Berlangganan Pro

Jumat, Oktober 6, 2023

Six Medical Devices Stipulated as Priority Products for Post-Market Testing

Pharmacies, Health Industry, and Foods & Drugs Standard

The Director-General of Pharmaceutical and Medical Devices has issued Circular No. HK.02.02/E/1721/2023 on the Post-Market Testing ("Testing") of Medical Devices, which has been in force since 20 September 2023 and which should be complied with by holders of circulation permits for: 1) Medical devices; and 2) Diagnostic in-vitro medical devices (collectively referred to as "Permit Holders").
Permit Holders are encouraged to complete the independent Testing of all circulated products (produk di peredaran) in order to ensure that said products still fulfill the relevant safety, quality and benefits requirements. A total of six product categories have been designated for Testing, including: 1) Prenatal ultrasound (USG), continuous ventilators, infusion pumps and syringe pumps; 2) Disposable syringes, IV cannulas, catheters, wing needles, fistula needles and infusion sets with needles; and 3) IVD for RDT HIV, syphilis, hepatitis and dengue. The Testing methods that should be applied differ and have been stipulated in accordance with the relevant types of medical devices and products, as listed under Appendix II to the Circular.
Testing should be completed at least once every two years through accredited testing laboratories in line with the following overall mechanism: 1) Taking of samples; 2) Delivery of samples; 3) Sample testing; 4) Reporting; and 5) Follow-ups. Details of this mechanism are illustrated under Appendices III - IV to the Circular.

......

Sudah memiliki akun? Masuk

Hukumonline Pro

Berlangganan sekarang untuk akses tak terbatas ke berbagai Analisis Hukum!

Tingkatkan kualitas penelitian hukum Anda dengan berlangganan Paket Professional Hukumonline Pro dan dapatkan lebih banyak analisis hukum untuk referensi yang komprehensif

PRO PLUS

Rp 7.500.000

per bulan

Semua Fitur Paket Professional
Layanan Penerjemahan Peraturan
Precedent Hukumonline
Virtual Discussion

PROFESSIONAL

Rp 4.500.000

per bulan

Semua Fitur Paket Standard
Terjemahan Peraturan
Peraturan Konsolidasi
Premium Stories
Monthly Law Review (MLR)
Indonesian Law Digest (ILD)

STANDARD

Rp 2.500.000

per bulan

Indonesian Legal Brief (ILB)
Daily Updates
Bantuan Layanan Pencarian Peraturan
Pusat Data Peraturan dan Putusan Pengadilan Non-Precedent

The Director-General of Pharmaceutical and Medical Devices has issued Circular No. HK.02.02/E/1721/2023 on the Post-Market Testing ("Testing") of Medical Devices, which has been in force since 20 September 2023 and which should be complied with by holders of circulation permits for: 1) Medical devices; and 2) Diagnostic in-vitro medical devices (collectively referred to as "Permit Holders").
Permit Holders are encouraged to complete the independent Testing of all circulated products (produk di peredaran) in order to ensure that said products still fulfill the relevant safety, quality and benefits requirements. A total of six product categories have been designated for Testing, including: 1) Prenatal ultrasound (USG), continuous ventilators, infusion pumps and syringe pumps; 2) Disposable syringes, IV cannulas, catheters, wing needles, fistula needles and infusion sets with needles; and 3) IVD for RDT HIV, syphilis, hepatitis and dengue. The Testing methods that should be applied differ and have been stipulated in accordance with the relevant types of medical devices and products, as listed under Appendix II to the Circular.
Testing should be completed at least once every two years through accredited testing laboratories in line with the following overall mechanism: 1) Taking of samples; 2) Delivery of samples; 3) Sample testing; 4) Reporting; and 5) Follow-ups. Details of this mechanism are illustrated under Appendices III - IV to the Circular.

......

Sudah memiliki akun? Masuk

Hukumonline Pro

Berlangganan sekarang untuk akses tak terbatas ke berbagai Analisis Hukum!

Tingkatkan kualitas penelitian hukum Anda dengan berlangganan Paket Professional Hukumonline Pro dan dapatkan lebih banyak analisis hukum untuk referensi yang komprehensif

PRO PLUS

Rp 7.500.000

per bulan

Semua Fitur Paket Professional
Layanan Penerjemahan Peraturan
Precedent Hukumonline
Virtual Discussion

PROFESSIONAL

Rp 4.500.000

per bulan

Semua Fitur Paket Standard
Terjemahan Peraturan
Peraturan Konsolidasi
Premium Stories
Monthly Law Review (MLR)
Indonesian Law Digest (ILD)

STANDARD

Rp 2.500.000

per bulan

Indonesian Legal Brief (ILB)
Daily Updates
Bantuan Layanan Pencarian Peraturan
Pusat Data Peraturan dan Putusan Pengadilan Non-Precedent

Latest Analysis

2024 Hak Cipta Milik Hukumonline.com