The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
ABSTRACT- Populus deltoides is the exotic species of poplar introduced in India in late 50s and has been grown significantly in North– western states. It is one of the most important commercial tree planted in agrosilvicutural system adopted by farmers of the region. Meanwhile, it is prone to number of biotic and abiotic agents, which affects the plantations and thus depreciates its quality. Hence, to prevent the loss and manage the diseases, apart from fungicidal use biocontrol strategy has been adopted. In the present study fifteen isolates of Alternaria alternata has been tested against Trichoderma harzianum and Trichoderma viride. Both the antagonists were at par in suppressing the fungal growth and did not achieve the significant level of inhibition. T. harzianum could be shown as better biocontrol agent than the latter owing to the percent growth inhibition shown by the isolates.
Key-words- Populus deltoides, Alternaria alternata, Biocontrol, Growth suppression
Speed your time to market by following the step-by-step instructions.
You'll learn the steps to success for product testing by a certification agency (like UL, TÜV, BSI, Intertek, etc.) to the IEC 60601-1 series of standards on medical electrical equipment and systems.
See the mistakes others have made that have slowed down their certification process (and how you can avoid them).
Take proactive steps so your product doesn’t need to get redesigned after testing starts.
Specifically, you will learn:
-The scope of IEC 60601-1 standards & if they apply to your product.
-What you need to know to classify your products to the IEC 60601-1 series.
-What is an isolation diagram and how does that help me with my design?
-Determine the applicable tests for your device.
-What are the marking and labeling requirements for the device?
-Know your critical components.
-What pre-tests to run and what’s not worth testing?
-Resources to help with this process and ways to reduce the paperwork off your backs.
Watch the presentation here: https://www.greenlight.guru/webinar/iec-60601-1
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
ABSTRACT- Populus deltoides is the exotic species of poplar introduced in India in late 50s and has been grown significantly in North– western states. It is one of the most important commercial tree planted in agrosilvicutural system adopted by farmers of the region. Meanwhile, it is prone to number of biotic and abiotic agents, which affects the plantations and thus depreciates its quality. Hence, to prevent the loss and manage the diseases, apart from fungicidal use biocontrol strategy has been adopted. In the present study fifteen isolates of Alternaria alternata has been tested against Trichoderma harzianum and Trichoderma viride. Both the antagonists were at par in suppressing the fungal growth and did not achieve the significant level of inhibition. T. harzianum could be shown as better biocontrol agent than the latter owing to the percent growth inhibition shown by the isolates.
Key-words- Populus deltoides, Alternaria alternata, Biocontrol, Growth suppression
Speed your time to market by following the step-by-step instructions.
You'll learn the steps to success for product testing by a certification agency (like UL, TÜV, BSI, Intertek, etc.) to the IEC 60601-1 series of standards on medical electrical equipment and systems.
See the mistakes others have made that have slowed down their certification process (and how you can avoid them).
Take proactive steps so your product doesn’t need to get redesigned after testing starts.
Specifically, you will learn:
-The scope of IEC 60601-1 standards & if they apply to your product.
-What you need to know to classify your products to the IEC 60601-1 series.
-What is an isolation diagram and how does that help me with my design?
-Determine the applicable tests for your device.
-What are the marking and labeling requirements for the device?
-Know your critical components.
-What pre-tests to run and what’s not worth testing?
-Resources to help with this process and ways to reduce the paperwork off your backs.
Watch the presentation here: https://www.greenlight.guru/webinar/iec-60601-1
The UDI system was created, developed and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement. The Regulations allow for random inspections of producers’ facilities after devices have been placed on the market.
Accelerating Medical Device Development While Improving ComplianceAaron Joseph
Medical device companies can take advantage of lean and agile methods for speeding up hardware and software development if they understand how to adapt their quality system to support the new methods and ensure regulatory compliance.
