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Indonesia: List Of SNI ISO/IEC 17025:2017 Accredited Testing Laboratories For Medical Devices And Household Supplies In Indonesia

On 5 December 2023, the General Director of Pharmaceuticals and Medical Devices of the Ministry of Health (MoH) of Indonesia released a circulation letter No: HK.02.02/E/2379/2023 regarding the List of SNI ISO/IEC 17025:2017 Accredited Testing Laboratories for Medical Devices and Household Supplies. SNI itself is an abbreviation of Standar Nasional Indonesia or Indonesian National Standards.

Availability of SNI ISO/IEC 17025:2017 accredited testing laboratories for medical device and household supplies aims to support efforts to ensure the quality of medical devices and household supplies through the pre-market and post-market testing, including domestic products.

List of testing laboratories and information on products that can be tested, types of testing and its methods will be updated continuously along with the development of strengthening the network of medical device testing laboratories and households.

Below is the summary of 13 testing laboratories for Medical Devices (excluding Household Supplies) along with the scope products that could be tested:

No Laboratory Name Tested Product/Material
1 Balai Pengamanan Fasilitas Kesehatan (BPFK) Jakarta Infusion Pump, Syringe Pump, Ultra sonograph, Portable Oxygen Concentrator, Ventilator Emergency, Suction Pump, Autoclave, Centrifuge, Centrifuge Refrigerator, Electro Convulsion Therapy (ECT), Ultrasonography (USG), Laboratorium Freezer, Operation Lamp, Personal Negative Pressure Chamber, Photo Therapy Unit/Blue Light, Power Emergency Resuscitator. Defibrillator/ DC Shock, Defibrillator Monitor, Defibrillator with Electrocardiograph (ECG) with SPO2, Infant Warmer, Baby Incubator, Ultrasound Therapy (UST), Continuous Positive Airway Pressure (CPAP). General Purpose XRay, Electric Bed Hospital Patient. General Purpose XRay, Bed Pasien Hospital. Sphygmomanometer
2 Balai Besar Laboratorium Kesehatan (BBLK) Jakarta Rapid Diagnostic Test (RDT): Antigen COVID-19 Pre-market: Sensitivity, Specificity Post-market: Physical and Functional Test Anti Syphilis (TP) Pre-market: Sensitivity, Specificity Post-market: Physical and Functional Test Anti HCV Pre-market: Sensitivity, Specificity Post-market: Physical and Functional Test HbsAg Pre-market: Sensitivity, Specificity Post-market: Physical and Functional Test Anti-HIV Pre-market: Sensitivity, Specificity Post-market: Physical and Functional Test Reagen PCR Covid-19 Medical Mask
3 Balai Besar Laboratorium Kesehatan (BBLK) Surabaya Rapid Diagnostic Test (RDT): Antigen COVID-19 Pre-market: Sensitivity, Specificity Post-market: Physical and Functional Test Anti Syphilis (TP) Pre-market: Sensitivity, Specificity Post-market: Physical and Functional Test Anti HCV Pre-market: Sensitivity, Specificity Post-market: Physical and Functional Test HbsAg Pre-market: Sensitivity, Specificity Post-market: Physical and Functional Test Anti-HIV Pre-market: Sensitivity, Specificity Post-market: Physical and Functional Test
4 Balai Besar Standardisasi dan Pelayanan Jasa Industri Tekstil Bandung Medical mask, Protective clothes
5 Unit Kerja Khusus Pelayanan danPengabdian Masyarakat - Laboratorium Mikrobiologi Klinik Fakultas Kedokteran Universitas Indonesia (LMK FKUI) RDT Antigen Covid19 Kit PCR Covid-19
6 Rumah Sakit Universitas Indonesia - Unit Laboratorium Terpadu PCR Kit for SARS Detection HIV Antibody RDT, Covid-19 Antigen RDT, Hepatitis Antigen RDT (HBsAg), Syphilis Antibody RDT, Hepatitis C Antibody RDT. Post market test: Physical and Functional Test
7 Unit Layanan Pengujian Fakultas Farmasi Universitas Airlangga (ULP FFUA) disposable syringe, feeding tube, folley catheter, infusion set, IV catheter, stomach tube, suction catheter steril, surgical gloves, surgical suture, wing needle, stopcock tube, dermafix, catgut surgical Type test: Sterility
8 Fakultas Kedokteran Universitas Padjadjaran - Laboratorium Biomedik RDT Antigen Covid-19 RDT Antigen Malaria
9 Laboratorium Kualitas Udara, Teknik Sipil dan Lingkungan – Institut Teknologi Bandung Masks (medical & cloth masks)
10 PT Saraswanti Indo Genetech Sanitary Napkin, Medical mask, Pad, Basic dressing set, wound sewing thread, Blood Transfusion Set, Foley Catheter, Infusion set, inge, Urine bag, Blood bag, Sterile gauze, Surgical gloves, Contact lenses, Infusion hose, Suction Catheter with Tumb Control, Wing Needle, Swab Test Equipment, Syringe.
11 PT Sucofindo (Persero) SBU Laboratory Sanitary napkins, Urine bag, Foley Catheters, IV Catheters, Infusion sets, Sterile Gloves, Implant, Syringes, Contact Lenses, Calgut Suture, Sterile Gauze. Weighing machines for children under five, children, and adult, Sphygmomanometer non-automatic. Medical electronic equipment, Infant incubator, medical bed, Wheeled steel bed for hospital, Male condoms.
12 PT Intertek Utama Services Surgical GownSNI 8913:2020
13 PT Pharma Metric Labs Surgical Suture, Multifilament surgical suture, Medical Devices (bioburden test), Diagnostik Kit Realtime-PCR Kit SARSCov-2, Raw Material Diagnostik Kit Saliva Nucleic Acid SARSCov-2, Diagnostik Kit Saliva Nucleic Acid SARSCov-2

The circulation letter No. HK.02.02/E/2379/2023 and the list of the laboratories for further information can be accessed here.

Should you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.

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