Medical Devices

NMPA report on the registration of medical devices in 2013, 2014, 2015
NMPA report on the registration of medical devices in 2013, 2014, 2015

In 2015, the NMPA approved a total of 7,530 registrations for Class II and III products comparingly less than 2013 (7,875) and 2014 (8,834).

March 9, 2026
NMPA report on the registration of medical devices in 2013, 2014, 2015
NMPA Issues Charging Standards for Drug and Medical Device Registration
NMPA Issues Charging Standards for Drug and Medical Device Registration

NMPA Issues Charging Standards for Drug and Medical Device RegistrationOn May 27, the China Food and Drug Administration ("NMPA") released its “Charging Standards for Registration of Drugs and Medical Devices” which come into force immediately. For pharmaceuticals, foreign companies will have to pay for clinical trials or marketing approvals, medical device companies have to pay for class II and III registration. This applies to new and change applications as well as the extension after five years.For small to micro enterprises in China doing medical innovation, the NMPA has set up a preferential policy of waiving registration fees and supplementary application fees.For more information please contact us at:Cisema China Certification GmbHTel.: +49 89 4161 7389 - 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

March 9, 2026
NMPA Issues Charging Standards for Drug and Medical Device Registration
Four professionals sit around a meeting table reviewing printed documents and binders related to product registration and regulatory compliance. A laptop screen displays “Product Registration Dossier,” while one person points to highlighted sections.
Vietnam Consolidates Medical Device Rules Under Decree 98 Framework

Vietnam’s Ministry of Health issued “Consolidated Document No. 08/VBHN-BYT (2026)”, unifying medical device regulations.

Vietnam Consolidates Medical Device Rules Under Decree 98 Framework

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