Adakah menjadi satu kesalahan jika establismen tiada rekod pengendalian aduan? | Is it an offense if the establishment does not have complaint handling records?

Ya, kegagalan menyimpan rekod pengendalian aduan adalah suatu perlanggaran terhadap Peraturan-peraturan Peranti Perubatan (Kewajipan dan Obligasi Establismen) 2019, Peraturan 4, sub-peraturan 3. Jika disabitkan boleh didenda tidak melebihi dua ratus ribu ringgit atau dipenjara selama tempoh tidak melebihi dua tahun atau kedua-duanya

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BAHAGIAN PASCAPASARAN & PENGUATKUASAAN (BPP)
03 - 8230 0245

Yes, fail to kept records on a complaint relating to a medical device is an offence against Medical Device Regulations 2019 (Duties and Obligations of Establishments) Regulation 4, sub regulation 3. Any person who contravenes this regulation, shall be liable to a fine not exceeding RM200,000.00 or to imprisonment for a term not exceeding two years or both.

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POST-MARKET & ENFORCEMENT DIVISION (BPP)
03 - 8230 0245