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
The Command Center - one screen to rule them allPaul Grant
A presentation from the Advancing Data Analytics conference in Canberra on 25th July 2018.
- The business case;
- Cross-functional data integration;
- Guiding principles;
- Command and control: actionable insights to inform operational efficiency
Cybersecurity and Software Updates in Medical Devices.pdfICS
Justin is a Senior Consulting Engineer and Qt Certified Instructor at Integrated Computer Solutions, Inc. (ICS). He has taught Qt and Qt Quick/QML material for both public and on-site courses for many years. He has also written and conducted seminars on Object-Oriented GUI Design techniques. Justin earned his bachelor’s degree in Computer Engineering Technology from Northeastern University.
The UDI system was created, developed and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement. The Regulations allow for random inspections of producers’ facilities after devices have been placed on the market.
Accelerating Medical Device Development While Improving ComplianceAaron Joseph
Medical device companies can take advantage of lean and agile methods for speeding up hardware and software development if they understand how to adapt their quality system to support the new methods and ensure regulatory compliance.
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
The Command Center - one screen to rule them allPaul Grant
A presentation from the Advancing Data Analytics conference in Canberra on 25th July 2018.
- The business case;
- Cross-functional data integration;
- Guiding principles;
- Command and control: actionable insights to inform operational efficiency
Cybersecurity and Software Updates in Medical Devices.pdfICS
Justin is a Senior Consulting Engineer and Qt Certified Instructor at Integrated Computer Solutions, Inc. (ICS). He has taught Qt and Qt Quick/QML material for both public and on-site courses for many years. He has also written and conducted seminars on Object-Oriented GUI Design techniques. Justin earned his bachelor’s degree in Computer Engineering Technology from Northeastern University.
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1. Profil Pemateri
Agus Staf Hartanto
Ketua GAKESLAB INDONESIA
Provinsi Jawa Timur
2022-2026
Riwayat Pendidikan
Riwayat Pekerjaan
Riwayat Organisasi di Gakeslab
1996-2007 Regional Manager PT Bersaudara Wilayah Indonesia
Timur
2007-2008 Regional Manager PT Global Systech Medika Wilayah
Jawa Timur dsk
2008-Sekarang Direktur PT Global Surya Medika
1991 Ilmu Hubungan Internasional UGM Yogyakarta
1995 Magister Manajemen Sekolah Tinggi Manajemen
Labora Jakarta
1999/2000 Magister Manajemen Universitas Hasanuddin
Makassar
2013-2017 Sekretaris Gakeslab Indonesia Provinsi Jawa Timur
2017-2021 Ketua Gakeslab Indonesia Provinsi Jawa Timur
2022-Sekarang Ketua Gakeslab Indonesia Provinsi Jawa Timur
+62 812 3322 5566
agushartanto@globalsurya.co.id
Tempat / Tanggal Lahir
Klaten, 28 Agustus 1966
2. Perkumpulan Organisasi Perusahaan Alat-Alat
Kesehatan dan Laboratorium (GAKESLAB) Indonesia
2
Aspek Pemenuhan
Cara Distribusi Alat
Kesehatan yang Baik
(CDAKB)
Pertemuan Koordinasi Sertifikasi CDAKB bagi Sarana
Cabang Distribusi Alkes di Provinsi Jawa Timur
Surabaya, 22 November 2022
Agus Staf Hartanto
Ketua GAKESLAB Indonesia
Provinsi Jawa Timur
1
4. Peranan Distributor Alkes dalam Rantai
Pasok Alkes
Distribusi Produk dan Penerapan CDAKB
Aspek Pemenuhan CDAKB
3
5. Peranan Distributor Alkes dalam Rantai
Pasok Alkes
Distribusi Produk dan Penerapan CDAKB
Aspek Pemenuhan CDAKB
4
6. Rantai Pasok Alkes
IMPORT
Setelah Produk Tiba
di Pelanggan
Sebelum Produk Tiba di Pelanggan
PRE MARKET POST MARKET
COMMERCIAL &
DISTRIBUTION
5
7. 7
Distribusi Alat Kesehatan di Indonesia
Sekali pakai : jarum suntik,
benang bedah, dll
Peralatan kecil : pisau &
gunting bedah
Peralatan besar : MRI, X-
Ray, CT-Scan, USG, dll
Diagnostik : alat ukur gula
darah, uji kehamilan, dll
Perawatan : band aid,
perban, popok dewasa,
pembalut wanita, dll.
