Amendments of the Regulations on Supervision and
Management of Medical Devices (Draft)
Publish date: June 25, 2018 Source: Ministry of Justice of P. R. China
In order to deepen the reform of the review and approval system and encourage the
innovation of medical devices, the Regulations on Supervision and Management of Medical
Devices are revised as follows:
- For Article 8, three paragraphs are added, i.e., Paragraph 2, Paragraph 3 and Paragraph
4 as below. When applying for marketing medical devices, the applicant shall be filed by the
department in charge of drug supervision and administration or approved by the drug
administration department under the State Council. Those who have obtained the filing
approval or the registration certificate of medical devices shall be the owners of the marketing
license for medical devices. When the drug administration department under the State Council reviews the application
for approval, it shall review the safety and effectiveness of medical devices and the quality
management ability of the applicant to ensure the safety and effectiveness of medical devices. The drug administration department under the State Council may authorize the relevant
institutions satisfying the requirement after evaluation to conduct review and approval work. 2. For Article 9, Item 4 of Paragraph 1 is deleted. Two paragraphs are added as Paragraph 2 and Paragraph 3 as below. The product test report may be the self-test report of the applicant/filer or the test report
issued by a qualified medical device test institution.
If the to-be-registered Class II and Class III medical device products require clinical
evaluation, the applicant shall also submit the clinical evaluation materials of medical device in
accordance with relevant regulations. The original Paragraph 2 is revised into Paragraph 4 as “The applicant and filer for the
registration of medical device shall ensure the authenticity, integrity and traceability of the
materials submitted”. 3. For Article 10, Paragraph 1 is revised as “For filing the Class I medical device, the filler
shall submit the documents to the drug administration department under local municipal
people’s government”. Paragraph 2 is revised as “As for overseas filer that export Class I medical devices to China, they shall request their representative offices established in China or business entity in China as
their agents to submit filing materials and local market approval of such medical devices to the
drug administration department under the State Council.” 4. Article 11 is revised as “While applying for the registration of Class II and Class III
medical device, the applicant shall submit registration documents to the drugadministration
department under the State Council.”
“As for overseas registration applicant that export Class II and Class III medical devices to
China, they shall request their representative offices or business entity in China as agent to
submit registration documents and local market approval for such medical devices to the drug
supervisory management under the State Council. For the innovative medical devices not
marketed at home or abroad, the applicant may not submit the documentary evidence of
marketing approved by local countries or regions.” 5. For Article 13, one paragraph is added as Paragraph 2: “For the medical devices used to
treat rare diseases, the disease that is severely life-threatening with no effective treatment
measures, and the devices that are in urgent need of public health emergencies, the StateDrug
Administration may approve its registration application with special conditions and record
relevant matters in the medical device registration certificate.” Original Paragraph 2 is revised to Paragraph 3 as “While organizing technical evaluation
for medical devices, if the drug supervisory management under the State Council reckons it is
necessary to check the manufacturer’s quality management system, it shall conduct quality
management system inspection.” 6. One article is added as Article 14: “The owners of the marketing license for medical
devices shall perform the following obligations:
(i) Establish the quality management system suitable to the product and maintain the
operation effectively;
(ii) Formulate a post-marketing plan of continuous research and risk managementand
ensure its effective implementation;
(iii) Carry out the monitoring of adverse events and re-evaluation work according to laws;
(iv) Establish and implement product traceability and recallsystems;
(v) Other obligations prescribed by the drug administration department under theState
Council. The enterprises, institutions and individuals entrusted with the work of research and
development, clinical trials, and production and management by the owners of the marketing
license for medical devices shall bear the responsibilities as stipulated in the laws and
regulations and agreements.” 7. One paragraph is added as Article 15: “The agent of an overseas owner of the marketing
license for medical devices shall perform the following obligations:
(i) Handle medical device registration or filing services in accordance with the provisions of
this regulation;
(ii) Responsible for the contact between the drug administration department and the
overseas owners of the marketing license for medical devices, and notify overseas owners of
the marketing license for medical devices of relevant laws and regulations and technical
requirements in time;
(iii) Undertake the monitoring and reporting of adverse events of imported medical
devices for sale in China, and report adverse events of medical devices abroad to the drug
administration department in time according to relevant regulations;
(iv) Responsible for product recall after medical device marketing, and report to the drug
administration department;
(v) Assist the drug administration department in investigating and punishing illegal
activities of overseas owners of the marketing license for medical devices;
(vi) For illegal behavior of product quality and related services, joint liability shall be
undertaken with the owners of the marketing license for medical devices;
(vii) Other obligations stipulated by the drug administration department under the State
Council. “Medical device registration certificates or filing approval of overseas owners of the
marketing license for medical devices shall include the name, address and contact information
of the agent.” 8. Article 15 is revised to Article 17, of which Paragraph 1 is revised as “The expiry date of
medical device registration certificate is 5 years; For the registration approved with special
conditions, the drug administration department under the State Council shall specify the expiry
date in the registration certificate of medical devices. If the registration certificate needs to be
renewed before the expiry date, the applicant shall submit documents for renewal to the
original registration department 6 months before the expiry date.”
Item 3 of Paragraph 3 is revised as “With special conditions for registration approval, the
matters specified in the medical device registration certificate have not been completed within
the prescribed time limit.” 9. Article 17 is revised to Article 19 as “Medical device clinical evaluation refers to the
process of confirming whether the product meets the scope of clinical application and the
requirements for use by the applicant through clinical literature, clinical experience data, clinical trials and other information.”
