The registration and review matters of ECMO cycle package are further refined!

On June 10, CMDE issued the Notice on Soliciting Comments on the Guidelines for the Examination of Registration of Extracorporeal Membrane Oxygenation (ECMO) Cycle packages (Draft for Comments).

The  “Principles” mentions that it will serve as technical guidance documents for registration applicants and reviewers, but does not cover the administrative matters involved in registration approval, nor will it be enforced as regulations.In addition, the package referred to in the Principles refers to passive medical devices and does not include membrane oxygenators and accessories for cardiopulmonary bypass systems for a maximum of 6 hours of continuous use, other vascular access (such as arteriovenous catheterization, disposable suction tubes, arterial  line blood filters, etc.), and active medical devices.

The “Principles” specifies the specific requirements for package registration declaration materials, registration unit division principles and testing, product specifications and label samples of the minimum sales unit.

At the same time, the “Principles” mentions that the registration applicant should enrich and refine the content of the registration application materials according to the characteristics of the products, and determine whether the specific content is applicable according to the characteristics of the specific products. If not, the reasons and corresponding scientific basis should be elaborated in detail.

For a complete English copy of the Notice on Soliciting Comments on the Guidelines for the Examination of Registration of Extracorporeal Membrane Oxygenation (ECMO) Cycle packages (Draft for Comments)，please email info@inspirativemed.com