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  TRAINING FOR CONFORMITY ASSESSMENT BODY (CAB) REGISTRATION

PROGRAM OVERVIEW
This training program is aimed to elucidate the requirements of CAB Registration as required under the Medical Device Regulation 2012, which include the requirements on organisation, resources management, supply chain & Device specific and Surveillance & Vigilance.

TOPIC TO BE COVERED
Medical Device Act (ACT 737) | Medical Device Regulation 2012 | Requirement of Conformity Assessment Procedure (Medical Devices) | Common Submission Dossier Template (CSDT) | Requirements for Conformity Assessment Body (CAB) Registration | CAB Registration Process | Good Distribution Practice for Medical Devices (GDPMD) | MS 2058: 2009

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PENYERTAAN ADALAH DITUTUP (FULLY BOOKED)

PROGRAM TAKLIMAT KAWALAN PERANTI PERUBATAN UNTUK SMALL AND MEDIUM ENTERPRISES (SMEs)

Tarikh    : 24 April 2014
Masa    : 8.30 pagi – 2.00 petang
Lokasi    : Bilik Mesyuarat Utama, PBPP
Peserta    : Syarikat-syarikat SME Peranti Perubatan

Objektif Program:

i)    Memberi pendedahan mengenai Akta 737 (Akta Peranti Perubatan);
ii)    Sistem regulatori peranti perubatan yang telah dilaksanakan serta informasi terkini berkaitan akta dan hal-ehwal peranti perubatan.

Untuk maklumat lanjut, sila hubungi :

Cik Norfazila binti Zulkifli ( This e-mail address is being protected from spam bots, you need JavaScript enabled to view it / 03-8892 2400) 

 


Last Updated ( Tuesday, 22 April 2014 )
 
 
Awareness Program
Presentation Slide : Awareness Program on Medical Device Regulations for Healthcare Facilities [click here]
Training Sessions
Guideline Documents
Guidance Documents

Guidance Documents are prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing the establishment license and medical device registration applications required under the Medical Device Act 2012 ( Act 737). CLICK HERE!

NOTE : Guidance documents are living documents and it will be revised as necessary.

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