China, India wind up new medical device industry reg initiatives

China and India are both launching new regulatory guidelines for medical device companies doing business in their countries.

China's State Food and Drug Administration released instructions governing how foreign medical device manufacturers label and package their products, according to Companies have until April 1 to comply.

Essentially, they must make sure product labeling is in Chinese (though other languages can be added), and foreign medical device companies need develop quality control practices that comply with Chinese regulations. Details are contained on a new "circular" issued by the SFDA titled "Circular on Standardizing the Labels and Packaging Marks of Foreign Medical Devices."   

India's new device-related regulatory steps are much more broad. As reports, India's drug controller general will begin a national effort to ensure medical device manufacturers are making sure their products are both safe and effective. India hasn't historically regulated medical device companies separate from drugs and cosmetics, and legislators are contemplating passing a separate regulatory law affecting that industry. Medical device industry-related draft guidance is also pending. In the interim, drug regulators are attempting to step up to the plate.

"Considering the important role that medical devices play in preserving the health of the patients, it is high time to recognize it as an individual entity in line with the drugs and cosmetics in the country," G. N. Singh, the country's drug controller general, told "We hope that steps will be taken by the government to pass the bill at the earliest."

- read the story
- here's the piece