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medical device manufacturers registered with FDA and
medical devices listed with FDA
Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.
Interesting discussion on FDA. Passing by to share my opinions on FDA requirements. Glove is considered a class 1 medical device and hence Premarket approval (PMA) is not needed comparing to class 3 medical devices like implants which requires design controls. Perhaps what is needed to be done by the manufacturer outside of US of any class 1 medical device (which is not exempted) intended to market their products in US is to submit the Premarket notification (510k); at least 90 days ahead. Thereafter, the FDA May perform an on-site inspection at the manufacturer facilities specifically on its quality management systems against relevant CFR standards. Just sharing my opinions, could be wrong. Hope it helps with your research. Please do not hesitate to revert back if my understanding on the requirements is wrong. Helps my understanding on the FDA requirements.
Hi Mohd Annuar, saya cuma singgah bertukar pendapat berkenaan akta US FDA. Pengumuman semalam menunjukkan Notion mematuhi akta yang tertakluk kepada pengilang produk glove yang ingin menjual produknya di pasaran Amerika. Pengumuman pertama berkaitan dengan pelan Notion membina kilang buat glove; jumlahnya 9 line. Fasa pertama - 3 line dan dijadualkan beroperasi pada bulan May 2021 dan baki 6 line pada hujung tahun 2021. Pengumuman kedua berkaitan dengan pelan Notion dalam mematuhi akta di US dan Eropah sebelum dibenarkan menjual produknya di pasaran situ. Akta US FDA membenarkan pengilang produk (1) pembuatan dan pengedaran oleh syarikat sendiri (2) pembuatan oleh OEM dan pengedaran oleh syarikat lain; menjual produknya dipasaran US sekiranya syarikat mematuhi syarat syarat yang tertakluk di dalam akta US FDA. Ini cuma pendapat saya dari segi akta US FDA dan mungkin ada kekurangannya. Tiada pendapat sama ada boleh atau tidak boleh melabur saham Notion.
