The China FDA has released for comment a draft regulation covering exports of medical devices. The draft would require a slew of records covering the equipment so officials can track fraudulent data and production and exporting methods.
Any wrongdoing the agency finds in those records would result in the makers being publicly named, shamed and banned from the market for two years, according to Xinhua, the state news agency.
The proposal would require devicemakers to maintain records of sales certificates, procurement contracts, quality standards, examination reports, custom declaration forms and even packaging information for what the news agency termed "backtracking."
- here's the story from Xinhua