In an ongoing effort to refine and improve the systems and procedures for medical device registration in China, the National Medical Products Administration or NMPA (previously the CFDA) moved to a new on-line submission system and harmonized the applications table of contents to international standards.
Tag Archive for: medical device regulations
Learn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.
New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.
China has been making efforts to encourage more direct investment. Along with the new Foreign Investment Law, the NMPA has also announced incentives for manufacturers opening facilities in China by making the application process easier and faster.
Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D.