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Keputusan Direktur Jenderal Sumber Daya Dan Perangkat Pos Dan Informatika

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KEMENTERIAN KOMUNIKASI DAN INFORMATIKA REPUBLIK INDONESIA KEPUTUSAN DIREKTUR JENDERAL SUMBER DAYA DAN PERANGKAT POS DAN INFORMATIKA NOMOR 159 TAHUN 2019 TENTANG PENGAKUAN BALAI UJI LUAR NEGERI UNTUK PERANGKAT TELEKOMUNIKASI SELAIN PESAWAT TELEPON SELULER, KOMPUTER GENGGAM, DAN KOMPUTER TABLET DIREKTUR JENDERAL SUMBER DAYA DAN PERANGKAT POS DAN INFORMATIKA Menimbang a. bahwa salah satu persyaratan dalam permohonan sertifikasi alat dan/a tau perangkat telekomunikasi adalah Laporan Hasil Uji (LHU) I Test Report; b. bahwa dalam Peraturan Menteri Komunikasi dan lnformatika Nomor 16 Tahun 2018 tentang Ketentuan Operasional Sertifikasi Alat dan/a tau Perangkat Telekomunikasi salah satu ketentuannya mengatur mengenai Pasal 26 ayat (2) bahwa Balai Uji Luar Negeri ditetapkan oleh Direktur Jenderal; c. bahwa berdasarkan pertimbangan sebagaimana dimaksud dalam huruf a, dan huruf b perlu menetapkan Keputusan Direktur Jenderal Sumber Daya dan Perangkat Pos dan Informatika tentang Pengakuan Balai Uji Luar Negeri untuk perangkat telekomunikasi Selain Pesawat Telepon Seluler, Komputer Genggam, dan Komputer Tablet; Mengingat 1. Undang-Undang Nomor 36 Tahun 1999 tentang Telekomunikasi (Lembaran Negara Tahun 1999 Nomor 154, Tambahan Lembaran Negara Nomor 3881); - 2 - 2. Peraturan Pemerintah Nomor 52 Tahun 2000 tentang Penyelenggaraan Telekomunikasi (Lembaran Negara Tahun 2000 Nomor 107, Tambahan Lembaran Negara Nomor 3980); 3. Peraturan Presiden Nomor 54 Tahun 2015 tentang Kementerian Komunikasi dan Informatika (Lembaran Negara Republik Indonesia Tahun 2015 Nomor 96); 4. Peraturan Menteri Komunikasi dan Informatika Nomor 15 Tahun 2012 tentang Petunjuk Pelaksanaan Penetapan Balai Uji Dalam Negeri (Berita Negara Republik Indonesia Tahun 2012 Nomor 577); 5. Peraturan Menteri Komunikasi dan Informatika Nomor 16 Tahun 2012 tentang Petunjuk Pelaksanaan Pengakuan Balai Uji Negara Asing (Berita Negara Republik Indonesia Tahun 2012 Nomor 578); 6. Peraturan Menteri Komunikasi dan Informatika Nomor 6 Tahun 2018 tentang Organisasi dan Tata Kerja Kementerian Komunikasi dan Informatika (Berita Negara Republik Indonesia Tahun 2018 Nomor 109); 7. Peraturan Menteri Komunikasi dan Informatika Nomor 7 tahun 2018 tentang Pelayanan Perizinan Berusaha Terintegrasi Secara Elektronik Bidang Komunikasi dan Informatika (Berita Negara Republik Indonesia Tahun 2018 Nomor 1041); 8. Peraturan Menteri Komunikasi dan Informatika Nomor 16 tahun 2018 tentang Ketentuan Operasional Sertifikasi Alat dan/ atau Perangkat Telekomunikasi (Berita Negara Republik Indonesia Tahun 2018 Nomor 1801); 9. Petikan Keputusan Presiden Nomor 118/TPA/2016 tentang Pemberhentian dan Pengangkatan