Persyaratan Mutu Alat Medis Filipina   

Peralatan Medis

Di Filipina peralatan medis yang akan dipasarkan wajib didaftarkan, berikut beberapa peralatan medis yang memerlukan pendaftaran di FIlipina.

Berdasarkan Memorandum Circular No. 2 tahun 1992:

  • Absorbable Collagen Hemostatic Felt
  • Absorbent Cotton sterile and non-sterile
  • Arterial Venous Fistula Needle Set
  • Bandages with Plaster of Paris
  • Bandage, Elastic
  •  Band-Aid Plastic Strip Plain Pad
  • Bone Wax Blood Transfusion
  • Catheters
  •  Cervical Collar 
  •  Collagen
  • Condom
  • Contact Lenses (hard and soft and disposable)
  • Corset Cast
  • Cosmetic Puffs Cotton
  • Cotton Buds
  • Cotton Swabs
  • Dental Filling Ally
  • Disposable Needles
  • Disposable Skin Stapler and Staples
  • Disposable Tissue Measuring Device
  • Drainage Pouches
  • Duodenal Tube
  • Ear Piercing Device
  • Endotracheal Tube
  • Exchange Transfusion
  • Tray Feeding Tube
  • Filter Set
  • Fluor Alloy
  • Amalgam
  • Gauze, sterile and non-sterile
  • Humidifier Mask
  • Hypo-Allergenic Paper Tape
  • Implantable Staple
  • Infusion Administration Set
  • Intraocular Lenses
  • Intrauterine Device (IUD)
  • I.V. Catheter Needles
  • Ligating Clip Device
  • Lubricating Jelly
  • Lumbar Puncture Tray
  • Nasal Oxygen Cannula
  • Nebulizer with Aerosol Mask
  • Orthoplast Cervical Collar
  • Ostotomy Set
  • Oxygen Catheter
  • Oxygen Mask
  • Periodontal Bone Grafting Implant
  • Peritoneal Dialysis Administration Set
  • Plaster
  • Porcine Heart Valve
  • Implantable Prostheses
  • Rectal Catheter
  • Rectal Tube
  • Removable Skin Staple
  • Rotahalers
  • Scalp Vein
  • Infusion Set
  • Scissors Skin Retractors
  • Skin Traction Set
  • Spinal Anesthesia Tray
  • Stomach Bag
  • Stomach Tube
  • Suction Catheter
  • Surgical Blades, disposable
  • Surgical Gloves (sterile and unsterile)
  • Sutures
  • Suturing Needles
  • Synthetic Cast Padding
  • Syringes
  • Thermometers
  • Transfusion Set
  • Urethal Catheter
  • Urinary Drainage Tube
  • Urine Collecting Bag
  • Abdominal Pads
 
Daftar Periksa untuk Registrasi Alat Kesehatan.
  1. Surat Aplikasi yang disahkan dari produsen / pedagang / distributor
  2. Lisensi (perizinan) yang berlaku untuk beroperasi produsen / importir / pedagang / distributor / grosir
  3. Izin Pemerintah dan persetujuan pendaftaran produk dari negara asal yang dikeluarkan oleh Otoritas Kesehatan dan telah dikonfirmasi oleh Konsulat Filipina sebagai produk impor
  4. Sertifikat Pemerintah yang membuktikan status pabrikan, kompetensi, dan keandalan personel dan fasilitas yang dikonfirmasi oleh Konsulat Filipina dan / atau sertifikasi ISO yang berlaku untuk produk yang diimpor
  5. Surat perjanjian antara produsen dan pedagang / distributor / importir tentang produk yang akan diimpor
  6. Petunjuk Penggunaan dan Petunjuk Penggunaan Khusus
  7. Salinan Sertifikat Pendaftaran Produk terbaru (CPR)
  8. Daftar Jumlah dan spesifikasi teknis semua bahan baku.
  9. Deskripsi singkat tentang metode yang digunakan, fasilitas dan kontrol dalam pembuatan, pemrosesan dan pengemasan produk, untuk produk steril, termasuk prosedur sterilisasi.
  10. Spesifikasi teknis dan deskripsi fisik dari produk akhir.
  11. Studi stabilitas produk dan deskripsi fisik produk akhir
  12. Bahan pelabelan yang akan digunakan untuk produk: Label langsung, label kotak, dan sisipan / brosur kemasan, apabila ada
  13. Sampel representatif di pasar atau presentasi komersial (setidaknya satu dari setiap ukuran)
  14. Bukti pendaftaran / pembayaran (slip biaya / tanda terima resmi)
  15. Studi Biokompatibilitas
  16. Studi klinis
  17. Manajemen risiko
Daftar Perizinan Perusahaan Alat Kesehatan (Distributor, Importir, Grosir, Eksportir):
  1. Petikan surat perjanjian (notaris) atau surat pernyataan untuk bekerjasama
  2. Daftar peralatan medis yang akan diimpor atau didistribusikan
  3. Salinan Sertifikat Pendaftaran Apoteker, tugas dan tanggung Jawab, Sertifikat kehadiran pemilik atau apoteker ke Seminar BFAD tentang perizinan perusahaan
  4. Denah lokasi dan denah pabrik lengkap dengan ukuran
  5. Jika perusahaan, sertifikat pendaftaran dengan SEC dan artikel penggabungan atau kemitraan
  6. Jika pemilik tunggal, sertifikat Pendaftaran Nama Bisnis dengan Biro Peraturan Perdagangan dan Perlindungan Konsumen
  7. Kontrak sewa untuk ruang kantor dan penyimpanan untuk ditempati
  8. khusus untuk importir: (-) FAA telah dikonfirmasi oleh Kantor Konsuler Filipina, (-) Sertifikat ISO/GMP produsen.
  9. Khusus untuk produk impor: Certificate of Non-Radiation

