Registration submissions for exempted products should include a detailed comparison of the device and a predicate device that is already on the market. Manufacturers should provide the principle of operation, product material, physical structure and components, main technical performance index, sterilization or disinfection method, if needed, intended use and whether the device is for home use, says Jack Wong, director of regulatory affairs for Asia Pacific at Terumo’s Singapore branch.
The change does not affect registration submissions that the CFDA received before Oct. 11. The Class II exemption is one of several new device regulations aimed at improving CDFA oversight of devices and moving quality products to market faster. The agency also released a regulation to strengthen technical reviews at provincial FDAs and increase communication between regulatory staff, industry and academic and healthcare experts.
And a new regulation on random inspections spells out the CFDA’s audit procedures and principals. According to Juliet Zhu, with L.E.K. Consulting in Shanghai, the inspections document, which provides details on sampling, procedure, reporting and reinspection, should give the agency “a stronger hand on device quality.” Wong says device companies would be wise to conduct internal audits in advance of a CFDA inspection. The CFDA expects to finalize revisions to its main medical device regulation by mid-December and put them in place by next summer, Wong tells IMDRM. According to Zhu, the reforms hew to targets set at a national device regulation management conference in February. Among other impending changes are:
- Manufacturers of Class I devices will be able to notify the agency, rather than go through the lengthier registration process; and
- Device makers will have to pay a fee for registration submissions.
REFERENCE: Meg Bryant; FDA News; International Medical Device Regulatory Monitor; November 2013; Vol. 21; No. 11