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Asia Reg Roundup: Adverse-Event Reporting, Medtech Fees, And More

Executive Summary

Thailand is on the cusp of integrating new medtech adverse-event reporting guidelines, Malaysia is making good headway with its new regulatory system, and the Philippines is moving ahead with plans for a medical device fees schedule. Myanmar and Brunei are among other ASEAN member states included in this latest Asian regulatory update from Medtech Insight.

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Asia Reg Roundup: Malaysia, Vietnam & India Speed Ahead In 2017

Progress on ratifying the ASEAN Medical Device Directive (AMDD) continues apace, with some of the Association of Southeast Asian Nations members surging ahead. Malaysia and Vietnam, in particular, are making big efforts to build or strengthen their national regulatory systems foe devices. Also, non-ASEAN state India is taking real steps in a similar direction, say Asia Regulatory Professional Association (ARPA) secretary Jack Wong and ARQon consultant May Ng in this latest Asian regulatory update.

Asia Reg Roundup: Vietnam Decree, Malaysia Labels And More

Medtech companies selling into the Vietnam market need to start preparing for major regulatory changes that will be introduced in 2017 via a new decree. That is the advice of Asia Regulatory Professional Association (ARPA) secretary Jack Wong and ARQon consultant May Ng, who spoke to Medtech Insight on a range of regional Asian regulatory issues for this September update.

Medtech Gets Two Years To Meet Labeling Rules In Malaysia

Malaysia's Medical Device Authority says the newly introduced two-year transition period for companies to comply with labeling rules should help industry keep costs down.

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