Diagnostik :
sphygmomanometer,
stetoskop, dll.
Perawatan: peralatan
perawatan gigi, dll.
Target Distribusi Berpengaruh kepada Proses Distribusi & Pengawasan
Fasilitas Kesehatan Masyarakat Umum Petugas Kesehatan
Alat Kesehatan
6
8. Peranan Gakeslab Indonesia dalam
Pembinaan & Pengawasan Alkes
Memberikan berbagai pelatihan untuk Produsen dan Distributor (Pelatihan
PJT Produsen / Distributor, CDAKB, CPAKB, Pengelolaan Usaha, dll.),
termasuk memberikan sarana percontohan (CDAKB / CPAKB) dan
Coaching Clinic sertifikasi (CDAKB / CPAKB)
Mengadakan Business Matching antara Produsen dan Distributor
(diadakan secara khusus atau saat pameran), termasuk memberikan akses
pendanaan
Memberikan advokasi terkait peraturan atau praktek lapangan yang tidak
konsisten yang merugikan Produsen dan Distributor
Memberikan Pelatihan Kode Etik kepada anggota Gakeslab Indonesia
(Produsen / Distributor) agar kegiatan usaha berjalan lebih langgeng dan
lancer
Memberikan teguran dan sanksi kepada anggota yang melanggar Kode
Etik, termasuk yang terkait dengan kewajiban yang menjamin K4 produk
Memberikan edukasi kepada masyarakat melalui program EMAS (Edukasi
Masyarakat) dan Rumah Etik di Viga TV 7
9. Peranan Distributor Alkes dalam Rantai
Pasok Alkes
Distribusi Produk dan Penerapan CDAKB
Aspek Pemenuhan CDAKB
8
11. Ketentuan UU No. 36 Tahun 2009 tentang
Kesehatan (Distributor Alat Kesehatan)
Produsen Harus Menjalankan CPAKB
(Permenkes No. 20 Tahun 2017)
Distributor Harus Menjalankan CDAKB
(Permenkes No. 4 Tahun 2014)
Produk Harus Memiliki Nomor Izin Edar
(Permenkes No 62 Tahun 2017)
10
12. 12
Masalah terkait Jalur Distribusi
Langkah awal menghindari masalah K4 :
Membeli produk ber-NIE dari Distributor yang
memiliki SDAK / IDAK dan menjalankan CDAKB
No Penyebab Dampak (antara lain)
1 Distribusi ditangani langsung oleh Produsen
Pengiriman dan layanan purna jual terhambat,
khususnya di daerah yang jauh dari Produsen
2
Tidak ada kolaborasi yang baik antara Produsen &
Distributor
Keluhan pelanggan tidak tersampaikan kepada
Produsen secara cepat
3
Produsen dan/atau Distributor tidak memahami Cara
Produksi Alkes yang Baik (CPAKB) dan/atau Cara
Distribusi Alkes yang Baik (CDAKB)
Produsen kurang bertanggung jawab (lepas tangan)
ketika ada masalah, ketiadaan data terkait
ketelusuran produk
4
Pembeli membeli produk yang tidak memiliki Nomor
Izin Edar Kemenkes (AKD/AKL)
Distributor tidak menyimpan dan mengirim barang
sesuai kaidah CDAKB
5
Pembeli tidak mau membeli produk dari Distributor
berizin (pemilik SDAK / IDAK) yang telah
menerapkan CDAKB
Pembeli tidak mendapat jaminan dan/atau layanan
