Ekspor Produk Peralatan Medis ke Filipina

1. Ketentuan Umum.

Ekspor peralatan medis (medical devices) ke Filipina memerlukan pendaftaran produk sesuai dengan regulasi di Filipina, yaitu peralatan medis yang akan dipasarkan di Filipina wajib didaftarkan, berikut beberapa peralatan medis yang memerlukan pendaftaran di FIlipina meurut 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 (Check List) - Pendaftaran Alat Kesehatan.

Surat Aplikasi yang disahkan dari produsen / pedagang / distributor
Lisensi (perizinan) yang berlaku untuk beroperasi produsen / importir / pedagang / distributor / grosir
Izin Pemerintah dan persetujuan pendaftaran produk dari negara asal yang dikeluarkan oleh Otoritas Kesehatan dan telah dikonfirmasi oleh Konsulat Filipina sebagai produk impor
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
Surat perjanjian antara produsen dan pedagang / distributor / importir tentang produk yang akan diimpor
Petunjuk Penggunaan dan Petunjuk Penggunaan Khusus
Salinan Sertifikat Pendaftaran Produk terbaru (CPR)
Daftar Jumlah dan spesifikasi teknis semua bahan baku.
Deskripsi singkat tentang metode yang digunakan, fasilitas dan kontrol dalam pembuatan, pemrosesan dan pengemasan produk, untuk produk steril, termasuk prosedur sterilisasi.
Spesifikasi teknis dan deskripsi fisik dari produk akhir.
Studi stabilitas produk dan deskripsi fisik produk akhir
Bahan pelabelan yang akan digunakan untuk produk: Label langsung, label kotak, dan sisipan / brosur kemasan, apabila ada
Sampel representatif di pasar atau presentasi komersial (setidaknya satu dari setiap ukuran)
Bukti pendaftaran / pembayaran (slip biaya / tanda terima resmi)
Studi Biokompatibilitas
Studi klinis
Manajemen risiko

Daftar Perizinan Perusahaan Alat Kesehatan (Distributor, Importir, Grosir, Eksportir):

Petikan surat perjanjian (notaris) atau surat pernyataan untuk bekerjasama
Daftar peralatan medis yang akan diimpor atau didistribusikan
Salinan Sertifikat Pendaftaran Apoteker, tugas dan tanggung Jawab, Sertifikat kehadiran pemilik atau apoteker ke Seminar BFAD tentang perizinan perusahaan
Denah lokasi dan denah pabrik lengkap dengan ukuran
Jika perusahaan, sertifikat pendaftaran dengan SEC dan artikel penggabungan atau kemitraan
Jika pemilik tunggal, sertifikat Pendaftaran Nama Bisnis dengan Biro Peraturan Perdagangan dan Perlindungan Konsumen
Kontrak sewa untuk ruang kantor dan penyimpanan untuk ditempati
khusus untuk importir: (-) FAA telah dikonfirmasi oleh Kantor Konsuler Filipina, (-) Sertifikat ISO/GMP produsen.
Khusus untuk produk impor: Certificate of Non-Radiation

2. Standar

2.1 Laboratorium Medis.

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

2.2 Peralatan Medis Listrik.

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

2.3 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

3. 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

Diterbitkan pada 20 Aug 2022