dari dan dalam Jabatan Pimpinan Tinggi Madya di Lingkungan Kementerian Komunikasi dan Informatika. - 3 - MEMUTUSKAN: Menetapkan KEPUTUSAN DIREKTUR JENDERAL SUMBER DAYA DAN PERANGKAT POS DAN INFORMATIKA TENTANG PENGAKUAN BALAI UJI LUAR NEGERI UNTUK PERANGKAT TELEKOMUNIKASI SELAIN PESAWAT TELEPON SELULER, KOMPUTER GENGGAM, DAN KOMPUTER TABLET. KESATU Menetapkan Balai Uji Luar Negeri sebagaimana tercantum dalam Lampiran yang merupakan bagian tidak terpisahkan dari Keputusan Direktur Jenderal ini sebagai Balai Uji yang diakui untuk menerbitkan Laporan Hasil Uji atau Test Report untuk Perangkat Telekomunikasi selain Pesawat Telepon Seluler, Komputer Genggam, dan Komputer Tablet. KEDUA Laporan Hasil Uji atau Test Report yang diterbitkan oleh Balai Uji Luar Negeri yang telah diakui sebagaimana dimaksud dalam Diktum KESATU dapat digunakan sebagai pemenuhan salah satu persyaratan dalam permohonan Sertifikasi Alat dan/ atau Perangkat Telekomunikasi selain Pesawat Telepon Seluler, Komputer Genggam, dan Komputer Tablet. KETIGA Pengakuan Balai Uji Luar Negeri sebagaimana dimaksud dalam Diktum KESATU didasarkan pada kriteria: a. memiliki kemampuan melakukan pengujian alat dan/ atau perangkat telekomunikasi sesuai persyaratan teknis yang ditetapkan di Indonesia atau yang setara; b. terakreditasi sebagai balai uji berdasarkan ISO/IEC 17025 yang terakreditasi oleh Lembaga Akreditasi penandatangan Asia Pacific Accreditation Cooperation - Mutual Recognition Agreement (APAC-MRA), International Laboratory Accreditation Cooperation-Mutual Recognition Arrangement (ILAC-MRA); dan c. memiliki paling sedikit 2 (dua) bukti akreditasi dan/atau pengakuan dari lembaga internasional atau regulator telekomunikasi negara lain. - 4 - KEEMPAT Pengakuan Balai Uji Luar Negeri sebagaimana dimaksud dalam Diktum KESATU berlaku selama 6 (enam) bulan. KELIMA Keputusan ini mulai berlaku 10 (sepuluh) hari sejak tanggal ditetapkan. Ditetapkan di Jakarta pada tanggal 12 Juli 2019 DIREKTUR JENDERAL SUMBER DAYA DAN PERANGKAT S DAN INFORMATIKA, ISMAIL LAMPIRAN KEPUTUSAN DIREKTUR JENDERAL SUMBER DAYA DAN PERANGKAT POS DAN INFORMATIKA NOMOR 159 TAHUN 2019 TENTANG PENGAKUAN BALAI UJI LUAR NEGERI UNTUK PERANGKAT TELEKOMUNIKASI SELAIN PESAWAT TELEPON SELULER, KOMPUTER GENGGAM, DAN KOMPUTER TABLET DAFTAR BALAI UJI LUAR NEGERI YANG DIAKUI UNTUK PERANGKAT TELEKOMUNIKASI SELAIN PESAWAT TELEPON SELULER, KOMPUTER GENGGAM, DAN KOMPUTER TABLET NAMA BALAI UJI LUAR No. LOKASI NEGERI 1 7Layers GmbH Ratingen, Germany 2 7layers KR Suwon, South Korea 3 7Layers, Inc., Irvine Irvine, USA 4 7Layers, Inc., Sunnyvale Sunnyvale, USA Taoyuan, Taiwan 5 A Test Lab Techno CorQ. ADR Testing Service 6 Illinois, Chicago, USA Motorola Mobility LLC 7 AT4 wireless, Inc. Herndon, USA No.6 Ke Feng Road B52, Audix Technology Co., Ltd 8 Shenzen Science&Industry