NMPA Issued the Announcement on Effective Implementation of Unique Identification for the First Batch of Medical Devices
On October 14, 2019, NMPA issued the Announcement on Effective Implementation of Unique Identification for the First Batch of Medical Devices (hereinafter referred to as the Announcement), which clearly defines the scope, schedule and work requirements of unique identification for the first batch of medical devices.
NMPA has formulated and promulgated on August 27, 2019 the Rules for the Unique Identification System of Medical Devices, which will go into effect as from October 1, 2019.
NMPA Issued the Guiding Principles for Capacity Building of Medical Device Inspection and Testing Organizations
NMPA has organized the formulation of and released on August 30,2019 the Guiding Principles for Capacity Building of Medical Device Inspection and Testing Organizations.
The Provisions for Medical Device Registration, adopted at the executive meeting of China Food and Drug Administration on June 27, 2014, is hereby promulgated and shall be effective as of October 1, 2014.
NMPA issued the Announcement on Adjusting the Relevant Matters Concerning the Definition of the Attributes of Drug/Device Combination Products
To further standardize the definition of the attributes of Drug/Device Combination Products, according to the Three- Determinations (of posts, duties and staffing) regulations for NMPA institutions, on May 31, 2019, NMPA announced the relevant matters as follows.
NMPA has organized the development of the electronic Regulated Product Submission (eRPS) system, and announced the relevant issues on May 31, 2019