Type testing, also known as medical device registration testing, is a mandatory requirement by the National Medical Product Administration (NMPA), the equivalency of the FDA in China, for market approval of medical devices.
Type testing involves activities that determine whether a medical device complies with the requirements of specifications, technical standards, or regulations. As per NMPA requirements, the applicant needs to draft a Product Technical Requirements (PTR). The PTR serves as the protocol for the type testing, which contains the testing methods, performance indicators, and applicable technical standards for the proposed product, etc. The PTR is also part of the registration certificate and needs to be appropriately maintained by the manufacturer.
Order 739 Allows Self-Testing Report
Starting from June 2021, China enters the new era of medical device registration, with the implementation of the newly updated fundamental regulation of medical devices – Order 739 issued by the State Council — Officially named as “Regulations on the Supervision and Administration of Medical Devices.” Before Order 739, medical device manufacturers must perform type testing and obtain the testing report at NMPA certified laboratories in China. One of the significant changes of Order 739 allows manufacturers to submit a self-test report or commission a qualified medical device testing laboratory to perform the tests and issue a testing report, which is a major adjustment to medical device registration work requirements.
Release of Management Provision on the Self-Testing of Medical Device Registration
On October 22nd, 2021, based on the regulations in Order 739, the NMPA issued the Management Provision on the Self-Testing of Medical Device Registration (“The Provision”). This Provision is divided into six parts, including:
Self-testing capability requirements
Self-testing report requirements
Commissioned testing requirements
Submission dossier requirements
On-site inspection requirements
Liability requirements
Highlights of the Self-Testing Provision
1.Develop related QMS Documents
The capability of performing self-test involves the requirements of testing personnel, equipment and environment, sample control, quality control, and record control, etc. Most importantly, the self-test work should be incorporated into the medical device quality management system. Registration applicants should develop QMS documents (including quality manuals, procedures, operating instructions, etc.), risk management documents, and medical device-related regulatory documents.
2.Self-testing at the registration applicant’s laboratories
The registration applicant’s laboratories where the type testing is performed shall have specific qualifications. For example, suppose the lab is in China. In that case, it must be certified by the CNAS (China National Accreditation Service for Conformity Assessment) as per the Chinese equivalency of the Good Laboratory Practice. In the lab is outside China, it must obtain specific certification from the local regulatory body.
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3.Commission testing
As per the Self-testing Provision, if the registration applicant cannot perform specific testing items at its laboratories, they can entrust the tests to a qualified medical device testing lab. However, the qualification of the testing laboratories shall comply with Article No. 75 of Order 739, which limits the qualification to NMPA certified laboratories. In summary, if the applicant wants to commission type testing to a thirdparty lab, that lab must be an NMPA certified lab in China.
4.On-site inspection
For registration applicants who submit a self-testing report, when conducting on-site inspections of the medical device registration quality management system, the NMPA shall not only follow the requirements of the relevant medical device registration quality management system verification guidelines but also follow the “Self-inspection Capability Requirements” in the first part of this Provision.
5.Liability requirements
If the self-testing report provided by the registration applicant is false, it shall be punished per Article 83 of Order 739. If the entrusted party issues a false report, it shall be penalized per Article 96 of Order 739.
Summary
Perform the entire type testing in China at NMPAcertified labs.
Perform the entire type testing at your own lab that is certified by your home country’s regulatory body per GLP requirements.
Perform some testing items at your own lab and entrust NMPA certified lab in China to perform the tests that are out of your capabilities.
No matter where you perform the tests, the key is to develop a PTR compliant to NMPA requirements and includes all the testing items and technical standards applicable to your products.
Based on the PTR, BradyKnows (IMD) can help you develop a customized strategy to find out the best option for running type testing in an efficient and economical approach.
More and more new guidelines are published according to the Regulations on Supervision and Administration of Medical devices (Order 739), the Administrative Measures for Registration and Filing of Medical Devices (Order 47) and the Administrative Measures for Registration and Filing of IVD (Order 48). Since Jan 1, 2022, new requirements for medical device/IVD registration application dossiers will be effective.
