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01 INTRODUCTION
Regulatory Body :
● Medical Devices are regulated in China by the National Medical Products
Administration (NMPA). Formerly known as the China Food and Drug
Administration (CFDA). (Est. in 1998 and renamed in 2018)
● The NMPA departments dealing with medical devices are:
○ Department Of Medical Device Registration – Responsible for Pre-
Market Approval
○ Department of Medical Device Supervision – responsible for post-
market supervision
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THE MARKET How To Enter The Chinese Market ?
IMPORT
Faster market Entry and low
8.3% captial investment
Global Share
($ 42 bn approx.) SET UP LOCAL OPERATION
More Capital and Longer time to
enter, but beneficial in the long – run
PARTNER WITH OEM
(Source : https://www.medicaldevice- A local OEM partner helps the company meet local
network.com/comment/medical-devices-industry- production mandates, thereby reducing regulatory
china/)
barriers
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Salient Features
o Separate concept of IVD does not exist
in China.
o GB (Guobiao) and YY standards similar
to CE certification in EU.
o Devices from Hong Kong , Macau and
Taiwan are considered imported.
o UDI requirements are similar to those
in the US and European Union
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Risk Based Classification
Class I Class II Class III
Low Risk Moderate Risk High Risk
Mostly implanted into
human body used for life
Safety and Effectiveness Strict control is required to
Support. Strict control and
can be ensured by routine ensure the safety
special methods required
administration and effectiveness
to ensure the safety and
effectiveness
Examples: Electrical Examples: Ventilators,
Examples: Canes,
wheelchairs, ECG machine, COVID-19 test kits
Examination gloves, goggles
Blood pressure monitors Orthopaedic implants,
Record filing with NMPA Registration (Provincial level) Registration with NMPA
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Classification Based On Body Contact
Medical Device Temporary Short Term Long Term
Use
S T C S T C S T C
Medical Dressing I II II I II II – III III
Invasive Instruments I II III II II III – – –
Reusable Surgical I I II – – – – – –
instruments
Implanted Devices – – – – – – III III III
S : Skin or Body Orifice , T: Injured Tissue, C : Central Circulatory or Nervous System
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Time, Cost and Complexity of Registration
Classification Class I Class II Class III
Time required for approval < 1 Week 12-20 months 12-22 months
Validity of registration Does not expire 5 Years 5 Years
Renewal should be started Not Applicable 18-24 months 18-24 months
this far in advance
Cost $10,000 – $15,000 > $50,000 > $50,000
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02 Approval Process :
● Approval of medical device based on – Classification and Origin.
● The Classification – Class I, Class II and Class III.
● Origin – Domestic and Imported.
● For imported medical device – Applicants needs to designate a representative
office or an agent within the territory of China to conduct the application.
● All documents must be provided in simplified Chinese.
● Before initiating the application to sell an imported device in China the device
must be approved for use by the country of the origin of the device
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Flow Chart Of The Approval Process
Medical Products If required
Clinical Trial Application
Imported
Domestic
Clinical Trial
Authorize representative
office or agent in China Filing application (self Registration Application
testing can be submitted)
Classification Correction and Correction and
requirement of requirement of
supplementary documents
supplementary documents
Class I Product technical Class II & Class III Administrative Administrative
requirement preparation evaluation on evaluation on
application materials application materials
Correction and requirement of
Provide testing sample, technical supplementary documents
and other materials for application Technical Evaluation
of registration testing
Filing approved
and fliling-
Registration approved and
Registration testing based on the certificate granted
registration–certificate
product technical requirement
granted
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Approval Process :
● STEP 1
● Determine classification of medical device in China according to China Food and
Drug Administration (CFDA).
● STEP 2
● Prepare product technical requirement document according to CFDA. The product
technical requirements contains details of testing that needs to be conducted
before registration.
● STEP 3
● Imported class II and III devices, needs to undergo type testing where the foreign
medical device must be sent to accredited testing institutes by NMPA in China. The
testing must be conducted by a qualified testing institute of medical devices,
following the product technical requirement.
● The test center must be approved by the State Food Drug Supervision
Administration and the State Quality Supervision Inspection and Quarantine
Administration.
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Approval Process :
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Approval Process :
● STEP 4
● For Classes II and III devices, clinical trials conducted in China might be required.
● According to the guidelines for clinical trials recently published by CFDA, imported
medical devices that fulfill the following requirements no longer need an extra
clinical trial in China:
1. The imported medical device is already tested in clinical trial outside the territory of
China.
2. The conducted clinical trial outside the territory of China fulfills the technical
requirements of Chinese regulations and technical guidance for registration, such as
sample size, control group selection, evaluation indexes and evaluation principles,
etc.
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Approval Process :
● STEP 5
● Submit dossier for application of filing (class I devices) or registration (class II and III
devices).
● Applicants of class I devices can submit a self-testing report.
● For imported class I devices, the results of tests conducted outside the territory of
China are usually acceptable.
● For class II and III devices, test results both in the home country and in China are
required.
● Applicants of imported devices need to submit a notarized agent authorization
letter, test reports, clinical trial data (if required), proof of home country approval,
e.g., Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG),
notarized proof of qualification of the manufacturer, e.g., CE-Certificate or
Premarket Approval (PMA) following ISO-13485 or 510(k) letter, and other
documents.
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Approval Process :
● STEP 6
● For Class I devices, an administrative review is conducted, while the submitted
application documents of class II and III devices undergo an administrative review
and a technical review.
● In some cases, QMS inspection will be organized by the regulatory authority. A
technical review with external experts or a joint review with drug review institutes
is sometimes required, which takes extra time.
