The NMPA issued the second draft “Regulations on Self-test of Medical Device Registration (Draft)” on July 23, 2021, proposing further guidance to manufacturers on how to self-test and to submit the testing report.
Decree 739 Regulation on Supervision and Management of Medical Devices, announced on March 18, 2021, allows self-test report to replace the report submitted by authorized testing centers. It says that “testing report can be the self-test report of the medical device registration applicant or filing person, or the test report issued by a qualified medical device test agency”. In the Decree 680 issued in 2017, only Class I device can utilize self-test report.
Renewed Guidance for Self-Test Medical Devices
NMPA released the first draft on June 2, 2021. Compared to the first one, the following aspects have been added to the newly-published document:
1. Clarified self-test standards from perspectives of equipment, quality control and record control
- The applicant should have adequate equipment and environmental facilities that meet the requirements of the inspection method. Establish and save the equipment and environmental facilities’ files, operating procedures, measurement/calibration certificates, use and maintenance records, and trace the value according to relevant regulations.
- For laboratories that carry out special inspections, such as biological evaluation, electromagnetic compatibility, biological safety laboratories, etc., their environmental facilities should meet the specific requirements.
- Check quality control requirements. The registration applicant should be able to use appropriate methods and procedures to carry out all inspection activities. When appropriate, it shall include the evaluation of measurement uncertainty and the use of statistical techniques for data analysis.
- Encourage applicants to participate in related testing/interlaboratory comparison organized by testing institutes to improve testing capabilities.
2. Clarified certification of commissioned test institutes
- Testing shall be conducted at institute that has a laboratory accredited by the China National Accreditation Service for Conformity Assessment (CNAS), or the overseas institute has a laboratory accredited by a foreign government or government certified accreditation agency accredited by the government.
3. Clarified requirements of commissioning process
- The applicant for registration shall evaluate the qualifications and conformity of inspection capabilities of the testing institutes in the medical device production quality management system documents. Establish a directory of qualified entrusted parties and keep the evaluation records and evaluation reports.
- The applicant shall ensure that the self-inspected samples are consistent with the entrusted samples. Should communicate with the relevant entrusted party in a timely manner, report the problem, and assist in the relevant inspection work.
- The applicant shall summarize the reports issued by the entrusted party and form a complete self-inspection report. For items involving commissioned inspection, the content can be filled in as shown in the corresponding commissioned inspection report, and the original commissioned inspection report shall be provided.
For Annexes of Medical Device Self-Testing Report Template, and Table of Equipment for Self-inspection (including standard/reference products), please email info@ChinaMedDevice.com.
How to Test & Submit
The document specifies the following five sections:
1. Basic principles
2. Requirements for self-test report
3. Outsourcing requirements
4. Application materials requirements
5. On-site test requirements
Materials requirements include:
• Self-test report
• Statement of Self-test Capability
• QMS related materials
• Statement of Authenticity of the Report
On-site test requirements include:
• Test record
• Quality control ability
• Inspector operation skills
• Qualification requirements for inspectors
• Facilities and environment
• Testing equipment
For an English copy of the document, please email info@ChinaMedDevice.com. We have testing engineers to help you with gap analysis and expedite your type testing needs and shorten your renewal or new approval time.