Medical Device Act 2012 s 37
(1) An establishment shall maintain a distribution record in respect of each medical device manufactured, imported, exported and placed in the market. (2) The distribution record shall contain information as prescribed by the Minister. (3) An establishment shall provide the distribution records to the Authority upon request.
Rekod pengedaran
(1) Sesuatu establismen hendaklah menyenggara suatu rekod pengedaran berkenaan dengan setiap peranti perubatan yang dibuat, diimport, dieksport dan diletakkan dalam pasaran. (2) Rekod pengedaran itu hendaklah mengandungi maklumat sebagaimana yang ditetapkan oleh Menteri. (3) Sesuatu establismen hendaklah memberikan rekod pengedaran itu kepada Pihak Berkuasa apabila diminta.
Text as at 1 March 2017 (LOM reprint); amendments made after that date may not be incorporated.
Source: Laws of Malaysia, Attorney General's Chambers of Malaysia (lom.agc.gov.my). Not a copy of the Gazette printed by the Government Printer (Interpretation Acts 1948 and 1967, s 61).