Clinical Evaluation is a form of clinical study to evaluate the conformity of medical devices of it safety and performance as per intended purpose.
The requirement of the Clinical Evaluation has been clearly stated in the Clinical Evaluation guideline such as MEDDEV 2.7.1, MEDDEV 1.12 and ISO 14155 which are the standard and guidance for the documentation and reporting requirements.
Clinical evaluation need to be carried out for all the medical device, regardless of the classification and risk associate. The current development in the EU regulatory had emphasis on a few medical device related requirements to be enforce such as the proper Clinical Study of Pre and Post Market. The focus was streamlined as there are an increase number of faulty medical devices in the EU market and the study had shown that the lack of proper Clinical Evaluation and study is one of the main factor that cause the incompetent devices being introduce in the market such as the EU.
Looking into these scenario, the Ministry of Health had impose its Medical Device Act, 737 starting February 2012 and finally start the implementation dated 1th July 2013. The requirement of companies not only to certify with either ISO 13485 or GDPMD, they also need show the prove of product safety and performance had been made by collating the Technical File or in this case, is called CSDT (Common Submission Dossier Template).
To get more information regarding the above, Kindly contact 017-2130501 Azrin to get more detail and explanation.
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IMPORTANT ANNOUNCEMENT!
Please be inform that UMMAH SYNERGY RESOURCES does not have any ASSOCIATION what so ever, with UMMAH SYNERGY CORPORATION.
We shall not be subjected to any liability and to any legal claim deriving from any negligence and/or misconduct act/advice/conduct produced or caused by any UMMAH SYNERGY CORPORATION personnel or any third party appointed by UMMAH SYNERGY CORPORATION.
For more information, kindly call 017-2130501.
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Latest Update from Medical Device Control Division - 2013
ANNOUNCEMENT ON THE MEDICAL DEVICE REGULATION 2012
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations can be downloaded via the following link:
MEDICAL DEVICE REGULATIONS 2012
Among others, the Regulations specify requirements and procedural matters pertaining to medical device registration, conformity assessment body (CAB) registration, establishment licensing, export permit and appeal.
The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
With the gazettement of the Regulations, those affected shall take the necessary steps and measures to ensure they comply with the regulatory requirements as specified under the medical device law.
For further inquiries, please contact us at 03-8885 0778 or email us at mdb@mdb.gov.my.
MEDICAL DEVICE REGULATIONS 2012Among others, the Regulations specify requirements and procedural matters pertaining to medical device registration, conformity assessment body (CAB) registration, establishment licensing, export permit and appeal.
With the gazettement of the Regulations, those affected shall take the necessary steps and measures to ensure they comply with the regulatory requirements as specified under the medical device law.
For further inquiries, please contact us at 03-8885 0778 or email us at mdb@mdb.gov.my.
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Good Manufacturing Practice (GMP) ... berapakah kos sebenar?
Good Manufacturing Practice (GMP) adalah salah satu dari keperluan kepada proses-proses pembuatan di dalam bidang medikal, farmasutikal dan makanan.
Terdapat pelbagai tanggapan berkenaan tatacara untuk mendapatkan persijilan GMP dan juga keperluan kepada penambahan-penambahan infrastruktur kepada premis pembuatan terlibat.
Keperluan-keperluan infrastruktur untuk keperluan GMP adalah bersifat generik dan sangat bergantung kepada produk yang akan diproses. Namun, dengan konsultansi yang salah atau andaian-andaian berkenaan kos yang diperlukan untuk spesifikasi-spesifikasi sesuatu premis itu, membuatkan kos-kos untuk pengubahsuaikan infrastuktur menjadi terlalu mahal dan tidak releven.
Tahukah anda, dengan maklumat yang betul dan justifikasi perlaksanaan kawalan risiko yang betul, sesuatu organisasi itu akan dapat mengurangkan perbelanjaan kos-kos pengubahsuaian sehingga tahap paling minima? (mungkin tidak perlu membuat apa-apa perubahan besar kepada premis anda)
Anda memerlukan khidmat nasihat berkenaan GMP? Hubungi kami untuk berbincang.
Azrin 017-2130501
Terdapat pelbagai tanggapan berkenaan tatacara untuk mendapatkan persijilan GMP dan juga keperluan kepada penambahan-penambahan infrastruktur kepada premis pembuatan terlibat.
Keperluan-keperluan infrastruktur untuk keperluan GMP adalah bersifat generik dan sangat bergantung kepada produk yang akan diproses. Namun, dengan konsultansi yang salah atau andaian-andaian berkenaan kos yang diperlukan untuk spesifikasi-spesifikasi sesuatu premis itu, membuatkan kos-kos untuk pengubahsuaikan infrastuktur menjadi terlalu mahal dan tidak releven.
Tahukah anda, dengan maklumat yang betul dan justifikasi perlaksanaan kawalan risiko yang betul, sesuatu organisasi itu akan dapat mengurangkan perbelanjaan kos-kos pengubahsuaian sehingga tahap paling minima? (mungkin tidak perlu membuat apa-apa perubahan besar kepada premis anda)
Anda memerlukan khidmat nasihat berkenaan GMP? Hubungi kami untuk berbincang.
Azrin 017-2130501
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