(July 30, 2014, Order of the State Food and Drug Administration No. 7, announced on November 7, 2017.

Chapter 1 General Principles

Article 1 In order to strengthen the supervision and management of medical device production，Standardize the production behavior of medical equipment，Guarantee medical equipment safety、Effective，According to the "Regulations on the Supervision and Administration of Medical Device"，Formation of these measures。

III Entering Medical Device Production Campaign and Supervision and Management in the People's Republic of China，It should abide by these Measures。

Article 3 The State Administration of Food and Drug Administration is responsible for national medical device production supervision and management。Food and drug supervision and management department at or above the county level is responsible for the production supervision and management of medical device production in the administrative area。
The superior food and drug supervision and management department is responsible for guiding and supervising lower -level food and drug supervision and management departments to carry out medical device production supervision and management。

4 The State Administration of Food and Drug Administration formulates the quality management specifications of medical device production and supervision and implementation。

Fifth Food and Drug Supervision and Administration Department promptly publish information about the production license and filing of medical device in accordance with the law。Applicants can inquire about the approval progress and approval results; the public can consult the results of the approval。

Article 6 Medical device manufacturers shall be responsible for the quality of medical equipment produced。Entrusted production，The commissioner is responsible for the quality of the medical device that is commissioned by the commissioned production。

Chapter II production license and filing management

7 Entering the production of medical equipment，The following conditions shall be available:
(1) Production venue that is adapted to the production of medical equipment、​​Environment conditions、Production equipment and professional and technical personnel;
(2) Institutions or full -time inspectors and inspection equipment for medical devices produced in production;
(3) The management system for ensuring the quality of medical equipment;
(4) After -sales service capabilities that are suitable for medical devices produced by production;
(5) Compliance with product development、Requirements stipulated in the production process document。

No. 8 to open the second category、The third type of medical device manufacturer，It should be provided in the local area、Autonomous Region、Food and Drug Supervision and Management Department of the Municipality directly under the Central Government apply for production permit，and submit the following information:
(1) A copy of the business license;
(2) Copy of registration certificates and product technical requirements for medical devices held by the enterprise;
(3) Legal representative、A copy of the person in charge of the enterprise;
(4) Production、The identity of the person in charge of quality and technical、Education、Copy of Title Certificate;
(5) Production management、Quality inspection post Practitioner academic degree、List of title;
(6) Proof files of the production site，If there are special production environment requirements, the facilities shall be submitted、Copy documents of the environment of the environment;
(7) The main production equipment and inspection equipment directory;
(8) Quality manual and program files;
(9) Process flowchart;
(10) The authorized certificate of the schedule;
(11) Other proof information.

Article 9 province、Autonomous Region、The food and drug supervision and management department of the municipality directly under the Central Government receives the application，It should be processed according to the following situations:
(1) The application is its scope of power，Application information is complete、Following the legal form，The application should be accepted;
(2) Application materials are incomplete or not in line with legal forms，Should be informed of all the contents that the applicant needs correction within 5 working days，If you do not inform overdue，It will be accepted since the date of receiving the application information;
(3) Application materials exist that the wrong error can be correct on the spot，The applicant should be allowed to correct on the spot;
(4) The application matters do not belong to the scope of the head of the headquarters，It should make decisions that are not accepted immediately，and inform the applicant to apply to the relevant administrative department。
Provincial、Autonomous Region、The food and drug supervision and management department of the municipality directly under the Central Government accepts or does not accept the application for medical device production permit，Notice of acceptance or not accepted。

Article 10 province、Autonomous Region、The food and drug supervision and management department of the municipality directly under the Central Government shall review the application information within 30 working days from the date of acceptance，and conduct on -site inspections in accordance with the requirements of the quality management specifications of medical device production。On -site inspection should be based on the situation，Avoid repeated verification。It needs rectification，The rectification time is not included in the review time limit。
with prescribed conditions，Make a written decision in writing in accordance with the law，and issued the "Medical Device Production License" within 10 working days; if it does not meet the prescribed conditions，Make a written decision without license，Explain the reason。