● STEP 7
● Class I devices which successfully pass the review of regulatory authority receive a
Filing-Certificate, which does not expire. For Class II and III devices, the regulatory
authority issues Registration-Certificates following successful review.
● A Registration-Certificate is valid for 5 years.
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REQUIRED DOCUMENTS :
1. Application Form
2. Legal documentation
• Registration certificate, proof of qualification of the manufacturer which are issued by an
accredited authority in the original country of registration and production.
• QMS Certificate
• Authority, obligation and copies of business license or registration certificate of the
designated agencies.
3. Checklist for medical device safety and effectiveness requirements
4. Summarized documentation
• Overview
• Product description
• Model specification
• Packaging description
• Scopes and contraindications
• Overview previous generations or similar products (if exist)
• Other
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REQUIRED DOCUMENTS :
● 5. Research documentation
• Performance study
• Evaluation of biocompatibility
• Research data of biosecurity
• Validation data of sterilization and disinfection technology
• Research data of the validity and packaging
• Animal research data
• Software validation data
● 6. Production documentation
• Description of the manufacturing processes for active / passive products
• Production site
● 7. Clinical evaluation documentation
● 8. Risk analysis documentation
● 9. Product technical requirements
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REQUIRED DOCUMENTS :
● 10. Type-test report
• Review of the CFDA
• Comments on the Pre-Evaluation
● 11. Design of operation manual and label
• Operation manual
• Label for the smallest sales unit
● 12. Declaration of conformity
• Declaration of conformity with „The Regulations for the Supervision and Administration of
Medical Devices“ and other related regulations
• Declaration of the authenticity of documents submitted
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POST MARKET REGULATION
DEATH Must Be reported within 5 Days
INJURY Reported within 15 days after discovery
Annual Report Manufacturers must submit Summary of
adverse events for class II and Class III devices.
If severe injuries or a death was caused an expert
RECALL team reevaluates the device in order to decide
whether to demand a recall or revoke the registration
certificate. A failure to recall results in fines
three times the value of the device.
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03 CURRENT REGULATIONS
● China’s new Regulation on the Supervising and Administration of Medical Device
(the “New Regulation”) took effect on 1 June 2021. The New Regulations are a
third revision of the regulations which were first promulgated in April of 2000.
● The most important changes under the New Regulation focus on the reform of the
current medical device application, review and approval process, encouraging
innovation in the industry as well as formalizing the mechanism taking research
and development to commercialisation.
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CURRENT REGULATIONS
● Expansion of MAH System Nationwide
o The Revised RSAMD stipulates that a medical device MAH is ultimately responsible
for the safety, quality, and efficacy of the device throughout its whole life cycle
and sets forth a concrete, consolidated list of MAH responsibilities and obligations,
including research and development, manufacturing, distribution, and
post-marketing surveillance.
o The MAH remains ultimately responsible for the quality management of the entire
manufacturing process, and should ensure that the production is carried out in
accordance with legal and regulatory requirements of China.
o If distribute their own registered or filed devices, MAHs are exempt from
obtaining a medical device distribution license.
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CURRENT REGULATIONS
● Encouragement Of Innovation
i. Article 8 permits priority review and approval of innovative medical devices.
Article 9 calls for support for the promotion and application of new medical
devices technologies. Article 26 encourages medical institutions to undertake
clinical trials of innovative medical devices.
ii. Priority Review
iii. Conditional Approval
iv. Emergency Use
v. One-time Importation of Medical Devices for Urgent Clinical Need :- NMPA has
authorized Hainan PMPA to approve this kind of one-time importation in the
Hainan Bo’ao Medical Tourism Pilot Zone since 2018, and the Revised RSAMD
expands this authority nationwide.
vi. Laboratory Developed Tests
vii. Prohibition on the Import of Used Medical Devices
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CURRENT REGULATIONS
● Facilitating Medical Device Registration and Filing
i. Self inspection :- alleviate the problem of limited capacity amongst certified
third-party medical device inspection institutions and the rapidly growing demand
for inspection within the industry
i. The Revised RSAMD also exempts innovative medical devices that have not yet
been marketed overseas from submitting the marketing authorization in foreign
jurisdictions when applying for registration in China. This means that imported
medical devices do not have to wait for marketing authorization abroad to register
in China
❑ Clinical Evaluation Reform
i. Clinical Trial Implicit Approval ii. Clinical Evaluation Exemption
iii. Expanded Access Programs
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CURRENT REGULATIONS
● Medical Device Distribution
i. New Exemption for Medical Device Distribution Filing.
ii. Exemption for imported innovative medical devices
iii. Medical Device Online Distribution
iv. Penalty Exemption for Certain Distributors
❑ Improvement of the Medical Device Traceability System
MAHs are required to establish a product tracing system, and medical device
distributors and users, such as hospitals, are required to retain appropriate records and
implement the medical device traceability system( UDI)
❑ Enhanced Penalties
Liability for Violation of Medical Device GCPs
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04 CONCLUSION
• China has developed its own regulation independently of the GHTF.
• The definitions is almost similar excludes IVDs and classification is on risk basis
• China compulsory certifications is there for certain medical devices
• Independent laboratories for inspection :- QMS, manufacturing site.
• Review by municipal authority
• Labelling for medical device :- Chinese language
• Keep on updating and in regulatory section has various news ,notices, inspection
reports, examination results, amended regulations, specification has been given.
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REFERENCES :
DOCUMENTS
LINKS
– http://english.nmpa.gov.cn/medicaldevices.html
– China Product Registration, Renewal & Modification – China Med
Device
– https://www2.deloitte.com/cn/en/pages/life-sciences-and-
healthcare/articles/chinese-medical-device-industry-whitepaper.html
– https://www.regdesk.co/an-overview-of-medical-device-regulations-
in-china/
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