PENJUALAN PERANTI PERUBATAN MELALUI PLATFORM E-DAGANG (SALE OF MEDICAL DEVICES THROUGH E-COMMERCE PLATFORM)

Pihak Berkuasa Peranti Perubatan (PBPP) telah menerima pelbagai pertanyaan dan aduan berkaitan penjualan peranti perubatan tidak berdaftar di platform e-dagang. PBPP ingin menegaskan mana-mana pengedar dan penjual yang hendak menjual dan mengiklankan peranti perubatan di platform e-dagang hendaklah mematuhi semua keperluan pendaftaran, pelesenan dan pengiklanan sebagaimana yang dinyatakan di dalam Akta 737. Akta ini telah menggariskan keperluan pendaftaran kepada mana-mana peranti perubatan yang hendak diimport dan diletakkan di dalam pasaran sebagaimana yang dinyatakan di dalam Seksyen 5(1) Akta 737. Semua peranti perubatan ini perlu memenuhi keperluan-keperluan yang digariskan di dalam Peraturan-Peraturan Peranti Perubatan 2012 yang menghendaki keselamatan dan keberkesanan peranti ini diuji dan disahkan secara klinikal. Setelah keperluan-keperluan ini dipatuhi, barulah peranti perubatan ini didaftarkan dan dibenarkan untuk dipasarkan kepada pengguna dan orang awam.

(The Medical Device Authority (MDA) has received various inquiries and complaints related to the sale of unregistered medical devices on e-commerce platforms. MDA would like to emphasize that any distributor and seller who wants to sell and advertise medical devices on e-commerce platforms must comply with all registration, licensing and advertising requirements as stated in Act 737. This Act has outlined the registration requirements for any medical device. to be imported and placed on the market as specified in Section 5 (1) of Act 737. All these medical devices must meet the requirements outlined in the Medical Devices Regulations 2012 which require the safety and effectiveness of these devices to be tested and certified clinically. Once these requirements are met, only then are these medical devices registered and allowed to be marketed to consumers and the general public.)

For more information, please visit link below;

https://www.mda.gov.my/announcement/608-penjualan-peranti-perubatan-melalui-platform-e-dagang.html