+86 21 2215 7611 228 Weihai road • 16F Merchant Plaza • SHANGHAI 200041 • CHINA 

The CFDA issues new regulations on medical devices


The China Food and Drug Administration revised the Medical Device Supervision and Administration Regulations (MDR) and enforced it from June the 1st. As expected, this review, simplifies medical devices’ registration process, but some new regulations are in conflict with the new ones.

A notice has been published about issues bound to paradoxes between the former MDR and update one in which three points are clarified: manufacturers should rely on ‘currently effective provision’ as long as the new rules are not totally validated and effective and medical registrations issued after June 1st have a five year license term (vs 4 with the revised MDR); class II and III devices manufacturers and distributors will follow the current ‘administrative rules and guidance documents’; in case of illegal actions committed before June 1st, penalties will rely on the former MDR.

Source: National Law Forum                                              Date of Publication: 2014-07-03