1.0 Road map of registration of medical device in China

1.0 Road map of Chinese registration

1. Learning objective

In this session you should know the simplified work flow to register medical device or IVD in China as an overview.

2. Video

3. Road map of Chinese registration

a. Regulatory framework (Chinese authority)

In 2018 National Medical Products Administration (NMPA, Chinese: 国家药品监督管理局) replaced former China food and drug administration (CFDA). As one part of State Administration for Market Regulation (SAMR) NMPA is in charge of supervision of drug, medical device and cosmetics in China. The core task of NMPA is to draft legislative of drug, medical device and cosmetics and to supervise the implementation of the regulations. Besides it, NMPA is also responsible of standards, quality management, registration and post market activities including inspection of abovementioned products.

*In-vitro Diagnostics Regulation belongs also to regim of NMPA

Responsibility of NMPA:

(1) To supervise the safety of drugs (including traditional Chinese medicines (TCMs) and ethno-medicines, the same below), medical devices and cosmetics; to draw up regulatory policy plans, organize the drafting of laws and regulations, formulate normative documents, and supervise the implementation thereof; to research and formulate regulatory and supportive policies that encourage new technologies and new products for drugs, medical devices and cosmetics.

(2) To undertake standards management for drugs, medical devices and cosmetics; to organize the formulation and publication of the Chinese Pharmacopoeia and other drug and medical device standards, organize the drafting of cosmetic standards, organize the formulation of the classification management system, and supervise the implementation thereof; to participate in formulating the National Essential Medicine List, and assist in the implementation of the national essential medicine system.

(3) To regulate the registration of drugs, medical devices and cosmetics; to develop the registration system, conduct strict review and approval for marketing, improve measures to facilitate the review and approval process, and organize the implementation thereof.

(4) To undertake quality management for drugs, medical devices and cosmetics; to develop Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), and supervise the implementation thereof; to develop Good Manufacturing Practices (GMP) and supervise the implementation thereof in line with NMPA's responsibilities; to develop good practices on the distribution and use of medical products and guide the implementation thereof.

(5) To undertake post-market risk management for drugs, medical devices and cosmetics; to organize the monitoring, evaluation, and handling of adverse drug reactions, medical device adverse events, and cosmetic adverse reactions; to undertake emergency response management for drugs, medical devices and cosmetics in accordance with law.

(6) To undertake management of qualifications for licensed pharmacists; to formulate regulations of qualifications for licensed pharmacists, and guide and supervise the registration of licensed pharmacists.

(7) To organize and guide the supervision and inspection of drugs, medical devices and cosmetics; to develop the inspection system, investigate and punish illegal activities during the registration process for drugs, medical devices and cosmetics in accordance with law, and organize and guide the investigation and punishment of illegal activities during the manufacturing process in line with NMPA's responsibilities.

(8) To engage in international exchange and cooperation in the regulation of drugs, medical devices and cosmetics, and participate in developing relevant international regulatory rules and standards.

(9) To guide the work of drug regulatory departments of all provinces, autonomous regions, and municipalities directly under the Central Government.

(10) To complete other tasks assigned by the CPC Central Committee and the State Council.

Among the centers of NMPA, Chinese medical device evaluation (CMDE) performs technical evaluation of medical device. Its role is quite similar to Center for Devices and Radiological Health (CDRH) at FDA in USA.

Responsibility of CMDE

(1) Be responsible for the acceptance and technical review of registration application of domestic Class III medical device products and imported medical device products; be responsible for the filing of imported Class I medical device products.

(2) Participate in the drafting of relevant laws, regulations and normative documents related to the registration administration of medical devices. Organize the formulation and implementation of relevant technical reviews norms and technical guidelines for medical devices.

(3) Undertake the technical review of medical devices involved in emerging medical products such as regenerative medicine and tissue engineering.

(4) Coordinate the inspection work related to the evaluation of medical devices review.

(5) Carry out researches on the theories, technologies, development trends and legal issues related to medical device review.

(6) Be responsible for providing guidance and technical support for local departments in the technical review of medical devices.

(7) Organize relevant consulting services and academic exchange, and carry out international (regional) exchange and cooperation related to medical device review.

(8) Undertake other tasks assigned by NMPA.

b. Pre-market analysis

One of the most important prerequisites to register medical device in China is country of origin approval: e.g. Declaration of Conformity (EU)/ Certificate to Foreign Government (US). The exception of this prerequisite is for innovative products.

Then you have to find a Chinese agent for foreign manufacturers who submits product dossier to NMPA and acts as a liaison between authority and legal manufacturer.

The manufacturer has to define whether the subject product is medical device in China:

Medical device is an instrument, equipment, appliance, in vitro diagnostic reagent and its calibrator, material, and other similar or relevant articles including necessary computer software, directly or indirectly contacting human body; the effectiveness are obtained mainly through physical means other than pharmacological, immunological or metabolic ways, or such ways are involved in but only play auxiliary roles; which is used to achieve the following intended outcomes:

· Diagnosis, prevention, monitoring, treatment or alleviation of diseases

· Diagnosis, monitoring, treatment, alleviation or functional compensation for an injury

· Examination, substitution, regulation or support of physiological structure or physiological process

· Life support or life sustaining

· Contraception Control

· Examination of the sample from human body to provide information for medical or diagnostic purpose

Then the classification of subject product should be determined which decides the extent of technical documentation. It is wise to have a gap analysis of existing technical documentation in home country with Chinese requirement.

c. Start of registration

After pre-market strategy, the preparation of complex Chinese technical documentation is starting. Be aware to fix most difficult tasks first. While the local testing takes long, manufacturer should organize the sampling in time and send it to test in a certified Chinese lab. Depending on product code of medical device, Chinese clinical evaluation or clinical study could be very challenging.

The output of preparation is to submit electronic dossier to Chinese authority. Then the clock is ticking on the side of review of CMDE.

d. Product approval and post market

The Chinese registration could take 2 years for class II and III medical device. The success approval is rewarded as a Chinese certificate. Don’t forget that there are also many post market activities after the product is approved in China

4. Test (contact us for a free test)

1. The Chinese authority is responsible for

☐Drug

☐Medical device

☐Cosmetic

☐IVD

2. Which pre-market analysis and preparation is recommended?

☐Ask Chinese agent important regulation translated in EN to study

☐Let Chinese distributor make all dossier by providing the whole original technical documentation

☐Not consider whether ISO 13485 is still valid till submission date

☐Accept quote of consulting without gap analysis of existing documents

3. Which actions below are wrong during the preparation of dossier in China?

☐Translate 1 to 1 technical documentation to Chinese dossier without analysis and CN-requirement

☐Start dossier in paper and leave type testing later on to start

☐Make extra sterilization test in China

☐Transfer European CER to Chinese dossier without change

4. Which type of registration is the longest in term of time from the preparation to final approval?

☐Class I

☐Class II initial

☐Class III initial

☐Class III change

5. ONLY FOR PROFESSIONAL MODULE

Provide correct order of following actions (can be happening parallel). If you have already experience of Chinese registration, leave estimated time and assigned each action for respective department and try to illustrate which actions are related.

*the homework can be sent in any form, preferred e.g. in editable as Word (no more than 2 pages)

a. Finalisation of instruction for use in Chinese

b. Edit product technical requirement

c. Start local testing

d. Make a gap analysis of project

e. By uncertainness plan a pre-sub with authority

f. Project plan with time, budget and resource

g. Catch up one physical verification test

h. Production of medical device

i. Approval of subject product

j. Edit clinical evaluation

k. Send sample for test to China