-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
In order to strengthen the registration management of drug-device combination products, according to the relevant regulations on the registration and management of drugs and medical devices, the registration of drug-device combination products is hereby notified as follows:
1.
A combination of medicine and equipment refers to a medical product that is composed of medicines and medical equipment and is produced as a single entity
.
A combination of medicine and equipment refers to a medical product that is composed of medicines and medical equipment and is produced as a single entity
.
2.
Drug-device combination products that focus on the role of drugs should be registered in accordance with the relevant requirements for drugs; drug-device combination products that focus on the role of medical devices should be filed and registered in accordance with the relevant requirements for medical devices
.
For the medicines or medical devices contained in the drug-device combination product that have been approved for marketing by China or the country of production (region), the corresponding marketing certification documents shall be submitted at the time of application for registration
.
Please refer to the relevant documents and guiding principles for the application materials requirements of drug-device combination products
.
Drug-device combination products that focus on the role of drugs should be registered in accordance with the relevant requirements for drugs; drug-device combination products that focus on the role of medical devices should be filed and registered in accordance with the relevant requirements for medical devices
.
For the medicines or medical devices contained in the drug-device combination product that have been approved for marketing by China or the country of production (region), the corresponding marketing certification documents shall be submitted at the time of application for registration
.
Please refer to the relevant documents and guiding principles for the application materials requirements of drug-device combination products
.
3.
The applicant should fully evaluate the attributes of the drug-device combination product it intends to declare
.
For drug-device combination products where the management attributes cannot be determined, the applicant shall apply to the Medical Device Standards Management Center of the State Drug Administration (hereinafter referred to as the Standard Management Center) for the definition of the drug-device combination products before applying for registration
.
The applicant should fully evaluate the attributes of the drug-device combination product it intends to declare
.
For drug-device combination products where the management attributes cannot be determined, the applicant shall apply to the Medical Device Standards Management Center of the State Drug Administration (hereinafter referred to as the Standard Management Center) for the definition of the drug-device combination products before applying for registration
.
4.
The Standards Management Center reviews the accepted application materials for the attribute definition of the drug-device combination product, proposes attribute definition opinions according to the procedures, informs the applicant in the drug-device combination product attribute definition information system, and promptly publicizes the drug-device combination product attribute definition on its website Result
.
The Standards Management Center reviews the accepted application materials for the attribute definition of the drug-device combination product, proposes attribute definition opinions according to the procedures, informs the applicant in the drug-device combination product attribute definition information system, and promptly publicizes the drug-device combination product attribute definition on its website Result
.
5.
The applicant shall apply to the State Drug Administration for registration of drugs or medical devices according to the result of product attribute definition, and indicate "medicine and device combination products" in the application form
.
The applicant shall apply to the State Drug Administration for registration of drugs or medical devices according to the result of product attribute definition, and indicate "medicine and device combination products" in the application form
.
6.
Establish a coordination mechanism between the Drug Evaluation Center of the State Drug Administration and the Medical Device Technology Evaluation Center
.
The drug-device combination products registered in accordance with the drug application shall be reviewed by the Drug Evaluation Center.
If joint review is required, the registration application materials shall be forwarded to the Medical Device Technology Review Center for simultaneous review; the drug-device combination products declared in accordance with the medical device registration shall be reviewed.
The review is led by the Medical Device Technology Review Center.
If a joint review is required, the registration application materials shall be forwarded to the Drug Review Center for simultaneous review
.
For joint-reviewed drug-device combination products, the drug review center and the medical device technical review center shall coordinate the communication and consultation of the declared products; both parties shall issue reviews on the safety, effectiveness, and quality controllability of the corresponding parts.
Report and clarify the review conclusions.
The lead unit will summarize and make an overall evaluation.
After the overall review conclusion is issued, it will be transferred to the corresponding business department of the State Drug Administration for administrative approval
.
Establish a coordination mechanism between the Drug Evaluation Center of the State Drug Administration and the Medical Device Technology Evaluation Center
.
The drug-device combination products registered in accordance with the drug application shall be reviewed by the Drug Evaluation Center.
If joint review is required, the registration application materials shall be forwarded to the Medical Device Technology Review Center for simultaneous review; the drug-device combination products declared in accordance with the medical device registration shall be reviewed.
The review is led by the Medical Device Technology Review Center.
If a joint review is required, the registration application materials shall be forwarded to the Drug Review Center for simultaneous review
.
For joint-reviewed drug-device combination products, the drug review center and the medical device technical review center shall coordinate the communication and consultation of the declared products; both parties shall issue reviews on the safety, effectiveness, and quality controllability of the corresponding parts.
Report and clarify the review conclusions.
