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Asia Pacific

Set Alert for Asia Pacific

Malaysia Consults On Facilitating Exports By Original Equipment Manufacturers

The Malaysian medtech regulator has issued a new circular and a related draft guidance to facilitate the export of medical devices manufactured by original equipment manufacturers.

Malaysia Regulation Trade

Tougher Sanctions And Penalties Kick In For Advertising Breaches In Australia

Australia has introduced new civil penalties and amended criminal offense provisions for breaches of its therapeutic product advertising rules. More reforms to the advertising regulations are expected soon.

Advertising, Marketing & Sales Policy & Regulation

Goodbye CFDA, Hello MRA: China Overhauls Regulatory Bodies

China proposes to merge its top drug and device regulator into a new combined body and create a medical reimbursement agency in moves directed at strengthening regulatory oversight.

Regulation Reimbursement

India Mandates Registration For Device & IVD Testing Labs

Indian laboratories that manufacturers employ to test their products will now need to be registered with health-care product regulator CDSCO.

In Vitro Diagnostics Regulation

India’s Pricing Authority Head Shunted Out?

India’s firebrand pharma pricing authority chief has been transferred out amid sharply polarized views on either side of the debate around his controversial stint.

India Policy & Regulation

Regulator Answers Industry's Questions About India’s New Medical Device Rules

A new FAQ document from India's health-care products regulator clarifies requirements relating to manufacturing licenses and other issues under the new medical device rules that came into effect on Jan. 1.

India Compliance

India’s Top Regulator ‘Relieved Of Post’; Temporary Head In Place

India has appointed a temporary head for its Central Drugs Standard Control Organization, after terminating GN Singh’s position.

India Policy & Regulation
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