“The filing of Class I medical device requires no clinical evaluation; There is no need for
clinical evaluation when applying for the registration of Class II medical device products in
principle; The registration application of Class III medical device shall take clinical evaluation. However, as for any of the following circumstances, clinical evaluation can be exempted:
(i) The medical device has clear working mechanism, design, and mature manufacturing
technique; The marketed predicate device has multiple years of clinical application without
serious adverse event record, and general intended use is unchanged;
(ii) Non-clinical evaluation can demonstrate the safety and effectiveness of the medical
device. For the Class II and Class III medical devices exempted from clinical evaluation, the
applicant shall prove the safety and effectiveness of the product in terms of basic principles, structural composition, performance, and scope of application. To carry out clinical evaluation of medical devices, clinical trials can be conducted at home
or abroad based on product characteristics, clinical risks and existing clinical data, or through
the analysis and evaluation of clinical literature data and clinical experience data of predicate
devices to prove the safety and effectiveness.
In principle, clinical trials are required for the Class III medical devices used to support or
maintain the life or clinical use of high risk.” 10. Article 19 is revised to Article 21, of which Paragraph 1 is revised as “As for Class III
medical device with high risk for human body, clinical trial shall get the approval of the drug
administration department under the State Council. The drug administration departmentunder
the State Council shall decide whether to agree the clinical trial within 60 working days from
the date of acceptance; If no decision is made within the time limit, the applicant for
registration can carry out the clinical trial. The clinical trial catalog of Class III medical device
with high risk for human body is formulated, adjusted and published by the drug administration
department under the State Council.” 11. One article is added as Article 22: “For medical devices in clinical trials used for the
treatment of seriously life-threatening disease with no effective therapy options, which may
obtain benefit through initial observations, satisfying ethically requirement and informed
consent, these medical devices can be used for other patients in the institutions that conduct
medical device clinical trials. The safety data can be used for medical device registration
applications.” 12. One article is added as Article 27: “The owners of the marketing license for medical
devices may produce medical devices by themselves or entrust a medical device manufacturer
that complies with the provisions of these regulations and meets the corresponding conditions
to produce medical devices.
If the owners of the marketing license for medical devices produce medical devices
themselves, they shall obtain the production license of medical device or file for the record in
accordance with the provisions of this regulation.
In the case of entrusting the production of medical devices, the owners of the marketing
license for medical devices shall be responsible for the quality of the medical devices entrusted
with the production and strengthen the management of the commissioned party’s production
to ensure their production in accordance with statutory requirements. The owners of the
marketing license for medical devices shall sign an entrustment agreement with the
commissioned party to clarify their rights, obligations and responsibilities. High-risk implantable medical devices may not be commissioned for production. Its
specific catalogue shall be formulated, adjusted and announced by the drug administration
department under the State Council.” 13. Article 24 is revised to Article 28 as “The owners of the marketing license for medical
devices shall, in accordance with the good manufacturing practice of medical device, establish a
sound quality management system that adapts to medical devices and ensure its effective
operation; It shall organize production strictly in accordance with technical requirements of
registered or filed product, so as to make sure the produced medical device complied with
mandatory standard and technical requirement of registered or filed product. The owners of the marketing license for medical devices shall carry out self-inspection
regularly about the condition of quality management system and submit self-inspection report
to the drug administration department of local government, autonomous region and
municipalities every year. Among them, the overseas owners of the marketing license for
medical devices shall submit a self-inspection report to the drug administration department
under the State Council through their agent. The overseas owners of the marketing license for medical devices shall report the relevant
agency information to the drug administration department of local government, autonomous
region and municipalities every year.” 14. Article 25 is revised to Article 29 as “If the changed production condition of medical
device no longer complies with the requirements of quality management system, the owners of
the marketing license for medical devices shall immediately take modification measures; If the
changes may influence the safety and effectiveness of medical device, the owners of the
marketing license shall immediately cease production activity, and report to the drug
administration department of local government, autonomous region and municipalities. Among
them, the overseas owners of the marketing license for medical devices shall report to the drug
administration department under the State Council through their agents.” 15. Article 26 is revised to Article 30, and one paragraph is added as Paragraph 2: “Medical
device products shall be given a unique identification. The rules for the unique identification of
medical devices shall be formulated and announced by the drug administration department
under the State Council.” 16. Article 27 is revised to Article 31, of which two items are added in Paragraph 2 to be
Item 1 and Item 2: “(i) The name, address and contact information of the owners of the
marketing license for medical devices, the name, address and contact information of the
overseas owners of the marketing license for medical devices; “(ii) Medical device registration number or file number;”
Item 3 is deleted. 17. Article 28 is deleted. 18. Article 30 is revised to Article 33, of which “Article 29” in Paragraph 1 is revised to
“Article 32”. One paragraph is added as Paragraph 2: “The Class II medical devices that can be operated
through routine management to ensure their safety and effectiveness requires no need to be
registered for operation, and its catalog shall be formulated by the drug administration
department under the State Council.” 19. Article 31 is revised to Article 24, of which “Article 29” in Paragraph 1 is revised to
“Article 32”. 20. One article is added as Article 35: “The owners of the marketing license for medical
devices may sell medical devices by themselves or entrust a medical device marketing
enterprise that meets the requirements of this regulation.
If the owners of the marketing license for medical devices sell medical devices on their
own, they requires no need to apply for medical device business licenses or record, but they
shall meet the business conditions stipulated in this regulatio
