Technical Guideline For Medical Device Registration Of Human In Vitro Assisted Reproductive Technology

Technical Guideline for Medical Device Registration of
Human In Vitro Assisted Reproductive Technology
(2018 revision)
The guideline is intended to provide technical guidance to the drug regulatory
authorities on the technical review of registration application materials, and also to
provide a reference for registration applicants to apply for registration of human in vitro
assisted reproductive technology fluids.
The guideline is considered as a general requirement for human in vitro assisted
reproductive technology fluids. Registration applicants should enrich and refine the
contents of registration application materials based on the characteristics of specific
products, and determine whether the specific content is applicable based on the
characteristics of specific products.
The guideline is a technical guidance document for registration applicants and
reviewers. It does not include administrative matters involved in registration approval, nor
is it enforced as a regulation. Other scientifically reasonable alternatives can also be used
if available, but detailed research data and verification data are required to be provided.
The guideline should be used in compliance with relevant regulations and standards.
The guideline is formulated under the current system of laws and standards and the
current level of cognition. With the continuous improvement of laws and standards and
the continuous development of science and technology, the relevant content of this
guideline will also be adjusted in a timely manner.
I. Scope of application
The guideline applies to human in vitro assisted reproductive technology fluids
administered in accordance with medical devices. Human in vitro assisted reproductive
technology fluid refers to liquid medical device products that come into direct or indirect
contact with human gametes and / or embryos to prepare, cultivate, transfer or store human
gametes and / or embryos, such as oocyte retrieval, oocyte and embryo treatment fluid,
sperm washing fluid, sperm density gradient separation fluid, sperm immobilization fluid, in
vitro fertilization fluid, cleavage embryo culture fluid, blastocyst culture fluid, gamete /
embryo freezing fluid, gamete / embryo thawing fluid, culture oil and so on.
II. Division of registration units
Products with different chemical composition or ratio should be divided into different
registration units, but products used in the same operation step can be put into the same
registration unit. For example, the components or solutions with different ratios used in
order to achieve gamete / embryo vitrification in vitrified freezing solution are products
used in the same operation step, and can be put into the same registration unit.
III. Requirements for registration application materials
The registration application materials shall be provided in accordance with the
“Announcement on the Requirements for the Publication of Medical Device Registration
—— 2 —
Application Materials and the Approval Document Format” (China Food and Drug
Administration Announcement No. 43 of 2014), and shall include but not limited to
following aspects,
(I) Summary document

1. Describe the working principle, action mechanism (if applicable), and
   characteristics of the product that distinguish it from other similar products.
2. Provide the product formula (feeding ratio) and the chemical names in Chinese and
   English, the theoretical concentration of each component, and the effect of all the
   components in the final product in the form of a table.
3. Provide relevant materials of product raw materials, including the sources of each
   raw material, quality control standards and their determination basis, verification data,
   etc. The applicant should submit relevant information to explain the safety and
   effectiveness of each component, such as material safety data sheets, relevant
   toxicological data, clinical application history and other supporting information. Indicate
   whether the constituent materials contain pharmaceutical ingredients, and if so, please
   provide certification documents for the drugs contained in them that the drugs have been
   registered in China or approved for marketing by the country of origin. Regarding product
   water, please provide its quality control standards and verification reports.
4. Models and specifications: For products with multiple models and specifications,
   the differences between the models and specifications should be clarified, and the
   structural composition, functions, and performance indicators of each model and
   specification should be described, and specify whether the products of various models and
   specifications are single-dose solution.
5. Describe in detail the material and