How to file class I medical device?

Registration of class I medical device in China

Background

Do you know there is risk-based registration approach in China in term of medical device? For low risk class I medical device you have to file the product with Chinese authority with basic documents.

Recently a new order “Class I medical device filing” (no. 62 in 2022) replaces previous one (no. 26 in 2014) There are simplified documents needed for class I medical device. The filing number is provided in the form of “Notification of Filing”, and the “Filing Certificate” is no longer provided.

Prerequisite and classification

To mark the overseas class I medical device in China, the prerequisite is home country approval. One of the submission dossiers is certificate of class I medical device.

The exception is for innovative medical device without home country approval. The application procedure of innovative medical device has its own chanal which bears a Chinese patent.

It stipulate in Chinese regulation:

“Documents proving that the product is on the market in home country of legal manufacturer or production site”.

To determine the registration pathway, the first step is to classify your product matching “classification catalogue” (only for class I, no. 158 in 2021) in China. The key is that the intended use of medical device should be among the description in “classification catalogue”. Then you have only a quick filling process to mark class I medical device in China which requires relative low efforts to prepare respective documents and faster approval process. Compared to class II and III medical device, legal manufacturer of class I medical device don’t need type testing, clinical evaluation and even risk management.

Chinese agent

You need always a Chinese agent for registration of all classes of medical devices. It is quasi a representative for registration issue and plays regulatory responsibility in the whole Chinese lifecycle of medical device.

It stipulates in “State Council Ordinance 739 in 2021” about Chinese agent (same as Registrants for class II and III MD and record holders for class I MD):

“Article 20 Registrants and record holders of medical device shall perform the following duties:

(1) Establish and adapt product quality management system and applies it effectively;
(2) Development of post-marketing studies and risk management plan and to ensure the effective implementation;
(3) Carry out adverse event monitoring and re-evaluation in accordance with the law;
(4) Establish and implement product traceability and recall system;
(5) Other obligations stipulated by the drug regulatory department of the State Council. The domestic legal person designated by overseas manufacturers shall assist the registrant and filing party in fulfilling the obligations stipulated in the preceding paragraph"

Time and cost

There is no cost for registering (or filling or listing) the class I medical device in China. The review process can take some weeks. The “Notification of Filing Number” has no expiration date.

Post market activities

As for all classes medical devices, even for lowest class I medical device, legal manufacturer has to report serious adverse event or recalls to Chinese authority. All places where the class I medical device is placed in supply chain from Chinese distributor, any subcontractor for logistic, any levels of hospitals can be inspected. In theory NMPA might inspect overseas manufacturers.

Chinese PSUR is needed too, however legal manufacturer don’t need to submit it to NMPA and keep it as QM record internally.

So far the UDI is not essential to register for class I medical device.

However, annual self-inspection report of medical device quality management system (since April, 2023) is not waived for low class I medical device.

Needed document at filling process

The applied regulation of listing class I medical device in China is “Requirements and instructions for filing materials for Class I medical devices”. It is newly revised in 2022 Aug which applies class I MD and IVD.

Old in 2014

· Application form

· Documents proving that the product is on the market in home country of legal manufacturer or production site

· Info of Chinese agent

· Risk management

· Product technical requirements

· Testing report

· Clinical evaluation

· IFU and label

· Info of production (work flow, info of each production sites, info of outsourced manufacturing)

· Declaration of conformity

o Requirements and instructions for filing materials for Class I medical devices

o Classification rule of class I MD and IVD

o Chinese state – (GB) and industrial (YY) standards

o Authenticity of the filing materials submitted

New since 2022

· Proof of production

· Documents proving that the product is on the market in home country of legal manufacturer or production site

. Info of Chinese agent for foreign manufacturer (Power of Attorney, Letter of Commitment Copy of the Business License of the Agent)

· Product technical requirements

· Testing report

· IFU and label (Chinese)

· Info of production (work flow, info of each production sites, info of outsourced manufacturing)

· Declaration of conformity

o Requirements and instructions for filing materials for Class I medical devices

o Classification rule of class I MD and IVD

o Chinese state – (GB) and industrial (YY) standards

o Authenticity of the filing materials submitted

When to change filling of class I MD

There is no guidance of design change of medical device in China besides brief mention at state council order 739, 2021. From the best good practise, if product name, model and variant, the intended use or description under scope of “classification catalogue” (see below), functional requirements under PTR and new obligatory applicable Chinese standards don’t change, NO change filling is needed.

Document needed at change

The following documents are needed if any changes of products apply:

· Change table (e.g. PTR and testing report if applicable)

· Associated file

o Info of Chinese agent for foreign manufacturer (Power of Attorney, Letter of Commitment Copy of the Business License of the Agent)

· Declaration of conformity

o Requirements and instructions for filing materials for Class I medical devices

o Classification rule of class I MD and IVD

o Chinese state – (GB) and industrial (YY) standards

o Authenticity of the filing materials submitted

Good Example of class I medical device

Notification of Filing

Besides filling number, the content of filling notification is the same as Chinese certificate for class II and III medical device.

Example of filling number

国械备20160407

Product description and intended use from classification catalogue

Product code 01-08-02, Surgical auxiliary lighting

Description: usually composed of light source, lamp holder and so on. It is divided into ceiling type, wall type or mobile type. It does not have shadowless effect.

Intended use: For use in operating and treatment rooms for localized illumination of the patient's surgical or examination area. Not for use in eye exams.

Example: Mobile LED Surgical Lights, LED Surgical Lights, Surgical Lights, Surgical Reflectors, Surgical Assisted Lights, Surgical Assisted Mobile Surgical Lights, Surgical Headlights I

Global overview

Do you as manufacturer know that in global markets of medical device only a filing (similar to notification or exemption to registration) is needed. It means maketing holder (even local distributor) just needs to only list the product without registration review. In the most cases is that home evidence - and local quality management certification are waived.

global success of all kinds of medical device

eLearning of global registration