India will finally get a device-specific regulatory framework when new rules formed by the government come into force next year. While the medtech industry has welcomed this long-awaited development, it hopes that its outstanding concerns will be addressed before the rules come into play.

An end-of-year flurry of regulatory activity in the Asian medtech markets has kept industry on its toes, with initiatives in China, Taiwan and Korea, among other regions. But as Asia Regulatory Professional Association (ARPA) Secretary Jack Wong and ARQon consultant May Ng observe in this December update for Medtech Insight, governments and companies in certain markets might benefit from a little more pressure in view of the regulatory tasks they face.

Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.