The lead unit will summarize and make an overall evaluation.
After the overall review conclusion is issued, it will be transferred to the corresponding business department of the State Drug Administration for administrative approval
.
7.
If there are clear management attributes in relevant regulations and documents, they shall be implemented in accordance with the regulations
.
If there are clear management attributes in relevant regulations and documents, they shall be implemented in accordance with the regulations
.
8.
This notice will be implemented from the date of issuance, the "Notice on Matters Concerning the Registration of Medicine and Device Combination Products" (formerly the State Food and Drug Administration Announcement No.
16 of 2009) and the "Notice on Regulating Matters Concerning the Definition of the Attributes of Medicine and Device Combination Products" 》(Announcement No.
28 of 2019 of the State Drug Administration) shall be repealed at the same time
.
This notice will be implemented from the date of issuance, the "Notice on Matters Concerning the Registration of Medicine and Device Combination Products" (formerly the State Food and Drug Administration Announcement No.
16 of 2009) and the "Notice on Regulating Matters Concerning the Definition of the Attributes of Medicine and Device Combination Products" 》(Announcement No.
28 of 2019 of the State Drug Administration) shall be repealed at the same time
.
Hereby inform
.
.
Appendix:
1.
Procedures for defining the attributes of drug-device combination products
Procedures for defining the attributes of drug-device combination products
2.
Requirements and descriptions of application materials for attribute definition of drug-device combination products
Requirements and descriptions of application materials for attribute definition of drug-device combination products
State Food and Drug Administration
July 23, 2021
In order to strengthen the registration management of drug-device combination products, according to the relevant regulations on the registration and management of drugs and medical devices, the registration of drug-device combination products is hereby notified as follows:
1.
A combination of medicine and equipment refers to a medical product that is composed of medicines and medical equipment and is produced as a single entity
.
A combination of medicine and equipment refers to a medical product that is composed of medicines and medical equipment and is produced as a single entity
.
2.
Drug-device combination products that focus on the role of drugs should be registered in accordance with the relevant requirements for drugs; drug-device combination products that focus on the role of medical devices should be filed and registered in accordance with the relevant requirements for medical devices
.
For the medicines or medical devices contained in the drug-device combination product that have been approved for marketing by China or the country of production (region), the corresponding marketing certification documents shall be submitted at the time of application for registration
.
Please refer to the relevant documents and guiding principles for the application materials requirements of drug-device combination products
.
Drug-device combination products that focus on the role of drugs should be registered in accordance with the relevant requirements for drugs; drug-device combination products that focus on the role of medical devices should be filed and registered in accordance with the relevant requirements for medical devices
.
For the medicines or medical devices contained in the drug-device combination product that have been approved for marketing by China or the country of production (region), the corresponding marketing certification documents shall be submitted at the time of application for registration
.
Please refer to the relevant documents and guiding principles for the application materials requirements of drug-device combination products
.
3.
The applicant should fully evaluate the attributes of the drug-device combination product it intends to declare
.
For drug-device combination products where the management attributes cannot be determined, the applicant shall apply to the Medical Device Standards Management Center of the State Drug Administration (hereinafter referred to as the Standard Management Center) for the definition of the drug-device combination products before applying for registration
.
The applicant should fully evaluate the attributes of the drug-device combination product it intends to declare
.
For drug-device combination products where the management attributes cannot be determined, the applicant shall apply to the Medical Device Standards Management Center of the State Drug Administration (hereinafter referred to as the Standard Management Center) for the definition of the drug-device combination products before applying for registration
.
4.
The Standards Management Center reviews the accepted application materials for the attribute definition of the drug-device combination product, proposes attribute definition opinions according to the procedures, informs the applicant in the drug-device combination product attribute definition information system, and promptly publicizes the drug-device combination product attribute definition on its website Result
.
The Standards Management Center reviews the accepted application materials for the attribute definition of the drug-device combination product, proposes attribute definition opinions according to the procedures, informs the applicant in the drug-device combination product attribute definition information system, and promptly publicizes the drug-device combination product attribute definition on its website Result
.
5.
The applicant shall apply to the State Drug Administration for registration of drugs or medical devices according to the result of product attribute definition, and indicate "medicine and device combination products" in the application form
.
The applicant shall apply to the State Drug Administration for registration of drugs or medical devices according to the result of product attribute definition, and indicate "medicine and device combination products" in the application form
.
6.
Establish a coordination mechanism between the Drug Evaluation Center of the State Drug Administration and the Medical Device Technology Evaluation Center
.
The drug-device combination products registered in accordance with the drug application shall be reviewed by the Drug Evaluation Center.
