Medical Device Registration Requirements in ASIAN Countries

L

LQ. Fanny Lozano

#11
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!! :bigwave:
 

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M

MC2012

#12
Hi Fanny,
Thanks for the reply! It helped immensely!

Are you using a Local Authorized Representative? I'm in the process of trying to figure out who to trust and how to hire them.
 
L

LQ. Fanny Lozano

#13
Im glad that it helped! Our company has some contacts in those countries and yes, we are making this happen with help of a Local Authorized Representative but some other department on the company is handling this commercial process so I really don't know much of that. Anyway, if you have a chance write to the emails I gave you before and there special staff of the Health Authorities of Singapore and Malaysia from the Medical Device Branch will help you out to find a good representative.
Im pretty sure that the guides I gave you will be very useful.
Good luck with that, regards!!
 
S

sweetasheaven

#14
Hello guys, am very glad to have found this forum and hope that you guys could help me out too. Like MC, I am also new to this and am going to embark on my journey in doing product registration in the ASEAN countries.
 
S

sweetasheaven

#15
anyway as I was reading through the guidelines for both Malaysia and Singapore, I realize that there is actually no difference in the format and requirements for CSDT. Please correct me if I am wrong?
 
S

sweetasheaven

#16
anyway guys, as I am relatively new, I would also like to know from you guys on any upcoming conferences that can be attended to strengthen my understanding in this area? =)
 
Y

ymunwai

#17
Hi, Just to add on to the posts. I know that Singapore requires GDPMDS for medical device distribution in Singapore. Since you are importing to ASEAN countries, it is worth while to also look at GDP( Good Distribution Practise) for your local distribution.
 
Last edited by a moderator:

Marcelo

Inactive Registered Visitor
#18
Hi, Just to add on to the posts. I know that Singapore requires GDPMDS for medical device distribution in Singapore. Since you are importing to ASEAN countries, it is worth while to also look at GDP( Good Distribution Practise) for your local distribution.
Hello ymunwai

Thanks for your help. However, I would ask you that you refrain from requiring private contact for information exchange. The Cove is an open discussion and information sharing forum - for the benefit of all Covers.
 
E

esh14

#19
I guess there is no difference in Malaysia and Singapore CSDT as I think there is only one format for ASEAN countries... Its called ASEAN CSDT.... Please correct me if I am wrong....
 
P

psureshkumar4

#20
Thank you for the information stated above specifically: <snip>
Dear Forum members, I am preparing a device application for Singapore market, Could some body help me in providing the templates/ inputs what information to be included under essential principle and manufacturing process? Best regards, Kumar
 
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