Dear All,
There is an update for Medical device regulations in Malaysia.
Sometime back in Feb 2012, the Govt. has passed the bill and attached is the actual Medical Devices Act-2012.
Also, some presentation slides pertaining to the Medical Devices Act, attached.
Summary of the other ppt is that
- w.e.f 31 Oct 2014, ALL medical devices must be registered before supplying into Malaysia
- a new Medical Devices Authority will be formed by Q3 2012, responsible for reviewing and issuing registration certs
- GHTF Classification structure
- involvement of Conformity Assessment Bodies (CAB) - a 3rd party assessment
- common submission dossier + Declaration of Conformity as submission documents
See attached presentation for more information.
Regards,
Sreenu
There is an update for Medical device regulations in Malaysia.
Sometime back in Feb 2012, the Govt. has passed the bill and attached is the actual Medical Devices Act-2012.
Also, some presentation slides pertaining to the Medical Devices Act, attached.
Summary of the other ppt is that
- w.e.f 31 Oct 2014, ALL medical devices must be registered before supplying into Malaysia
- a new Medical Devices Authority will be formed by Q3 2012, responsible for reviewing and issuing registration certs
- GHTF Classification structure
- involvement of Conformity Assessment Bodies (CAB) - a 3rd party assessment
- common submission dossier + Declaration of Conformity as submission documents
See attached presentation for more information.
Regards,
Sreenu
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