April 6, 2018

Indian Parliament Critical of Policy That Favors FDA-Approved Devices

India’s Parliamentary Standing Committee was critical of a health department policy that required U.S. FDA approval or CE marking for devices sold in India where Indian standards are not available.

The critics were responding to a health department circular that said organizations that procured devices could insist on FDA approval or European CE marking when domestic quality standards were questionable.

Domestic associations also were critical of the ministry, saying that other standards such as ISO or ICMED could be used to verify quality standards.

Japan Updates Standards for Device Connectors

Japan’s Pharmaceuticals and Medical Devices Agency is revising standards for connectors of medical devices to prevent misconnections across different product areas.

The regulator said new standard products in each product area should be marketed in sequence and that new and old standard products will not connect with each other.

The standards will apply to neuroaxial applications, breathing systems, enteral applications, urethral and urinary applications and limb cuff inflation applications.

Brazil Requires Anatel Certification for Wireless Devices

Brazil’s National Agency of Sanitary Surveillance is requiring wireless medical devices to be certified by Anatel, the country’s telecommunications agency, and devicemakers wanting to register wireless devices in Brazil, must include an Anatel certificate when they submit their applications.

The regulator said the move would help ensure safety and efficacy of health products and the technologies with which they interface.