Key notes for new requirements
For innovative medical devices, it is acceptable to have no home country approval when applying China registration.
Legal agent on the certificate for overseas manufacturers shall be the enterprise with legal person based in China.
If the product structure features, intended use, use method etc. are not consistent with the applicable scope of mandatory standards, the applicant shall submit the statement to indicate such mandatory standards are not applicable, and provide the proof after validating.
More detailed requirements for software description documents and cybersecurity documents.
More detailed requirement for clinical trial dossiers, such as raw data base for clinical trial
Adding requirement on QMS dossiers
Etc.
To understand more requirements for China medical device and IVD registration, please attend our upcoming webinar: Revisiting Order 739 – Significant Updates for Medical Device Registration in China: Dossier Prep, Self-Testing, CER, and PMS on Nov 18, 2021, 8:00-9:00 AM Pacific Time (US).
Recently, NMPA issued an announcement on the implementation of the second batch of Unique Device Identification (UDI) of medical devices (Order 114 of 2021).
From January 1, 2021, the first batch of 69 medical device varieties in 9 categories were required to have UDI. Regarding the second batch of UDI, detailed information can be found as below:
Effective Time: June 1st, 2022
Scope of Application: on the basis of the first batch, the remaining Class III medical devices (including in vitro diagnostic reagents) shall be included in the second batch of the UDI implementation.
Note: after June 1st, 2022, when applying for the initial registration, renewal or change of registration, the applicant / registrant shall submit the device identifier of its minimum sales unit in the registration management system. Device identifier will not be reviewed as part of the registration dossiers, and the change of device identifier itself is not a change of registration.
As a member of IMDRF (International Medical Device Regulators Forum), China is actively leading and participating in the formulation of relevant regulatory documents for international medical devices. Since 2019, NMPA has initiated to amend current China GCP (Good Clinical Practice), and in this May, NMPA collected public opinions on the draft of new China GCP.
Major amendments in GCP are listed as followings:
1.IVD clinical trial regulated by GCP as medical device
2.Clarify the responsibilities of each party involved in clinical trial
Sponsor is a major role in clinical trial
Risk management into clinical trial
Sponsor’s QMS shall cover the whole process of clinical trial
3.Sponsor’s QMS shall cover the whole process of clinical trial
4.Simplify and optimize some requirement
Delete the requirement of Medical device clinical trial shall be conducted in two and above clinical trial institutions, solving the issue of some medical devices difficult and not necessary to conduct clinical trial in two sites.
Delete the requirement on test report with 1-year validity (one important dossier for IRB/EC application), beneficial to clinical trial.
5.Reflect the requirement of latest international regulatory system (IMDRF MDCE WG/N57 FINAL:2019)
Introducing the concept of conducting multi-region clinical trial in different countries or regions
Beneficial to global innovative device conducting medical device clinical trial in China in parallel
Although new amendments in GCP are conductive to clinical trial in China, the requirements of clinical trial following GCP have always been enhanced. The least burdensome clinical approach is the most critical issue for China entry plan related to cost and time.
Brady knows the the least burdensome clinical approach whether you are marking clinical strategic plans, launching pre-market or post-market clinical trials, writing a CER to meet country-specific requirements, or collecting real-world data to support your submission. Reach out to BradyKnows for the least burdensome clinical approach via info@inspirativemed.com
For the gene mutation detection reagent of tumor companion diagnosis (CDx), if the gene is known to have multiple mutation sites for the same companion diagnosis purpose (such as the same companion drug), the coverage of mutation sites shall be fully considered in combination with product risk benefit analysis in subsequent product design, and the detection range of sites shall not be arbitrarily reduced for the convenience of product evaluation. For example, when KRAS gene mutation is used for tumor companion diagnosis, because it is a negative companion diagnostic gene detection and related to adverse drug reactions, insufficient coverage of mutation sites may increase the risk of patients.
Type testing, also known as medical device registration testing, is a mandatory requirement by the National Medical Product Administration (NMPA), the equivalency of the FDA in China, for market approval of medical devices.