purna jual yang baik saat mendapatkan produk yang
bermasalah
11
K4 (*) :
Keamanan
Kualitas
Kinerja
Ketersediaan
13. Peranan Distributor dalam Rantai Pasok Alkes
Menyalurkan Produk kepada
Pengguna (Fasilatas Kesehatan,
Masyarakat Umum, Petugas
Kesehatan) dengan Menjamin
Keamanan, Kualitas, Kinerja, dan
Ketersediaan
Kompetensi :
Distributor Bukan “Makelar” Melainkan
Penjamin K4 yang Kompeten
Amanat UU Kesehatan No. 36/2009 pasal 196 :
Peranan :
1 Cara Distribusi Alkes yang Baik
2 Peraturan Alkes
3 Pendaftaran Izin Fasilitas & Nomor Izin Edar Produk
4 Pengetahuan Produk & Prosedur
5 Pembuatan Perkiraan Kebutuhan (Forecast)
6 Pengetahuan Kondisi Lapangan
7 Ketersediaan Produk
8 Purna Jual
12
14. 14
Kegiatan Distributor Alkes
(Harus Sesuai Kaidah-kaidah CDAKB)
Kegiatan-kegiatan :
Menyimpan Produk Sesuai Kondisi yang Dibutuhkan
Mengirim Produk dengan Standar yang Tepat agar
Tidak Rusak dalam Perjalanan
Instalasi Produk (terutama Alat Elektromedis)
Melatih Pelanggan Sebelum & Sesudah Pembelian
Komunikasi dengan Pelanggan
Menangani Keluhan Pelanggan
Melakukan Tindakan Perbaikan Lapangan (Termasuk
Menarik Produk apabila Perlu)
Pemeliharaan Produk (terutama Alat Elektromedis)
13
15. Peranan Distributor Alkes dalam Rantai
Pasok Alkes
Distribusi Produk dan Penerapan CDAKB
Aspek Pemenuhan CDAKB
14
16. Cara Distribusi Alat Kesehatan yang Baik (CDAKB)
Definisi CDAKB (Permenkes No. 4 Tahun 2014 Pasal 1) : Pedoman
yang digunakan dalam rangkaian kegiatan distribusi dan
pengendalian mutu yang bertujuan untuk menjamin agar produk alat
kesehatan yang didistribusikan memenuhi persyaratan yang
ditetapkan sesuai penggunaan.
Setiap PAK dan Cabang PAK wajib menerapkan CDAKB dalam
melaksanakan kegiatan distribusi disesuaikan dengan kategori
produk yang disalurkan.
15
17. 7
Pengaturan Perizinan Berusaha (PB) Berbasis Risiko
PB KBLI (2020) Risiko Perizinan Kewenangan
Distributor Alkes 46691 Tinggi NIB + Izin + CDAKB Menteri
Cabang Distributor
Alkes
46691 Menengah Tinggi NIB + Sertifikat
Standar + CDAKB
Gubernur
PB UMKU Kewenangan
Sertifikat CDAKB (untuk Distributor Alkes) Menteri
Sertifikat CDAKB (untuk Cabang Distributor Alkes) Gubernur
Pengaturan Perizinan Berusaha untuk Menunjang Kegiatan Usaha
(PB UMKU) Berbasis Risiko
16
18. 18
Klasifikasi
/ Kategori
Alkes
Pengiriman
Penyimpanan
Pemakaian
Purna Jual
Klasifikasi dan Kategori Alkes
Mempengaruhi Distribusi Alkes
KLASIFIKASI - RESIKO PRODUK
Kelas A
Kelas B
Kelas C
Kelas D
KATEGORI KELOMPOK ALKES
Elektromedis Radiasi
Elektromedis Non Radiasi
Non Elektromedis Steril
Non Elektromedis Non Steril