park, (Shenzhen) Nanshan, Shenzen, China No.1289 Jiang Xing East Audix Technology Co., Ltd Road.,The Eastern Part of 9 (Wujiang) Wujian Economic Development. Jiangsu, China No. 53-11, Dingfu, Linkou Dist., Audix Technology 10 New Taipei City,244, Taiwan Corporation (R.O.C) Bay Area Compliance 11 Sunnyvale, California, USA Laboratories Corp. 12 BluFlux, LLC Louisville, USA No. 29, Jintang Roang, Shanghai 13 BTL Inc ( Shanghai) 201210, China No.3 Jinshagang 1st Road 14 BTL Inc (Guangdong) ShiXia, Dalang Town, Guangdong, China No. 66/68-1, Ln. 169, Sec. 15 BTL Inc (Taipei) 2, Datong Rd., Xizhi Dist.New Taipei City 221, Taiwan No 81-1 , Lu Liao Keng , 9th 16 Burau Veritas (Hsinchu) Ling, Wulung Tsuen, Chiunglin Hsiang, Hsinchu Hsien 3017 No. 47-2 14th Ling, Chiapau 17 Burau Veritas (Taipei) Tsuen, Linkou Hsiang 244, Taipei Hsien Bureau Veritas ?Layers 18 Communication Technology Shenzhen, China Co Ltd Bureau Veritas ADT 19 Taoyuan, Taiwan (Taoyuan) 20 Bureau Veritas ADT (Xindian) New Taipei City, Taiwan No.49, Ln. 206, Wende Rd., Bureau Veritas CPS (Hong 21 Shangshan Tsuen, Chiung Lin Kong) Ltd, (HsinChu) Hsiang, Hsin Chu Hsien, Taiwan No. 47-2, 14th Ling, Chia Pau Bureau Veritas CPS (Hong 22 Vii., Lin Kou Dist., New Taipei Kong) Ltd, (LinKou) City, Taiwan No.19, Hwa Ya 2nd Rd., Wen Bureau Veritas CPS (Hong 23 Hwa Vil., Kwei Shan Dist., Kong) Ltd, (Taoyuan) Taoyuan City, Taiwan; Bureau Veritas CPS Korea 24 Suwon, South Korea Ltd E-2, No.1, Li Hsin 1st Road, Bureau Veritas CPS Ltd., 25 Hsinchu Science Park, Hsinchu, (Hsinchu) Taiwan 1/F, No.55, Lane 260, RenOai Bureau Veritas CPS Ltd., Road(Section 3), Luzhu 26 (Taoyuan) Township, Taoyuan County, Taiwan R.O.C. No.34 Chenwulu Section, Bureau Veritas Shenzen Co., 27 Guantai Road, Houjie Town, Ltd, (Dongguan) Guangdong 523942, China No. 139 Wugong Rd. Wugu 28 CCS Co. Ltd, Taiwan Township, Taipei County 24891, Taiwan CDTL N oida, TechMahindra 29 Noida, India Ltd No. 11, Lane 41, Fushuen St, Central Research Technology 30 Jungshan Chiu, Taipei, Taiwan, Co. 104, R.O.C. lF., No.lO, Taida Rd., Cerpass Technology Co., Ltd 31 ChanganAn, Dongguan City, (Dongguan) Guangdong 523850, China No.66,Tangzhuang Road, Suzhou Cerpass Technology Co., Ltd 32 Industrial Park, Jiangsu 215006, (Suzhou) China No.10, Ln. 2, Lianfu St., Luzhu Cerpass Technology 33 Dist., Taoyuan City 33848, Corporation Taiwan Cetecom ICT Services GmbH 34 Essen, Germany (Essen) 35 Cetecom ICT Services GmbH Untertuerkheimer Strasse 6-10 (Saarbriicken) 66117 Saarbriicken, Germany 36 Cetecom Inc. Mi!