New progress in the Medical Registration System

On September 18, 2019, Mr. Zhang Xinghua, director of medical device Department of Jiangsu Provincial Food and Drug Administration, delivered a speech on "Analysis of current Medical Device Supervision Form" at the 10th China (Taizhou) International Pharmaceutical Expo, conveying many key developments about current medical device supervision.

Looking forward to! The new regulations are expected to be issued before the end of the year

The Ministry of Justice and the State Council held a meeting in Suzhou in early August to solicit opinions on the new regulations for the last time. The state Council will meet in September. The new regulations are expected to be issued by the end of the year. The main changes in the newly revised Regulations on The Supervision and Administration of Medical Devices include:

1. Improve the registration system: See the introduction of the registration system below for details.

2. Reform the management system of clinical trials

The concept of clinical evaluation, the principle of clinical evaluation and the rules of extended clinical trial were put forward.

3, the latest news: second - class review will still be responsible by the provincial bureau!

The ownership of the examination and approval of category II products has always been controversial, and it has gone through a process of "up and down" in the process of soliciting opinions on the amendment of regulations. Last week's update: provincial bureaus are still largely in charge.

4. Inspection of class II or Class III registration may be conducted by providing the self-inspection report of the enterprise or by entrusting qualified inspection institutions

5. Used for conditional examination and approval of medical devices for rare diseases

6. For some of the second-class medical devices that can be guaranteed safe through routine management, there is no need for operating record, such as thermometer and household blood glucose meter

7. Strengthen the supervision of medical devices that have been used

8. Add penalty to person clause. The penalties are heavier.

Update on the Registration System

1. The Yangtze River Delta jointly promotes the pilot work of medical device registration system

The scope of the pilot registration system has been expanded to 21 places, and heilongjiang, Zhejiang, Hebei, Fujian and Beijing have successively published draft implementation plans for the pilot work for comments.

From September 6 to 7, 2019, Shanghai Municipal Food and Drug Administration led a seminar on promoting the pilot work of medical device registration system in the Yangtze River Delta. The four provinces and cities will release the plan at the same time, which is expected to be released by the end of September.

There are some bright spots, such as for group holders, if the production address has not been changed, only the name of the holder has been changed, only to simplify the changes of registered items.

2. Breakthrough in the registration system pilot

A. Production can be commissioned across provinces.

B. It can be commissioned by more than one company

C. Samples can be produced by enterprises with production capacity. A medical device license is not required for a registered sample trustee.

D. It can be commissioned before registration or after obtaining evidence

E. The scientific research institution may act as the registrant. However, individuals may not be registered

F. Some high-risk medical devices shall not be commissioned for production

G. The registration system does not cover class I medical devices

3. Differences between the registrant system and the current commissioned production

A. Unbind production and registration. Before, registration certificate and production license were needed to entrust production

B. Different handling methods. The entrusted production enterprise may handle the production license with the registration certificate of the entrusting party

C. Different responsibilities. The legal responsibility for the entire product life cycle lies with the registrant. The quality management system and process of the entrusted enterprise must comply with the requirements of the registrant.

4. What responsibilities shall the registrant and the trustee bear respectively

Registrant: shall be responsible for the whole life cycle of the product and shall bear the corresponding legal liability for the design and development, clinical trial, manufacturing, sales and distribution, after-sales service, retrospective recall, adverse event report, reevaluation and other quality products of the whole life cycle of the medical device.

Agent: Mainly responsible for production activities. Basically, it can be understood that the registrant is responsible for all other responsibilities except that the registrant has no factory to produce and completes the production through the trustee.

5. Cross-regional supervision -- "The species belongs to human and the supervision belongs to local"

At present, a Shanghai enterprise has entrusted changzhou enterprise to produce. A few days ago, the system is being checked, and jiangsu Provincial Bureau is also involved. It is likely to be the first case of cross-provincial regulation.

At present, the consensus reached by the two sides can be summarized as "species belong to person, regulatory territory" :

Type belongs to person: the drug administration department where the registrant is located initiates the registration system verification, is the responsible party, ACTS as the group leader, and releases the verification results.

Supervision dependency: the local drug administration department of the agent shall conduct daily supervision and inspection of the agent.

6. Dividends released by the registrant system

A. It is the spring of scientific research enterprises. Research enterprises can find CRO,CDMO to do research and development, production.

B. It is also a good news for small and micro enterprises, group enterprises and enterprises with the need to expand production capacity or origin;

C. The way in which enterprises compete with each other may turn into cooperation

D. It is expected that the number of registrations will decline, which may lead to changes in the regulatory approach