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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) 


 NEW RELEASE 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).

The following are the NEW RELEASED guidance documents for the purpose of medical device registration:

  1. MDA/GD-01 March 2014 First Edition  - DEFINITION OF MEDICAL DEVICE
  2. MDA/GD-02 March 2014 First Edition  - ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES
  3. MDA/GD-03 March 2014 First Edition  - COMMON SUBMISSION DOSSIER TEMPLATE
  4. MDA/GD-04 March 2014 First Edition  - THE RULES OF CLASSIFICATION FOR GENERAL MEDICAL DEVICES

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

 


Last Updated ( Wednesday, 16 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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