£itas, USA 37 Cetecom Limited Anyang, Korea CGC Mobile 38 Communications Laboratory Taoyuan, Taiwan (Taoyuan) CGC Mobile 39 Communications Laboratory Xindian City, Taiwan (Xindian) China Mobile Group Device 40 Beijing, China Company Limited Laboratory Cisco Systems (China) 41 Research and Development Shanghai, China Co., Ltd Cisco Systems (China) 42 Research and Development Shanghai, China Co., Ltd 170 West Tasman Drive, San 43 Cisco Systems, Inc. Jose, CA 95134-1706 22116 23rd Dr SE, Bothell, WA 44 CKC Laboratories, Inc. 98021, USA 45 Compliance Certification No. 11 Wugong 6th Rd., Wugu, Services Inc. New Taipei City Dist., Taiwan 46 Core Compliance Testing 79 River Rd, Hudson, NH, USA Services 03051 CSA Group- Taiwan No.26, Fuxing 3rd Road, Canadian Standards 47 Guishan District, Taoyuan City Association (Far East 333, Taiwan Operations) Ltd. 34 Bunsen, Irvine, California, 48 CSA Group (Califomia) USA 49 CSA Group (Guangzhou) Guangzhou, China Unit 110 - 13799 Commerce CSA Group Testing & 50 Pkwy, Richmond, British Certification Inc (Richmond) Columbia, Canada 51 CSA Group Testing & 178 Rexdale Blvd., Toronto, Certification Inc (Toronto) Ontario, Canada Ho-dong, 113, Yejik-ro, Cheoin- 52 CTK Co., Ltd (Ho-dong) gu, Yongin-si, Gyeonggi-do, Korea Unhak-dong 142, Yongin-si, 53 CTK Co., Ltd (Unhak-dong) Gyeonggi-do, Korea Hua Yuan North Rd, Beijing, 54 CTTL (Hua Yuan North Rd) China 55 CTTL (Xue Yuan Road) Xue Yuan Rd, Beijing, China 56 CTTL Beijing BDA Beijing, China 57 CTTL Shenzhen Shenzhen, China One Distribution Center Circle, 58 Curtis-Straus
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    molecules Article Quinolone and Organophosphorus Insecticide Residues in Bivalves and Their Associated Risks in Taiwan 1, 2, 1 3 4 Ching-Feng Wu y , Ching-Hung Chen y, Ching-Yang Wu , Chen-Si Lin , Yao-Chi Su , Ching-Fen Wu 4, Hsiao-Pei Tsai 5,6, Pei-Shan Fan 4, Chang-Hui Yeh 4, Wei-Cheng Yang 3,* and Geng-Ruei Chang 4,5,6,* 1 Division of Thoracic and Cardiovascular Surgery, Department of Surgery, Chang Gung University, Chang Gung Memorial Hospital, Linkou, 5 Fuxing Street., Guishan District, Taoyuan 33305, Taiwan; [email protected] (C.-F.W.); [email protected] (C.-Y.W.) 2 Department of Anesthesiology, Show Chwan Memorial Hospital, 1 Section, 542 Chung-Shan Road, Changhua 50008, Taiwan; [email protected] 3 Department of Veterinary Medicine, School of Veterinary Medicine, National Taiwan University, 4 Section. 1 Roosevelt Road, Taipei 10617, Taiwan; [email protected] 4 Department of Veterinary Medicine, National Chiayi University, 580 Xinmin Road, Chiayi 60054, Taiwan; [email protected] (Y.-C.S.); [email protected] (C.-F.W.); [email protected] (P.-S.F.); [email protected] (C.-H.Y.) 5 College of Veterinary Medicine, Veterinary Teaching Hospital, National Chiayi University, 580 Xinmin Road, Chiayi 60054, Taiwan; [email protected] 6 Ph.D. Program of Agriculture Science, National Chiayi University, 300 Syuefu Road, Chiayi 60004, Taiwan * Correspondence: [email protected] (W.-C.Y.); [email protected] (G.-R.C.); Tel.: +886-2-33663871 (W.-C.Y.); +886-5-2732946 (G.-R.C.) These authors contributed equally to this work.