Diagnostik & Reagensia (DIV)
1. Cara Pengawasan Alkes Harus Disesuaikan dengan Resiko Distribusi Alkes
2. Kemampuan & Fasilitas Distributor Harus Sesuai dengan Resiko Produk
yang Diedarkan
17
19. 9
1. Sistem Manajemen Mutu
2. Pengelolaan Sumber Daya
3. Bangunan & Fasilitas
4. Penyimpanan & Penanganan Persediaan
5. Mampu Telusur Produk
6. Penanganan Keluhan
7. Tindakan Perbaikan Keamanaan di Lapangan
8. Retur Alat Kesehatan
9. Pemusnahan Alat Kesehatan
10. Alat Kesehatan Ilegal dan Tidak Memenuhi Syarat
11. Audit Internal
12. Kajian Manajemen
13. Aktivitas Pihak Ketiga
13 Aspek CDAKB
18
21. Penerapan CDAKB (Umum)
CDAKB
Umum
Prosedur/
sistem
Fasilitas
Pelaksanaan
Khusus
Elektromedis
Radiasi
Non radiasi
Non
Elektromedis
Steril
Non steril
Diagnostik In
Vitro
1 Sistem Manajemen Mutu
2 Pengelolaan Sumber Daya
3 Bangunan & Fasilitas
4 Penyimpanan & Penanganan
Persediaan
5 Mampu Telusur Produk
6 Penanganan Keluhan
7 Tindakan Perbaikan Keamanaan di
Lapangan
8 Retur Alat Kesehatan
9 Pemusnahan Alat Kesehatan
10 Alat Kesehatan Ilegal dan Tidak
Memenuhi Syarat
11 Audit Internal
12 Kajian Manajemen
13 Aktivitas Pihak Ketiga
13 Aspek CDAKB :
20
22. Infrastruktur CDKAB
Fasilitas
Memadai ?
Sarana
Prasarana
Memadai ?
Ukuran
Tata Ruang
Pemeliharaan
Terlatih
Taat pada prosedur
Sarana Sesuai dengan Aktifitas
Sarana Terpelihara
Ada Prosedur Kerja
Prosedur Dilaksanakan
Ada Pencatatan
Pengetahuan tentang
Resiko pada Produk dan
Pengguna / Konsumen
Produk yang
Didistribusikan
Petugas
Tersedia &
Terlatih ?
Proses
Memadai ?
21
24. 24
CDAKB
Umum
Prosedur/
sistem
Fasilitas
Pelaksanaan
Khusus
Elektromedis
Radiasi
Non
radiasi
Non
Elektromedis
Steril
Non steril
Diagnostik In
Vitro
Penerapan CDAKB
(Elektromedis)
Pelatihan dan Sertifikasi Karyawan & Pelanggan
Manajemen Alat (Unit untuk Dijual, Alat untuk Demo,
Alat untuk Pengganti)
Ketersediaan Unit, Asesoris, dan Suku Cadang
Pemeliharaan & Perbaikan (Catatan & Pelaksanaan)
Kemampuan Karyawan & Pengawas
Pelaksanaan Pengawasan (Khususnya Radiasi)
Kalibrasi
Kontrak dengan Penyedia Pemeliharaan & Prinsipal
Masa Jangka Pendek
Masa Jangka Panjang
Aspek Keamanan : Catatan KTD dan Keluhan
Pelanggan
Pelatihan & Kualifikasi Pengguna
Pemantauan Pemakaian Alat di Fasilitas Kesehatan
Implementasi
23
25. Penerapan CDAKB
(Non Elektromedis)
CDAKB
Umum
Prosedur/
sistem
Fasilitas
Pelaksanaan
Khusus
Elektromedis
Radiasi
Non
radiasi
Non
Elektromedis
Steril
Non steril
Diagnostik In
Vitro
Catatan :
Standar penyaluran Alat Non-Elektromedis yang digunakan untuk melengkapi Alat
Elektromedis, penanganannya merujuk kepada standar penyaluran Alat Elektromedis
