Medical Device Regulations in Malaysia 2012 Update

sreenu927

Quite Involved in Discussions
#1
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
 

Attachments

Elsmar Forum Sponsor
B

bharatbuk

#3
The Medical Device Control Division (MDCD) is a division in the Ministry of Health Malaysia (MOH) charged with the role of regulating medical device and its industry players in Malaysia.As part of the 2011 Medical Device Act ratified by the Malaysian parliament late last year, the regulatory changes are intended to protect domestic businesses from patent infringement and patients from the health risks posed by low-quality devices.
 
T

theQuestion

#4
Hello all,

From what I have read, it seems like the new regulatory system is effective July 2013. This being the case, is a voluntary registration system still in place? Can we bring our product into the market now as long as we register it before the November 2014 deadline?

Thanks
 

tibon74

Involved In Discussions
#7
Hello,

Should the foreign manufactruer have an establishment license to register the medical devices in Malaysia?

thank you !
 

Murni Ahmad

Involved In Discussions
#8
Hello,

Should the foreign manufactruer have an establishment license to register the medical devices in Malaysia?

thank you !

For Foreign manufacturer
They must appoint local company as Local Authorized Representative.
Only LAR will need to have establishment license, not the foreign manufacturer.

Additional note : LAR will do the registration on behalf of foreign manufacturer.
 
Last edited:

sreenu927

Quite Involved in Discussions
#10
What is the GDPMDS Scope for LAR in Malaysia? When I read the GDPMDS guidance doc, the scope of certification is as below:

- Import
- Storage & Handling
- Warehousing
- secondary assembly
- Distribution
- installation, testing and commissioning
- Maintenance and Calibration
- Documentation (including traceability of medical devices)

If AR is just doing product registration on behalf of foreign manufacturer, then what should be the content for the Regulatory Compliance Manual for GDPMDS Cert?

Regards,
Sreenu
 
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