Global Regulatory Pulse

CFDA Releases “Amendments to the Regulations on the Supervision and Administration of Medical Devices” Exposure Draft

In Asian Market, Regulatory by Yufei Bai0 Comments

On October 31, 2017, the China Food and Drug Administration (CFDA) issued the “Amendments to the Regulations on the Supervision and Administration of Medical Devices” Exposure Draft which aims to strengthen medical device technology reviews and approval systems. This draft guidance also further encourages medical technology innovation in light of the original guidance on “Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices”, issued by the State Council on October 8, 2017.

Though this amendment is still in draft form, there are several parallels between the original guidance and the updated exposure draft. However, of particular importance for foreign and domestic medical product manufacturers, as well as domestic legal agents, are three significant areas of change, which include:

  1. New qualified conditions and specific obligations for registrants or record filing applicants of medical devices. These stakeholders may independently produce or sell medical devices or entrust qualified manufacturers of medical devices to produce or sell devices if they meet the provisions within the amended regulations.
  2. For innovative medical devices that are not marketed domestically or abroad, the applicant may be exempt from submitting proof that indicates the medical device under application is allowed to be sold on the market. This process is managed by the competent departments of the country (region) at the domicile of the registration applicant.
    1. For a Class II or III medical devices, the inclusion of testing reports within the registration application may satisfy the requirement of self-inspection reports. These may be produced by the manufacturer, or by the manufacturer’s entrusted qualified medical device testing agency.
  3. Foreign clinical data may be used to meet medical device registration requirements if the data meets all relevant criteria.

Below is a breakdown of the most noteworthy amendments for further consideration by foreign and domestic medical product manufacturers and domestic legal agents.

Article No.  Article 9
Amendment The registrants or record filing applicants of medical devices who wish to market products in their own name shall have the appropriate abilities in quality management, risk prevention, continuous research and liability compensation; shall ensure that study documents and clinical trial data submitted are true, complete and traceable; and shall bear legal responsibility for the full life cycle of medical devices.

The registrants or record filing applicants of medical devices shall fulfill the following obligations:

  • Establish a quality management system (QMS) compatible with the product and maintain the effective operation of the QMS, regularly perform self-tests for the QMS and submit self-inspection reports to the food and drug administration.
  • Develop continuous post-marketing research and risk control plan, and ensure effective implementation of the plan.
  • Carry out adverse event (AE) monitoring and reevaluation according to law.
  • Establish a product traceability and recall system, and maintain effective operation of the system.
  • Fulfill other obligations stipulated by the CFDA of the State Council.
Comments The conditions, responsibilities and obligations for registrants or record filing applicants of medical devices and their appointed domestic legal agents are clarified further. What’s more, the legal agents of an overseas registrant or record filing applicant of a medical device shall apply for record filing of agent information with the CFDA, an autonomous region or municipality directly under the central government at the domicile of the agent.

 

Article No.  Article 10
Amendment Overseas registrants or record filing applicants of a medical device shall appoint a representative office established within Mainland China, or designate a domestic enterprise legal contact with abilities in quality management, risk prevention and liability compensation to serve as a manufacturer’s agent.

The agent of an overseas registrant or record filing applicant of a medical device shall fulfill the following obligations:

  • Apply for medical device registration or a record filing in accordance with the provisions of the regulations, and act as a bridge between the CFDA and the overseas registrant or record filing applicant.
  • Promptly inform the overseas registrant or record filing applicant of the related laws, regulations and technical requirements, and urge implementation of the laws, regulations and technical requirements.
  • Undertake AE monitoring for the imported medical devices marketed in China, and promptly report AEs of the imported medical devices in foreign countries to the CFDA.
  • Cooperate in any recalls of a medical device after marketing, and report a product recall to the CFDA.
  • Assist the CFDA in the inspection of the overseas registrant or record filing applicant, and investigation and punishment of any illegal act.
  • Jointly assume legal responsibility for any illegal act related to product quality and service with the overseas registrant or record filing applicant.

The agent of an overseas registrant or record filing applicant of a medical device shall apply for agent information through the CFDA’s people’s government of the province, autonomous region or municipality directly under the Central Government at the domicile of the agent.

Comments The conditions, responsibilities and obligations for registrants or record filing applicants of medical devices and their appointed domestic legal agents are clarified further. What’s more, the legal agents of an overseas registrant or record filing applicant of a medical device shall apply for record filing of agent information with the CFDA, an autonomous region or municipality directly under the central government at the domicile of the agent.

 

Article No.  Article 11 
Amendment Registrants or record filing applicants of medical devices may independently produce or sell medical devices, or entrust manufacturers or business operators of medical devices that meet the provisions in the regulations and have the appropriate conditions to produce or sell medical devices. If registrants of medical devices entrust manufacturers or business operators to produce or sell medical devices, the registrants shall sign an agreement with the entrusted manufacturers or business operators to specify the rights, obligations and responsibilities of both parties, and ensure that the production and operation of the entrusted party meet the requirements in the regulations.

“The enterprises, organizations and individuals who are entrusted with research and development, clinical trials, production or operation of medical devices by registrants or record filing applicants of medical devices shall bear the responsibilities stipulated in the laws, regulations and agreements.”

Comments The intent of this exposure draft is to also improve the Marketing Authorization Holder (MAH) system. Registrants or record filing applicants of medical devices are now able to entrust manufacturers or business operators of medical devices that meet the provisions in the regulations to produce or sell medical devices.

 

Article No.  Article 14 
Amendment New language added (second paragraph amendment):
“An overseas registration applicant that exports Class II or III medical devices to Mainland China shall assign its agent within Mainland China to submit to the CFDA of the State Council the registration application materials and the proofs issued by the competent departments of the country (region) at the domicile of the registration applicant that the medical device under application is allowed to be sold on the market. For innovative medical devices that are not marketed at home or abroad, the applicant may be exempted from submitting the proof issued by the competent departments of the country (region) at the domicile of the registration applicant that the medical device under application is allowed to be sold on the market.”New language added (third paragraph amendment):
“Product testing reports in the registration application materials for a Class II or III medical device product may be the self-inspection reports of the registration applicant, or the testing reports issued by the entrusted qualified medical device testing agencies.”
Comments  The specific requirements of the self-inspection testing reports or the entrusted ones in the process of registration application for a Class II or III medical device are unaware in the amendment. Neither are the definitions or conditions of a qualified testing institution. To some extent, it demonstrates that the requirements of testing reports categories or testing institutions become looser but we shall realize that the quality level of testing reports would not reduce.

 

Article No.  Article 20 
Amendment New language added: “Foreign clinical data may be used for application for registration in China if the data meets the relevant requirements for medical device registration in China.”
Comments N/A


How Can NAMSA Help?
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Some services available, include:

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Authors:

Yufei Bai serves as a regulatory consulting assistant for NAMSA-China. He has experience working with the China Food & Drug Administration (CFDA) and providing registration support to global medical device manufacturers on behalf of NAMSA. Yufei holds a Bachelors Degree in Economics and English from Beijing International Studies University.

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