  • 2021.08.05.21261532V1.Full.Pdf

    2021.08.05.21261532V1.Full.Pdf

    medRxiv preprint doi: https://doi.org/10.1101/2021.08.05.21261532; this version posted August 8, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 1 Title Page 2 Safety and Immunogenicity of CpG 1018 and Aluminium Hydroxide-Adjuvanted 3 SARS-CoV-2 S-2P Protein Vaccine MVC-COV1901: A Large-Scale Double-Blind, 4 Randomised, Placebo-Controlled Phase 2 Trial 5 6 Hsieh Szu-Min, M.D.1, Ming-Che Liu, M.D.,2,3, Yen-Hsu Chen, M.D.,4,5, Wen-Sen Lee, 7 M.D.6,7, Shinn-Jang Hwang, Prof8, Shu-Hsing Cheng, M.D.,9,10, Wen-Chien Ko, Prof.11,12, 8 Kao-Pin Hwang, M.D.13, Ning-Chi Wang, M.D.14, Yu-Lin Lee, M.D.15,16, Yi-Ling Lin, 9 Ph.D.17,18, Shin-Ru Shih, Ph.D.19, ChungGuei Huang, Ph.D.19,20, Chun-Che Liao, Ph.D.17, 10 Jian-Jong Liang, Ph.D.17, Chih-Shin Chang, PhD.18, Charles Chen, adj. Prof.21,22, Chia En 11 Lien, M.D.21,23, I-Chen Tai, M.D.*21, Tzou-Yien Lin, Prof.*24,25 12 13 1. Division of Infectious Diseases, Department of Internal Medicine, National Taiwan 14 University Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan 15 (R.O.C.) 16 2. Clinical Research Centre, Taipei Medical University Hospital, Taipei, Taiwan (R.O.C.) 17 3.
  • Regulatory Update - Indonesia

    Regulatory Update - Indonesia

    Regulatory Update - Indonesia Changes to Accredited Laboratory List for HKT Devices Further to PCS’s Regulatory Update dated 29th January 2020, the Indonesian Regulator - Direktorat Jenderal Sumber Daya dan Perangkat Pos dan Informatika (SDPPI) – has updated the accredited laboratories list whereby a paperwork Type Approval application process can be followed. This updated list is effective immediately, from 27th April 2020. As a reminder, a paperwork-only approach for applications to SDPPI is currently permitted for all devices if all test reports are from an SDPPI-accredited laboratory. In any other case, local testing is still required. This requirement is split into HKT devices (Cellular Phones, Handheld Computers, Computer Tablets) and non-HKT devices (all other categories). For HKT devices, the latest regulation, 107 Tahun 2020, containing the updated list of accredited labs is included as an attachment to this Regulatory Update. The text is in Indonesian language only. There are now 33 labs on this list, down from 45. For non-HKT devices, the latest notice, and the number of accredited labs, has remained the same since 29th January 2020. This is also included as an attachment to this Regulatory Update. There are 150 labs on this list. Both HKT and non-HKT lab lists are valid until 21st July 2020. The searchable table online on SDPPI’s website showing which labs are currently accredited for HKT and non-HKT products is here. ‘YA’ indicates that a lab is accredited; ‘TIDAK’ indicates that a lab is not accredited. For additional information on the above article, please contact: PCS Regulatory Team Email: [email protected] Date of Issue: 29 April 2020 RU2004028 Product Compliance Specialists Ltd.