Hello,
Yes, you are right. In Asia-Pacific region, there are several countries issuing new guidelines recently.
The ASEAN harmonized guidelines for MD, is already being implemented this year especially for Philippines & Thailand.
In India, the new regulations, Indian MDR 2017 has been into force last year all the manufacturers located outside India or within India have started following them and receiving approvals.
The approval time-lines would be 8 months to 1 year considering pandemic crisis and shortage of staff.
Cost of registration varies for each country.
Hope this information is useful !
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Purvi Goradia
Manager Regulatory Affairs
India.
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Original Message:
Sent: 25-May-2021 21:32
From: Anonymous Member
Subject: Asia pacific
This message was posted by a user wishing to remain anonymous
Over the past few years many of the countries in the AP region have either changed their regulations or have anounced their intention to update. Unfortunatly, because of COVID I am not sure where we are with the countries below. What I am looking for is the realistic registration tyimes and approximate regulator costs for registration. This could be as simple as 3-6 months and US$1000. The products are all Class IIa active.
Also, I am seeing updates from several countries regarding the ASEAN Harmonisation but is this really happening.
Vietnam*, Philippines, Hong Kong, Taiwan,Thialand*, Malaysia and India.
* recently announced major reviews.
Regards and thanks
B