

READ THE SUE INTRUCTIONS ON THE PACKAGING BEFORE USE

1. Instansi yang mengeluarkan

2. Deskripsi dan fitur Alat Kesehatan

3. Uraian Tujuan Penggunaan

5. Petunjuk Penggunaan (dalam bahasan Indonesia)

7. Peringatan (bila ada)

9. Potensi Efek Yang Tidak Diinginkan : allergic reactions

10. Alternatif Terapi : ga ada

12. Informasi Pabrik

Standards and Usage

The conformance of the product is monitored based on series of specification standards

Quality Managament System

13. Proses Produks : Lampiran File (PP terlampir)

FORM C (belum semua on process diminta ke Ms.

1. Di Folder Premier sudah terlapir, baru yang PP

2. Lagi ditanya ke premier diminta untuk dipisah document nya

3. Berikan dan jelaskan petunjuk penggunaan, materi pelatihan &

4. Berikan kode produksi dan artinya  Done

1. Berikan prosedur yang digunakan dan sistem pencatatan, penanganan komplain,

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