If joint review is required, the registration application materials shall be forwarded to the Medical Device Technology Review Center for simultaneous review; the drug-device combination products declared in accordance with the medical device registration shall be reviewed.
The review is led by the Medical Device Technology Review Center.
If a joint review is required, the registration application materials shall be forwarded to the Drug Review Center for simultaneous review
.
For joint-reviewed drug-device combination products, the drug review center and the medical device technical review center shall coordinate the communication and consultation of the declared products; both parties shall issue reviews on the safety, effectiveness, and quality controllability of the corresponding parts.
Report and clarify the review conclusions.
The lead unit will summarize and make an overall evaluation.
After the overall review conclusion is issued, it will be transferred to the corresponding business department of the State Drug Administration for administrative approval
.
Establish a coordination mechanism between the Drug Evaluation Center of the State Drug Administration and the Medical Device Technology Evaluation Center
.
The drug-device combination products registered in accordance with the drug application shall be reviewed by the Drug Evaluation Center.
If joint review is required, the registration application materials shall be forwarded to the Medical Device Technology Review Center for simultaneous review; the drug-device combination products declared in accordance with the medical device registration shall be reviewed.
The review is led by the Medical Device Technology Review Center.
If a joint review is required, the registration application materials shall be forwarded to the Drug Review Center for simultaneous review
.
For joint-reviewed drug-device combination products, the drug review center and the medical device technical review center shall coordinate the communication and consultation of the declared products; both parties shall issue reviews on the safety, effectiveness, and quality controllability of the corresponding parts.
Report and clarify the review conclusions.
The lead unit will summarize and make an overall evaluation.
After the overall review conclusion is issued, it will be transferred to the corresponding business department of the State Drug Administration for administrative approval
.
7.
If there are clear management attributes in relevant regulations and documents, they shall be implemented in accordance with the regulations
.
If there are clear management attributes in relevant regulations and documents, they shall be implemented in accordance with the regulations
.
8.
This notice will be implemented from the date of issuance, the "Notice on Matters Concerning the Registration of Medicine and Device Combination Products" (formerly the State Food and Drug Administration Announcement No.
16 of 2009) and the "Notice on Regulating Matters Concerning the Definition of the Attributes of Medicine and Device Combination Products" 》(Announcement No.
28 of 2019 of the State Drug Administration) shall be repealed at the same time
.
This notice will be implemented from the date of issuance, the "Notice on Matters Concerning the Registration of Medicine and Device Combination Products" (formerly the State Food and Drug Administration Announcement No.
16 of 2009) and the "Notice on Regulating Matters Concerning the Definition of the Attributes of Medicine and Device Combination Products" 》(Announcement No.
28 of 2019 of the State Drug Administration) shall be repealed at the same time
.
Hereby inform
.
.
Appendix:
1.
Procedures for defining the attributes of drug-device combination products
Procedures for defining the attributes of drug-device combination products
2.
Requirements and descriptions of application materials for attribute definition of drug-device combination products
Requirements and descriptions of application materials for attribute definition of drug-device combination products
State Food and Drug Administration
July 23, 2021
In order to strengthen the registration management of drug-device combination products, according to the relevant regulations on the registration and management of drugs and medical devices, the registration of drug-device combination products is hereby notified as follows:
1.
A combination of medicine and equipment refers to a medical product that is composed of medicines and medical equipment and is produced as a single entity
.
A combination of medicine and equipment refers to a medical product that is composed of medicines and medical equipment and is produced as a single entity
.
2.
Drug-device combination products that focus on the role of drugs should be registered in accordance with the relevant requirements for drugs; drug-device combination products that focus on the role of medical devices should be filed and registered in accordance with the relevant requirements for medical devices
.
For the medicines or medical devices contained in the drug-device combination product that have been approved for marketing by China or the country of production (region), the corresponding marketing certification documents shall be submitted at the time of application for registration
.
Please refer to the relevant documents and guiding principles for the application materials requirements of drug-device combination products
.
Drug-device combination products that focus on the role of drugs should be registered in accordance with the relevant requirements for drugs; drug-device combination products that focus on the role of medical devices should be filed and registered in accordance with the relevant requirements for medical devices
.
For the medicines or medical devices contained in the drug-device combination product that have been approved for marketing by China or the country of production (region), the corresponding marketing certification documents shall be submitted at the time of application for registration
.
Please refer to the relevant documents and guiding principles for the application materials requirements of drug-device combination products
.
3.
The applicant should fully evaluate the attributes of the drug-device combination product it intends to declare
.
For drug-device combination products where the management attributes cannot be determined, the applicant shall apply to the Medical Device Standards Management Center of the State Drug Administration (hereinafter referred to as the Standard Management Center) for the definition of the drug-device combination products before applying for registration
.