Ketersediaan produk
Pengiriman produk sesuai FIFO/FEFO
Ketepatan tata cara penyaluran memastikan
hanya pengguna yang berhak yang akan
mendapatkan produk
Proses penyimpanan & penanganan, sampai ke
tingkat eceran (utk produk konsumen) & faskes
Keterlacakan produk
Kejelasan instruksi penggunaan
Pelatihan & kualifikasi kepada pengguna – di mana
perlu
Penanganan produk yang rusak
Penanganan keluhan pelanggan
Implementasi
24
26. Penerapan CDAKB
(Non Elektromedis- Steril)
CDAKB
Umum
Prosedur/
Sistem
Fasilitas
Pelaksanaan
Khusus
Elektromedis
Radiasi
Non
radiasi
Non
Elektromedis
Steril
Non steril
Diagnostik In
Vitro
Catatan :
Persyaratan ini merupakan persyaratan tambahan dari persyaratan Non-
Elektromedis secara umum. Persyaratan umum / utama tetap harus dipenuhi)
Implementasi
Pemahaman tentang Proses Sterilisasi Produk
akan Berdampak pada Penyimpanan &
Penggunaan
Pelatihan & Pengawasan tentang Penempatan
dan Penanganan Produk di Fasilitas Kesehatan
agar Sterilitas Produk Terjaga
25
27. 27
CDAKB
Umum
Prosedur/
sistem
Fasilitas
Pelaksanaan
Khusus
Elektromedis
Radiasi
Non radiasi
Non
Elektromedis
Steril
Non steril
Diagnostik In
Vitro
Penerapan CDAKB
(Diagnostik In Vitro)
Implementasi
Kejelasan terkait Instruksi Penggunaan
Ketersediaan Kit & Reagensia, terutama
untuk Unit Alat “Close System”
Pengiriman Produk Sesuai FIFO/FEFO
Proses Penyimpanan & Penanganan untuk
Menjaga Kestabilan Suhu
Ketepatan Tata Cara Penyaluran untuk
Memastikan Hanya Pengguna yang Berhak
yang akan Mendapatkan Produk
Harus Ada Edukasi terkait Proses
Penyimpanan di Tingkat Eceran (untuk
Produk Konsumen) & di Fasilitas Kesehatan
Ketelusuran Produk
Pelatihan & Kualifikasi jika Diperlukan
26
28. Message
Pelanggan Harus Membeli Produk Ber-
Nomor Izin Edar dari Distributor SDAK /
IDAK yang Menjalankan CDAKB
Apabila Ada Masalah, Pelanggan Harus
Melaporkan Secara Aktif Melalui Aplikasi
Mobile Alkes Farmalkes Kemenkes
Tindakan Tegas di Lapangan (Teguran hingga
Pencabutan Izin / Pidana) bagi Pelanggan
maupun Pengusaha yang Melanggar
Ketentuan UU No 36 Tahun 2009 tentang
Peredaran Produk Alkes agar Ada Efek Jera
Syarat Efektifitas Penerapan CDAKB
Anggota GAKESLAB Indonesia Provinsi Jawa Timur Siap
Menjadi Mitra Distribusi Alkes Terpercaya di Jawa Timur
27
30. GAKESLAB INDONESIA
Kantor Pusat :
Komplek Perkantoran Graha Mas Pemuda,
Blok AD/23
Jl. Pemuda, Rawamangun
Jakarta Timur, 13220
Telp : +62-21-2248-0259
Website : www.gakeslabindonesia.id
GAKESLAB JAWA TIMUR
Kantor :
Jln. Gayungsari Barat X No.10 Surabaya 60235
Telp : +623182518566
Email : gakeslabjatim@gmail.com
28