CFDA: Amended regulations pose a big challenge to manufacturers of medical devices

9. May 2014

The amended regulations for registration of medical devices pose a challenge to manufacturers due to the lack of transparency. This non-transparency is based mainly in the fact that there are no English translations and/or the details are often lost when translated. Since most documents and announcements of the Chinese authorities are only available in Chinese, it is difficult for manufacturers to stay current with regulatory amendments and changes.
The last amendments of the China Food and Drug Administration (CFDA, Chinese: 国家食品 药品监督管理总局) regarding the Supervision and Administration of Medical Devices (Chinese: 医疗器械监督管理条例（修订草案）) were announced in February 2014 and published (in Chinese) the following month (March 2014).
The new regulatory amendments affect both the manufacturer planning to start the certification process, as well as manufacturers who have already started the certification process. Manufacturer already in the certification process are placed in a difficult position because they will have to quickly adapt their ongoing certification process to the new regulations. These changes typically result in delays and higher costs for the manufacturers to complete their certification.

Based on the last amendments, a stricter monitoring system and a higher degree of penalties will be enforced.
Three major changes will take place:

• A monitoring system will be set up to identify adverse events.
• A reappraisal mechanism will be implemented for registered products.
• A product recall system will simplify withdrawing flawed products from the market.
  Consequences for non-compliance will be stricter under the new regulations. Manufacturing, distribution and usage of unregistered high-risk medical devices will result in increased penalties. Furthermore, medical devices without official registration and/or certification will be confiscated. Penalties of up to 20 times the value of the medical devices, as well as criminal charges are possible for manufacturers, distributors and buyers, depending on the severity of the risk imposed by the faulty or unregistered products.