Apakah yang dimaksudkan dengan pengecualian bagi tujuan demonstrasi pemasaran? | What is meant by exemption for demonstration for marketing purposes?

Pengecualian bagi tujuan demonstrasi pemasaran adalah bermaksud:

a. Aktiviti untuk memperkenalkan peranti perubatan kepada pasaran luas seperti dalam pameran perdagangan, pameran, atau perhimpunan saintifik atau teknikal yang tidak digunakan pada manusia bertujuan mengumpul maklumat pemasaran dalam tempoh tertentu sebelum peranti perubatan didaftarkan. Dalam tempoh demonstrasi pemasaran, semua aktiviti pemasaran seperti promosi dan pengedaran maklumat melalui poster, notis, brosur, risalah, sepanduk, bunting, gambar, klip video dengan maklumat terhad tentang spesifikasi dan ciri-ciri peranti dibenarkan.

b. Bagi peranti IVD, ia juga termasuk aktiviti ujian kebolehpercayaan atau kualiti, di mana keputusan yang diperoleh hanya digunakan untuk meningkatkan kepercayaan dan keyakinan terhadap peranti perubatan. Keputusan ini tidak boleh digunakan untuk menyokong atau menolak diagnosis/perawatan pesakit.

Untuk maklumat lanjut, rujuk dokumen panduan melalui pautan: https://portal.mda.gov.my/index.php/documents/guidance-documents/1801-import-and-or-supply-of-unregistered-medical-devices-for-the-purpose-of-demonstration-for-marketing-or-education/file

Exemption for marketing demonstration purposes are as follows:

a. An activity to introduce a medical device to the vast market e.g. in trade fairs or exhibition or scientific or technical gatherings which is not to be used on human for a purpose to gather marketing information in a specific period of time before the device being registered. In the period of marketing demonstration, all marketing activities such as promoting and information distribution such as posters, notices, brochures, pamphlets, banners, buntings, photographs, video clips with limited information specifically on device’s specification and features are allowed.

b. For IVD device, it also includes reliability or quality testing activity(ies), where the result obtained are solely used for the purpose of enhancing trust and confidence towards the device(s). In this instance, the result cannot be used to support or reject patient’s diagnosis / treatment.

For more information, refer to the guidance document via the link: https://portal.mda.gov.my/index.php/documents/guidance-documents/1801-import-and-or-supply-of-unregistered-medical-devices-for-the-purpose-of-demonstration-for-marketing-or-education/file