Start Up of Department in a new Medical Device Company

S

sweetasheaven

#1
Dear All,

Happy New Year. I am very happy to have found this forum with all the wonderful people here who can provide me with great discussions on our troubles and worries in the highly regulated industry.

I am going to start my career soon in a new medical device company and will be the only one that is going to run this department for the Asia pacific markets starting with Singapore, Malaysia. As i am new, i would be glad to know what are some of the steps that I can take during my initial joining in the company?

**All their current product registrations are handled by third party consultant and i will only handle the new product registration as well as assist the consultant in the existing and ongoing registrations. They are a company that imports other companies products from overseas.**
 
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#2
A quick "Bump". My Thanks in advance to anyone who can help with this.
 
A

Adele

#4
Hi sweetasheaven,

This is a never-ending question! However, here are a few things I would want clarifiied:
(1) What products to which markets
(2) What are the classifications of the products for the different markets?
(3) A few of the Asia-Pacific countries have a renewal based registrations. Clarify the status of the registrations on those countries.
(4) Build a good relationship with the companies that you are importing products. Give them plenty of notice of upcoming registrations.
(5) if you don't understand their product range ask before you group product registrations together. We had issues where a registration has been rejected as the in-company agent decided to add another product to a registration and it didn't meet the "Family: registration rules.

Am I on the right track of what information you are after?
 
S

sweetasheaven

#5
Hi Adele,

thanks very much for your response. This is indeed a broad question. I have a set of plans on my own but would like to understand more is this the correct way to go about.


1) What products to which markets ( Products wise I am still not very sure right now: Ranging from orthopaedics to detecting machines to simple surgical tools. Markets wise I believe the focus would be on Singapore now)

(2) What are the classifications of the products for the different markets?
( I believe should be in the range from Class B to Class D in Singapore standard )

(3) A few of the Asia-Pacific countries have a renewal based registrations. Clarify the status of the registrations on those countries.
( Currently all their existing registrations are done by third party agent and the plan is for me to work with the agents on existing ones and for me I will take care of the new products registration. Do you think It is possible to ask the agents to send me all the dossiers that they have submitted to the authorities on behalf of the company.)

(4) Build a good relationship with the companies that you are importing products. Give them plenty of notice of upcoming registrations. ( This contact list i will need to obtain when I begin work so as to know who do I liase with to ask for documents. DO you think that they have also compile dossiers in CSDT format before?)

(5) if you don't understand their product range ask before you group product registrations together. We had issues where a registration has been rejected as the in-company agent decided to add another product to a registration and it didn't meet the "Family: registration rules. ( This I believe I need to ask the sales team . the plan is also for me to follow sales team to find out how it works before I can register)

You are on the right track. I am just preparing myself and am thinking what should I do in the first week.
 
S

sweetasheaven

#6
Currently I am trying to compile like a master database which will list the requirements for individual countries registration. Is this useful or?
 
S

sweetasheaven

#7
Hello guys, anyway I am given like a list of objectives to meet by the end of the month and it is only my first day?

Please help me judge whether this is reasonable?

1. Master list of all submitted,pending and approved products

2. Payment tracking sheet for all products submitted to Local authority

3.List of briefing for Malaysia and Singapore regulations

4. Impressions on Indonesia Registration?

5.Collate all past documents from other colleagues

6.One database allocated for devices which is applied through an exemption scheme
 
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