Standard Standard StandardThe applicant should fully evaluate the attributes of the drug-device combination product it intends to declare
.
For drug-device combination products where the management attributes cannot be determined, the applicant shall apply to the Medical Device Standards Management Center of the State Drug Administration (hereinafter referred to as the Standard Management Center) for the definition of the drug-device combination products before applying for registration
.
4.
The Standards Management Center reviews the accepted application materials for the attribute definition of the drug-device combination product, proposes attribute definition opinions according to the procedures, informs the applicant in the drug-device combination product attribute definition information system, and promptly publicizes the drug-device combination product attribute definition on its website Result
.
The Standards Management Center reviews the accepted application materials for the attribute definition of the drug-device combination product, proposes attribute definition opinions according to the procedures, informs the applicant in the drug-device combination product attribute definition information system, and promptly publicizes the drug-device combination product attribute definition on its website Result
.
5.
The applicant shall apply to the State Drug Administration for registration of drugs or medical devices according to the result of product attribute definition, and indicate "medicine and device combination products" in the application form
.
The applicant shall apply to the State Drug Administration for registration of drugs or medical devices according to the result of product attribute definition, and indicate "medicine and device combination products" in the application form
.
6.
Establish a coordination mechanism between the Drug Evaluation Center of the State Drug Administration and the Medical Device Technology Evaluation Center
.
The drug-device combination products registered in accordance with the drug application shall be reviewed by the Drug Evaluation Center.
If joint review is required, the registration application materials shall be forwarded to the Medical Device Technology Review Center for simultaneous review; the drug-device combination products declared in accordance with the medical device registration shall be reviewed.
The review is led by the Medical Device Technology Review Center.
If a joint review is required, the registration application materials shall be forwarded to the Drug Review Center for simultaneous review
.
For joint-reviewed drug-device combination products, the drug review center and the medical device technical review center shall coordinate the communication and consultation of the declared products; both parties shall issue reviews on the safety, effectiveness, and quality controllability of the corresponding parts.
Report and clarify the review conclusions.
The lead unit will summarize and make an overall evaluation.
After the overall review conclusion is issued, it will be transferred to the corresponding business department of the State Drug Administration for administrative approval
.
Medicines Medicines Medicines Medical Devices Medical Devices Medical DevicesEstablish a coordination mechanism between the Drug Evaluation Center of the State Drug Administration and the Medical Device Technology Evaluation Center
.
The drug-device combination products registered in accordance with the drug application shall be reviewed by the Drug Evaluation Center.
If joint review is required, the registration application materials shall be forwarded to the Medical Device Technology Review Center for simultaneous review; the drug-device combination products declared in accordance with the medical device registration shall be reviewed.
The review is led by the Medical Device Technology Review Center.
If a joint review is required, the registration application materials shall be forwarded to the Drug Review Center for simultaneous review
.
For joint-reviewed drug-device combination products, the drug review center and the medical device technical review center shall coordinate the communication and consultation of the declared products; both parties shall issue reviews on the safety, effectiveness, and quality controllability of the corresponding parts.
Report and clarify the review conclusions.
The lead unit will summarize and make an overall evaluation.
After the overall review conclusion is issued, it will be transferred to the corresponding business department of the State Drug Administration for administrative approval
.
7.
If there are clear management attributes in relevant regulations and documents, they shall be implemented in accordance with the regulations
.
Regulations and regulationsIf there are clear management attributes in relevant regulations and documents, they shall be implemented in accordance with the regulations
.
8.
This notice will be implemented from the date of issuance, the "Notice on Matters Concerning the Registration of Medicine and Device Combination Products" (formerly the State Food and Drug Administration Announcement No.
16 of 2009) and the "Notice on Regulating Matters Concerning the Definition of the Attributes of Medicine and Device Combination Products" 》(Announcement No.
28 of 2019 of the State Drug Administration) shall be repealed at the same time
.
This notice will be implemented from the date of issuance, the "Notice on Matters Concerning the Registration of Medicine and Device Combination Products" (formerly the State Food and Drug Administration Announcement No.
16 of 2009) and the "Notice on Regulating Matters Concerning the Definition of the Attributes of Medicine and Device Combination Products" 》(Announcement No.
28 of 2019 of the State Drug Administration) shall be repealed at the same time
.
Hereby inform
.
.
Appendix:
Appendix: 1.
Procedures for defining the attributes of drug-device combination products
Procedures for defining the attributes of drug-device combination products
2.
Requirements and descriptions of application materials for attribute definition of drug-device combination products
Requirements and descriptions of application materials for attribute definition of drug-device combination products
State Food and Drug Administration
July 23, 2021
