On June 1, 2014, the newly revised Medical Device Supervision and Administration Regulations (revised MDR) took effect. The revised MDR has changed medical device regulation in China significantly (described here), but some of the revised provisions conflict with implementing rules for the prior MDR that are still legally effective. Although the China Food and Drug Administration (CFDA) has released proposed revised drafts of many of these implementing rules, none have been finalized. Approximately one week prior to the effective date of the revised MDR, CFDA released a Notice on Issues Related to the Implementation of the MDR (Notice) which is intended to resolve some of these conflicts.
The Notice clarifies three issues. First, for most aspects of medical device registration, manufacturers should rely on “currently effective provisions” until the new rules are finalized and go into effect. The Notice also articulates that medical device registrations issued after June 1, 2014, will now have a five year license term, which the revised MDR expanded from the original 4 years.
Second, device manufacturers and distributors of class II and III devices should continue to rely on the current “administrative rules and guidance documents” for their operations, pending new rules. This clarification appears to mean, for example, that some class II device distributors will still need to obtain a distribution license. The revised MDR requires that distributors of class II devices undergo only notification procedures with local authorities and exempts them from holding a distribution license. However, the new draft implementing rules on device distribution have not yet been finalized. The device distribution rules still in effect now do not contain this broad exemption from licensure requirements for class II device distributors. Under the current rules, the class II device must be on a list before a distributor will be exempt from licensure requirements.
Third, for illegal conduct taking place before June 1, 2014, the prior MDR and its provisions on penalties will apply. However, the Notice grants an important exception if the conduct is no longer illegal or carries a lighter punishment under the revised MDR. In that case, the provisions of the revised MDR will apply. For all illegal conduct occurring after June 1, 2014, the provisions of the revised MDR will apply.
The Notice has clarified some of the other issues that may arise with the implementation of the revised MDR. Therefore, medical device manufacturers and distributors doing business in China should carefully consider the guidance provided by the Notice to assure compliance with the applicable MDR requirements. We will continue to monitor for the final versions of new implementing rules.