CFDA interprets on How to Deal with Medical Device Standards Update

On Mar 2^nd, 2015, a lot of new mandatory standards have been issued and will be put into effect from Jan 1^st, 2017, and the old ones will be abolished by that time. The updated standards include YY 0572-2015 Water for heamodialysis and related therapies, YY 0598-2015 Concentrate for heamodialysis and related therapies, YY 0953-2015 Medical carboxymethyl chitosan, and so on.
Oct 4^th, 2015, CFDA issued a notice about Related Problems of Management Measures of Registration for Medical Device and In Vitro Diagnostic Reagent to help you respond to standards update.

1. CFDA Notice: Original text: Problems about review of medical device received before new mandatory standards implementation.

If the mandatory standards referenced in product technical requirements have been changed, but the product was received for registration review before the new mandatory standards implemented, in this case, the product will be inspected, reviewed and approved according to the old standards unless otherwise specified. Anyway, from the day of new standards implemented, enterprise shall manufacture your medical device according to the new standard.

Close reading of this explanation:

The key point of this explanation is point-in-time. There are different solutions in different situations.

Situation 1

During this period that new mandatory standards have been issued but not yet implemented, if your registration application has been received, so not matter whenever you summit your registration application, before or after mandatory standards implementation, the officer will inspect, review and approve according to old standards. And from the day of standards implementation, you shall manufacture your product according to the new standard. If the mandatory standards have been implemented, and your application is still in the situation of review and approval, you cannot submit the alteration application until your certificate has been issued. To know how to apply for the alteration application, please see here.

Situation 2

If you obtain registration certificate before the new mandatory standards complemented, you shall follow the new mandatory standard form its complementation data, and submit the alteration application.

2. CFDA Notice: Original text: Problem about Renewal of Registration involved with mandatory standard update

When you apply for renewing your registration certificate under the condition that your product without change but the manadatory standards are updated, then you shall modify your product technical requirements and other approval item in order to meet new mandatory standards, and also submit the inspection report which as well meet the new mandatory standards update.

Officer will review your product whether it conforms to new mandatory standards, if it conforms, officer will approve your renewal of certificate.

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.