Berikut beberapa standar yang diterapkan untuk peralatan medis:

Standar Peralatan Medis

  • PNS ISO 15189:2013 – Medical laboratories – Requirements for quality and competence (ISO published 2012) ICS 03.120.10; 11.100.01

Peralatan Medis Elektrik (Medical Electrical Equipment)

  • PNS BHDT IEC 60601-2-45:2014 - Medical Electrical equipment – Part 2:45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (IEC published 2011) ICS 11.40.50
  • PNS IEC 60601-1: 2016 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC published 2012) ICS 11.040
  • PNS/BHDT IEC 60601-2-54:2014 – Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC published 2009) ICS 11.40.50

Metoda Pengujian Peralatan Medis

  • PNS ISO 7176-28:2013 Wheelchairs – Part 28: Requirements and test methods for stair-climbing devices (ISO published 2012) ICS: 11.180.10
  • PNS ISO 8669-2:2013 Urine collection bags – Part 2: Requirements and test methods (ISO published 1996) ICS: 11.180.20
  • PNS ISO 8670-2:2013 Ostomy collection bags – Part 2: Requirements and test methods (ISO published 1996) ICS: 11.180.20
  • PNS ISO 8670-3:2013 Ostomy collection bags – Part 3: Determination of odour transmission of colostomy and ileostomy bags (ISO published 2000) ICS: 11.180.20
  • PNS ISO 10865-1:2013 Wheelchair containment and occupant retention systems for accessible transport vehicles designed for use by both sitting and standing passengers – Part 1: Systems for rearward-facing wheelchair – seated passengers (ISO published 2012) ICS: 43.100; 11.180.10
  • PNS ISO 11199-1:2013 Walking aids manipulated by both arms – Requirements and test methods – Part 1: Walking frames (ISO published 1999) ICS: 11.180.10
  • PNS ISO 11199-2:2013 Walking aids manipulated by both arms – Requirements and test methods – Part 2: Rollators (ISO published 2005) ICS: 11.180.10
  • PNS ISO 11199-3:2013 Walking aids manipulated by both arms – Requirements and test methods – Part 3: Walking tables (ISO published 2005) ICS: 11.180.10
  • PNS ISO 11334-1:2013 Assistive products for walking manipulated by one arm – Requirements and test methods – Part 1: Elbow crutches (ISO published 2007) ICS: 11.180.10
  • PNS ISO 11334-4:2013 Walking aids manipulated by one arm – Requirements and test methods – Part 4: Walking sticks with three or more legs (ISO published 1999) ICS: 11.180.10
  • PNS ISO 11948-1:2013 Urine-absorbing aids – Part 1: Whole-product testing (ISO published 1996) ICS: 11.180.20
  • PNS ISO 16391:2013 Aids for ostomy and incontinence – Irrigation sets – Requirements and test methods (ISO published 2002) ICS: 11.180.20
  • PNS ISO 16840-2:2013 Wheelchair seating -- Part 2: Determination of physical and mechanical characteristics of devices intended to manage tissue integrity – Seat cushions (ISO published 2007) ICS: 11.180.10
  • PNS ISO 16840-3:2013 Wheelchair seating -- Part 3: Determination of static, impact and repetitive load strengths for postural support devices (ISO published 2006) ICS: 11.180.10
  • PNS ISO 16840-4:2013 Wheelchair seating -- Part 4: Seating systems for use in motor vehicles (ISO published 2009) ICS: 11.180.10
  • PNS ISO 17190-1:2013 Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 1: Determination of pH (ISO published 2001) ICS: 11.180.20
  • PNS ISO 17190-2:2013 Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 2: Determination of amount of residual monomers (ISO published 2001) ICS: 11.180.20
  • PNS ISO 17190-3:2013 Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 3: Determination of particle size distribution by sieve fractionation (ISO published 2001) ICS: 11.180.20
  • PNS ISO 17190-4:2013 Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 4: Determination of moisture content by mass loss upon heating (ISO published 2001) ICS: 11.180.20
  • PNS ISO 17190-5:2013 Urine-absorbing aids for incontinence -- Test methods for characterizing polymer-based absorbent materials -- Part 5: Gravimetric determination of free swell capacity in saline solution (ISO published 2001) ICS: 11.18020
  • PNS ISO 8600-6:2016 - Optics and photonics -- Medical endoscopes and endotherapy evices -- Part 6: Vocabulary (ISO published 2005) ICS 37.020; 11.040.55; 01.040.37
  • PNS ISO 15223-1:2016 - Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements (ISO published 2012) ICS 01.080.20; 11.040.01
  • PNS ISO 14971:2016 - Medical devices -- Application of risk management to medical devices (ISO published 2007) ICS 11.040.01
  • PNS ISO/TR 24971:2016 - Medical devices -- Guidance on the application of ISO 14971 (ISO published 2013) ICS 11.040.01
  • PNS IEC/TR 80002-1:2016 - Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software (IEC published 2009) ICS 35.240.80; 11.040.01

Otoritas Standar di Filipina:

BUREAU OF PHILIPPINE STANDARDS
3F, Trade and Industry Building
361 Sen. Gil Puyat Avenue, Makati City, 1200 Philippines
Telephone (632) 751-3123, 751-4736 • Fax (632) 751-4706
E-mail: bps@dti.dti.gov.ph • www.bps.dti.gov.ph