Type testing involves activities that determine whether a medical device complies with the requirements of specifications, technical standards, or regulations. As per NMPA requirements, the applicant needs to draft a Product Technical Requirements (PTR). The PTR serves as the protocol for the type testing, which contains the testing methods, performance indicators, and applicable technical standards for the proposed product, etc. The PTR is also part of the registration certificate and needs to be appropriately maintained by the manufacturer.
Order 739 Allows Self-Testing Report
Starting from June 2021, China enters the new era of medical device registration, with the implementation of the newly updated fundamental regulation of medical devices – Order 739 issued by the State Council — Officially named as “Regulations on the Supervision and Administration of Medical Devices.” Before Order 739, medical device manufacturers must perform type testing and obtain the testing report at NMPA certified laboratories in China. One of the significant changes of Order 739 allows manufacturers to submit a self-test report or commission a qualified medical device testing laboratory to perform the tests and issue a testing report, which is a major adjustment to medical device registration work requirements.
Release of Management Provision on the Self-Testing of Medical Device Registration
On October 22nd, 2021, based on the regulations in Order 739, the NMPA issued the Management Provision on the Self-Testing of Medical Device Registration (“The Provision”). This Provision is divided into six parts, including:
Self-testing capability requirements
Self-testing report requirements
Commissioned testing requirements
Submission dossier requirements
On-site inspection requirements
Liability requirements
Highlights of the Self-Testing Provision
Develop related QMS Documents
The capability of performing self-test involves the requirements of testing personnel, equipment and environment, sample control, quality control, and record control, etc. Most importantly, the self-test work should be incorporated into the medical device quality management system. Registration applicants should develop QMS documents (including quality manuals, procedures, operating instructions, etc.), risk management documents, and medical device-related regulatory documents.
Self-testing at the registration applicant’s laboratories
The registration applicant’s laboratories where the type testing is performed shall have specific qualifications. For example, suppose the lab is in China. In that case, it must be certified by the CNAS (China National Accreditation Service for Conformity Assessment) as per the Chinese equivalency of the Good Laboratory Practice. In the lab is outside China, it must obtain specific certification from the local regulatory body.
Commission testing
As per the Self-testing Provision, if the registration applicant cannot perform specific testing items at its laboratories, they can entrust the tests to a qualified medical device testing lab. However, the qualification of the testing laboratories shall comply with Article No. 75 of Order 739, which limits the qualification to NMPA certified laboratories. In summary, if the applicant wants to commission type testing to a thirdparty lab, that lab must be an NMPA certified lab in China.
On-site inspection
For registration applicants who submit a self-testing report, when conducting on-site inspections of the medical device registration quality management system, the NMPA shall not only follow the requirements of the relevant medical device registration quality management system verification guidelines but also follow the “Self-inspection Capability Requirements” in the first part of this Provision.
Liability requirements
If the self-testing report provided by the registration applicant is false, it shall be punished per Article 83 of Order 739. If the entrusted party issues a false report, it shall be penalized per Article 96 of Order 739.
Summary
Perform the entire type testing in China at NMPAcertified labs.
Perform the entire type testing at your own lab that is certified by your home country’s regulatory body per GLP requirements.
Perform some testing items at your own lab and entrust NMPA certified lab in China to perform the tests that are out of your capabilities.
No matter where you perform the tests, the key is to develop a PTR compliant to NMPA requirements and includes all the testing items and technical standards applicable to your products.
Based on the PTR, BradyKnows (IMD) can help you develop a customized strategy to find out the best option for running type testing in an efficient and economical approach.
More and more new guidelines are published according to the Regulations on Supervision and Administration of Medical devices (Order 739), the Administrative Measures for Registration and Filing of Medical Devices (Order 47) and the Administrative Measures for Registration and Filing of IVD (Order 48). Since Jan 1, 2022, new requirements for medical device/IVD registration application dossiers will be effective.
Key notes for new requirements
For innovative medical devices, it is acceptable to have no home country approval when applying China registration.
Legal agent on the certificate for overseas manufacturers shall be the enterprise with legal person based in China.
If the product structure features, intended use, use method etc. are not consistent with the applicable scope of mandatory standards, the applicant shall submit the statement to indicate such mandatory standards are not applicable, and provide the proof after validating.
