How to apply for a CA (Certification Authority) certificate in eRPS

On May 31, 2019, the NMPA issued the "Notice on the Implementation of Electronic Declaration of Medical Device Registration (eRPS) (No. 46 of 2019)", which was officially implemented on June 24, 2019. This is the biggest change in medical device registration this year. At present, the eRPS system has been officially implemented for nearly 4 months, and the registration materials submitted to the NMPA from next month need to be submitted in accordance with the requirements of the electronic filing catalogue (including the paper version).

In the case of electronic filing, medical device companies must first apply for a CA certificate of eRPS, otherwise they can only report offline. This article mainly introduces the relevant regulatory requirements and precautions for CA certificate application.

I. Why do we need to apply for a CA certificate?

The CA certificate is the identity certificate and electronic signature of the user to log in and upload the data when apply in the eRPS, and has the same legal effect as the handwritten signature and the official seal.

After receiving the CA certificate, the medical device enterprise must insert the CA certificate to log in the web version of the eRPS system, otherwise it will not be able to log in and when using the App, the signature cannot be made and the data cannot be submitted.

Therefore, no electronic declaration is possible without a CA.

II. What kind of business needs to apply for a CA certificate

According to the “Notice on the Application for CA Certificate of eRPS System” issued by the CMDE, the CA certificate applicant/holder shall be the Class III medical device applicant/registration in China or an agent of imported medical device manufacturer. Each medical device enterprise is limited to apply for one CA certificate with signature function.

This is mainly related to the current scope of application of eRPS. eRPS's business scope includes domestic Class III and imported Class II，Class III medical device registration, registration alteration, continuation registration, Class III high-risk medical device clinical trial approval, and medical device manual alteration notification, Medical device registration and licensing alteration review, special review of innovative medical devices, etc. In addition, there are also temporary suspensions including designated inspections, corrections, and withdrawals.

In summary, the Class III medical device manufacturers and import product agents need to apply for CA certificate.

III. How to apply for the CA certificate

Since May 10, 2019, the NMPA has opened the channel for CA applications. Medical device enterprises can apply for CA certificate at the eRPS website (https://erps.cmde.org.cn/) or through the applicant's window column of the CMDE or the registration management information system of the NMPA.

First, the enterprise needs to register an account. The enterprise that has already registered the management system account needs to re-register. After the account is registered and logged in, the CA certificate can be applied by entering the declaration page. The CA application must first submit the electronic version of the application materials online, and the time for receiving the CA can be reserved in the system after the acceptance and the verification. Please note that the on-site application time has only one modification opportunity, and must be received on the spot by the CA administrator designated by the materials.

IV. Application materials for CA certificate

The CA application materials consist of online submissions and on-site application materials.

Note:

1. The online application materials have requirements for the size, format and resolution of the scanned documents;

2. The agent's letter of authorization (original) could be the notarized documents issued by the importing medical device enterprise within 2 years;

3. Other information should be filled in according to the template provided by the system;

4. CA application needs to review the applicant's business scope. If the scope of the domestic medical device enterprise does not include the Class III medical device production, it cannot be declared (except as an agent). If the domestic medical device enterprise is developing Class III products, then they can check whether they can change the business scope according to local regulations, or provide test reports signed with the test center to prove that the enterprise wants to declare the Class III product registration.