L
Hi MC2012,
I may be helpful on this cause I'm also submitting some medical devices in Singapore and Malaysia.
My answers are on red, hope they work on you!!
1. Is there a simplified CSDT format that I can use?
On both countries the CSDT format is the one that must be applied for submitting your medical devices. If your medical device is already approved by one of the Reference Health Agencies (USA, Canada, Japan, Australia and EU) the abridged route must be followed on which there are less requirements to comply.
Here I attach both guides for Singapore and Malaysia, on where you will find all the documents you need to present.
As a special tip: All the administrative documents (Letter of authorization, CFS and ISO certifications) must be presented by separate while submitting the dossier.
2. Is there a Declaration of Conformity template that I should use?
Here is also attached so you can fill and submit. I took it from Singapore's guidelines.
2. Can a Certificate of Foreign Government (CFG) (obtained from the US FDA) be substituted for the Certificate of Free Sale (CFS)? I'm somewhat confused as the CFS in the United States is given for Food, while the CFG is given for medical devices.
On this one I'm not quite sure because here on Mexico we only manage the CFS for drug products as well as for medical devices and food, but I consulted a contact from Ministry of Health of Malaysia and told me that this document (the CFS) together with the ISO certification and/or GMP certificate of the manufacturing site sustitute the CPP which is given to all health goods on European Community.
You can direct your question to any of the following e-mails:
[email protected], [email protected]
Good luck, best regards!!
I may be helpful on this cause I'm also submitting some medical devices in Singapore and Malaysia.
My answers are on red, hope they work on you!!
1. Is there a simplified CSDT format that I can use?
On both countries the CSDT format is the one that must be applied for submitting your medical devices. If your medical device is already approved by one of the Reference Health Agencies (USA, Canada, Japan, Australia and EU) the abridged route must be followed on which there are less requirements to comply.
Here I attach both guides for Singapore and Malaysia, on where you will find all the documents you need to present.
As a special tip: All the administrative documents (Letter of authorization, CFS and ISO certifications) must be presented by separate while submitting the dossier.
2. Is there a Declaration of Conformity template that I should use?
Here is also attached so you can fill and submit. I took it from Singapore's guidelines.
2. Can a Certificate of Foreign Government (CFG) (obtained from the US FDA) be substituted for the Certificate of Free Sale (CFS)? I'm somewhat confused as the CFS in the United States is given for Food, while the CFG is given for medical devices.
On this one I'm not quite sure because here on Mexico we only manage the CFS for drug products as well as for medical devices and food, but I consulted a contact from Ministry of Health of Malaysia and told me that this document (the CFS) together with the ISO certification and/or GMP certificate of the manufacturing site sustitute the CPP which is given to all health goods on European Community.
You can direct your question to any of the following e-mails:
[email protected], [email protected]
Good luck, best regards!!

Attachments
-
341.6 KB Views: 220
-
GN-17 Guidance on Preparation Product Registration Submission for General Medical Devices using .pdf352.1 KB Views: 178
-
24.5 KB Views: 154