More detailed requirements for software description documents and cybersecurity documents.
More detailed requirement for clinical trial dossiers, such as raw data base for clinical trial
Adding requirement on QMS dossiers
Etc.
To understand more requirements for China medical device and IVD registration, please attend our upcoming webinar: Revisiting Order 739 – Significant Updates for Medical Device Registration in China: Dossier Prep, Self-Testing, CER, and PMS on Nov 18, 2021, 8:00-9:00 AM Pacific Time (US).
Recently, NMPA issued an announcement on the implementation of the second batch of Unique Device Identification (UDI) of medical devices (Order 114 of 2021).
From January 1, 2021, the first batch of 69 medical device varieties in 9 categories were required to have UDI. Regarding the second batch of UDI, detailed information can be found as below:
Effective Time: June 1st, 2022
Scope of Application: on the basis of the first batch, the remaining Class III medical devices (including in vitro diagnostic reagents) shall be included in the second batch of the UDI implementation.
Note: after June 1st, 2022, when applying for the initial registration, renewal or change of registration, the applicant / registrant shall submit the device identifier of its minimum sales unit in the registration management system. Device identifier will not be reviewed as part of the registration dossiers, and the change of device identifier itself is not a change of registration.
As a member of IMDRF (International Medical Device Regulators Forum), China is actively leading and participating in the formulation of relevant regulatory documents for international medical devices. Since 2019, NMPA has initiated to amend current China GCP (Good Clinical Practice), and in this May, NMPA collected public opinions on the draft of new China GCP.
Major amendments in GCP are listed as followings:
IVD clinical trial regulated by GCP as medical device
Clarify the responsibilities of each party involved in clinical trial
Sponsor is a major role in clinical trial
Risk management into clinical trial
Sponsor’s QMS shall cover the whole process of clinical trial
Sponsor’s QMS shall cover the whole process of clinical trial
Simplify and optimize some requirement
Delete the requirement of Medical device clinical trial shall be conducted in two and above clinical trial institutions, solving the issue of some medical devices difficult and not necessary to conduct clinical trial in two sites.
Delete the requirement on test report with 1-year validity (one important dossier for IRB/EC application), beneficial to clinical trial.
Reflect the requirement of latest international regulatory system (IMDRF MDCE WG/N57 FINAL:2019)
Introducing the concept of conducting multi-region clinical trial in different countries or regions
Beneficial to global innovative device conducting medical device clinical trial in China in parallel
Although new amendments in GCP are conductive to clinical trial in China, the requirements of clinical trial following GCP have always been enhanced. The least burdensome clinical approach is the most critical issue for China entry plan related to cost and time.
Brady knows the the least burdensome clinical approach whether you are marking clinical strategic plans, launching pre-market or post-market clinical trials, writing a CER to meet country-specific requirements, or collecting real-world data to support your submission. Reach out to BradyKnows for the least burdensome clinical approach via info@inspirativemed.com
For the gene mutation detection reagent of tumor companion diagnosis (CDx), if the gene is known to have multiple mutation sites for the same companion diagnosis purpose (such as the same companion drug), the coverage of mutation sites shall be fully considered in combination with product risk benefit analysis in subsequent product design, and the detection range of sites shall not be arbitrarily reduced for the convenience of product evaluation. For example, when KRAS gene mutation is used for tumor companion diagnosis, because it is a negative companion diagnostic gene detection and related to adverse drug reactions, insufficient coverage of mutation sites may increase the risk of patients.
Founded in 2007, BradyKnows is a China Market Entry Consulting Firm for both medical device and In Vitro Diagnostic (IVD) companies. In 2021, we established Inspirative Medical in the United States to better multi-culturally communicate with global clients and overcome gaps in R&D/standards/regulations/QMS/PMS between China and other countries.
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BradyKnows offers market entry strategy, regulatory and quality consulting, clinical strategy/CER/trials, local testing, legal representation, and commercialization.
We build elite teams for our clients with the full participation of project managers, regulatory/clinical/quality consultants, and technical engineers. The elite team will accompany our clients in the entire product life-cycle and help them overcome challenges and achieve every milestone in China.
