New announcement focus

1.The new filing materials are required to be written in more detail,If the product has microbial limit requirements,It is necessary to specify what measures are taken to make the products comply with the regulations.After filing,The supervision department shall focus on reviewing the authenticity of the recorded materials,It is not only to check whether the site meets the requirements.According to the new announcement,After filing,One more Notification of filing number of class I medical devices .

2.If the product needs to be sterilized or disinfected by the user according to the instructions before use,Corresponding verification report shall be provided when filing.In the past, this kind of situation was encountered only when the classification was defined,Required by the National Bureau.Now, as long as the recorded products involve the above situations,Enterprises are required to provide verification reports.

3.If the category of the previously recorded products is adjusted to category II or III,It is necessary to cancel the filing actively,Apply for registration.If some products are no longer managed as medical devices,It shall also take the initiative to cancel the filing,If you don't take the initiative,The filing department may directly announce the invalidation of the Filing Certificate.

4.The new announcement particularly stresses that enterprises that provide false information should be punished,Serious,In addition to fines,Relevant person in charge5This industry is prohibited during the year.

Announcement of the State Food and Drug Administration on matters related to the filing of class I medical devices(2022Year62number)

      In order to do a good job in the filing of class I medical devices,according to Regulations on the supervision and administration of medical devices Order of the State Council No739number Administrative measures for registration and filing of medical devices Order of the State Administration of market supervision No47number Administrative measures for registration and filing of in vitro diagnostic reagents Order of the State Administration of market supervision No48number ,For the first category of medical devices Including class I in vitro diagnostic reagents Relevant matters for filing are announced as follows:

one Medical device filing refers to the person who files the medical device (hereinafter referred to as the recorder) Submit the filing materials to the drug regulatory department in accordance with the legal procedures and requirements,Activities of the drug regulatory department for filing the submitted filing materials for future reference.

two Domestic class I medical device filing,The filing person shall submit the filing materials to the drug supervision and administration department at the municipal level divided into districts.Filing of imported class I medical devices,The filing person shall submit the filing materials to the State Drug Administration.

three When determining the product management category,It shall be combined with the actual situation of the product,according to Category I medical device product catalog Subcategory of in vitro diagnostic reagents Product description in the regulations The intended use and product name shall be judged by examples.

according to Category I medical device product catalog Subcategory of in vitro diagnostic reagents (hereinafter referred to as the "Catalogue") And the results of relevant classification and definition, etc. are determined to be class I medical devices,The filing person shall handle the filing with the corresponding filing department Beyond the contents of the directory,Apply for classification and definition according to relevant work procedures,Clearly classified as class I medical devices,File with the corresponding filing department.

four Handle medical device filing,The recorders shall submit the documents that meet the requirements (see attachment)1 Filing materials of,Fill in the filing form (see attachment)2 ,Obtain record number.The recorders shall ensure that the materials submitted are legal real accuracy Complete and traceable.

five The filing person submits the following documents:1The filing shall be completed after the required filing materials.For the filed medical devices,The filing department shall provide the filing number to the filing person s%s3 ,s%s s%s s%s s%s s%s4 s%s.

s%s s%s,s%s,s%s,s%s.s%s,s%s s%s s%s,s%s.

s%s s%s s%s5 s%s.

s%s s%s

×1s%s××××2××××3.s%s

×1s%s

s%s s%s s%s

s%s s%s s%s s%s,s%s s%s s%s

××××2s%s

××××3s%s.

s%s s%s,s%s s%s.s%s,s%s,s%s.

s%s,s%s,s%s,s%s.

s%s.s%s s%s 2014s%s26s%s s%s.

s%s.

s%s

1. s%s

2. s%s s%s

3. s%s

4. s%s

5. s%s

s%s

2022s%s8s%s10s%s

s%s1  s%s

s%s s%s

s%s s%s

s%s s%s

1．s%s s%s.

s%s,s%s s%s s%s.

2．s%s

1 s%s s%s s%s s%s s%s.

2 s%s s%s s%s.s%s s%s s%s,s%s,s%s s%s s%s.s%s s%s s%s.

3 s%s s%s,s%s.

s%s s%s

s%s s%s s%s,s%s s%s.

s%s s%s

s%s,s%s.

s%s.s%s,s%s.s%s,s%s.

s%s s%s

s%s s%s s%s s%s,s%s.s%s.

s%s s%s

s%s.s%s,s%s.s%s,s%s,s%s.s%s,s%s s%s s%s,s%s s%s s%s s%s s%s s%s s%s s%s.

s%s s%s,s%s s%s.

s%s,s%s s%s s%s.

s%s s%s

1. s%s

2. s%s,s%s s%s s%s s%s s%s,s%s,s%s s%s s%s

3. s%s s%s

4. s%s s%s,s%s .

s%s s%s

s%s s%s

s%s.

s%s,s%s s%s .

s%s s%s

s%s,s%s.

s%s s%s,s%s.

s%s s%s

1. s%s

2. s%s,s%s s%s s%s s%s s%s,s%s,s%s s%s s%s

3. s%s s%s

4. s%s s%s,s%s .

s%s s%s

s%s s%s s%s

s%s s%s s%s s%s s%s s%s s%s s%s,s%s s%s s%s19s%s s%s.

s%s s%s s%s s%s s%s s%s .

s%s s%s s%s

s%s s%s s%s s%s s%s s%s s%s s%s s%s,s%s s%s s%s s%s s%s.

s%s s%s s%s s%s s%s,s%s.s%s,s%s,s%s s%s,s%s s%s s%s ,s%s s%s s%s ,s%s.s%s s%s s%s s%s s%s s%s s%s s%s,s%s s%s s%s.

s%s s%s/s%s

s%s/s%s s%s.

s%s s%s s%s

s%s s%s.s%s s%s s%s.

s%s s%s s%s

s%s s%s s%s,s%s.

s%s s%s

s%s s%s s%s s%s s%s s%s s%s.

s%s,s%s.

s%s s%s

s%s s%s.s%s.

s%s s%s.s%s.s%s,s%s.

s%s s%s,s%s. s%s s%s s%s,s%s s%s.

s%s s%s,s%s,s%s.s%s s%s s%s s%s,s%s s%s s%s s%s s%s,s%s s%s.

s%s s%s s%s s%s.s%s,s%s.

s%s s%s,s%s,s%s,s%s.

s%s s%s

s%s s%s,s%s

1.s%s,s%s,s%s s%s s%s , s%s s%s s%s,s%s s%s s%s,s%s s%s s%s,s%s s%s s%s.

2.s%s,s%s,s%s s%s s%s , s%s s%s s%s s%s s%s s%s s%s,s%s s%s s%s .

s%s s%s s%s 09-02-03s%s 09-03-08s%s 14-10-02s%s 20-03-11s%s s%s,s%s s%s s%s s%s s%s s%s s%s,s%s s%s s%s.

s%s 09-02-03s%s s%s,s%s s%s s%s,s%s.

s%s s%s.s%s,s%s s%s ,s%s,s%s.s%s,s%s,s%s s%s s%s s%s s%s s%s,s%s s%s s%s s%s s%s.s%s, s%s s%s,s%s s%s s%s s%s ,s%s.s%s.

s%s