The director shall not determine a device to be beneficial or efficacious if any of the following exists:

Every manufacturer of, importer of, vender of, or dealer in, any device, except a dealer or agent that sells a registered device, shall obtain a certificate of device registration from the director before the device is manufactured for sale, advertised, delivered or otherwise provided, offered for sale or lease, sold, leased, possessed, or used, in this state, unless the device is used under a valid device research permit pursuant to Section 15314.

Each applicant for registration of a device, at a minimum, shall submit all of the following:

Within a timely manner after receipt of the information and fee specified in Section 15308, the director shall do one or more of the following:

If an applicant for registration of a device complies with this chapter and the regulations that are adopted pursuant to this chapter, the director shall register the device and issue a certificate of device registration to the applicant authorizing the manufacture and sale of the device in this state.

If the director finds that registration must be denied due to noncompliance with this chapter or the regulations that are adopted pursuant to this chapter, the director shall deny registration. Upon the request of the applicant, the director may hold a hearing to reconsider the director’s decision to deny the application.

Each applicant for a certificate of device registration shall inform the director of every brand and trademark of a device that the applicant intends to manufacture for sale, advertise, deliver or otherwise provide, offer for sale or lease, sell, lease, possess, or use. The director may require an applicant to identify each component in the device.

The registrant of a device shall immediately notify the director of any proposed change to the device including, but not limited to, labeling composition, configuration method of application, and use of the device. The director shall determine whether the changes require the director’s approval before the changed device may be manufactured for sale, advertised, delivered or otherwise provided, offered for sale or lease, sold, leased, possessed, or used in this state. The director shall notify the registrant of this determination.

The director may issue a device research permit for the scientific evaluation of new devices for a limited period of time determined by the director.

If, during the registration process, or at any time after the registration of a device, the applicant or registrant has factual or scientific information showing any adverse effect or risk of the device to human health or safety, property, or the environment that has not been previously submitted to the director, the applicant for registration or the registrant, as the case may be, shall immediately submit the information to the director.

If the director has reason to believe that any of the conditions stated in Section 15315 are applicable to any registered device and that the use or continued use of the device constitutes an immediate substantial danger to human health or safety, property, or the environment, the director, after notice to the registrant, may suspend the registration of that device pending a hearing and final decision. If the director does not file an accusation pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code within 30 days from the date of the suspension, the suspension shall be terminated.

The director may cancel a certificate of device registration, or refuse to issue a certificate of device registration to any manufacturer, importer, or dealer in any device that repeatedly violates this chapter or the regulations of the director.

Action by the director pursuant to Section 15305, 15311, 15315, 15317, or 15318 is not a condition precedent to the institution of any action to prosecute or levy a civil penalty for a violation of this chapter or regulations adopted pursuant to this chapter.