Article 11 The first type of medical device manufacturer is opened for，The first type of medical device production filing should be handled in the municipal food and drug supervision and management department of the local area，Shopping documents of the filing vouchers produced by the filing enterprise and the information stipulated in Article 8 of these Measures (except the second item)。
The food and drug supervision and management department shall check the integrity of the information submitted by the enterprise on the spot，File with the prescribed conditions，Send to the first category of medical device production filing vouchers。

Article 12 Application for the production permit for medical device production directly involves the major interest relationship between the applicant and others，Food and Drug Supervision and Management Department shall inform the applicant、Persons with interest relationships in accordance with the law、Regulations and the relevant provisions of the State Food and Drug Administration enjoy the right to apply for hearing;，Food and Drug Supervision and Administration Department believes that major permits involving public interests，It should be announced to the society，Hold a hearing。

Article 13 The "Medical Device Production License" is valid for 5 years，Delivery license number、Corporate name、Legal representative、Corporate person in charge、Residence、Production address、Production stake sports betting appscope、issuance department、Date of issuance and validity period。
"Medical Device Production License" attached to the register of medical device production products，Delieving the product name、Registration number and other information。

Article 14 to increase production products，Medical device manufacturers shall submit the relevant information involving the content involved in the provisions of Article 8 of these Measures。
Application products that are applied for increasing production are not belonging to the original production range，The original issuance department shall review and conduct on -site inspections in accordance with the provisions of Article 10 of these Measures，with prescribed conditions，Change the production range stated by the "Medical Device Production License"，and publish product information in the registered form of medical device production products。
Application of products to increase production belongs to the scope of production，and the requirements of the production process and production conditions of the original licensed production products，The original certificate department shall review the application information，with prescribed conditions，Label product information in the registered form of medical device production products; it is different from the production process and production conditions of the original licensed production product，It shall review and conduct on -site inspections in accordance with the provisions of Article 10 of these Measures，with prescribed conditions，Label product information in the registered form of medical device production products。

Article 15 of the production address of non -written change，Should apply to the original certificate department for medical device production license change，and submit the relevant information involving the content involved in the provisions of Article 8 of these Measures。The original issuance department shall review and conduct on -site inspections in accordance with the provisions of Article 10 of these Measures，Make a decision to change or not change within 30 working days。Medical Device Manufacturing Enterprise Cross -provincial、Autonomous Region、Establishing production venues in municipality，Should apply for medical device production licenses alone。

Article 16 Enterprise Name、Legal representative、Corporate person in charge、Change of the residence or the change of the text of the site，Medical device manufacturers should be within 30 working days after the change，Applying the "Medical Device Production License" to the original certificate department for registration，and submit certification information from relevant departments。The original issuance department shall apply for change in time。The incomplete information of the changes or the requirements of the formal review，Should be notified all the content that needs to be corrected。

Article 17 "Medical Devices Production License" is valid for the expiration period.，Medical device manufacturers shall expire for its own period of 6 months，Posted the "Medical Device Production License" to the original certificate department for continuation application。
The original issuance department shall review the application for continuing application in accordance with the provisions of Article 10 of these Measures，On -site verification when necessary，Decisions for whether to continuing for continuation before the expiration of the "Medical Device Production License"。with prescribed conditions，Quasi -gen continuation。If it does not meet the prescribed conditions，Order to be rectified within a time limit; if the rectification still does not meet the prescribed conditions，No continuation，Together in writing。If the decision is not made after the deadline，deemed to be allowed to continue。

Article 18 due to separation、Medical device manufacturers with merging and existence，It shall apply for a change permit in accordance with the provisions of these Measures; due to the separation of the enterprise、Medical device production enterprise merged and dissolved，Should apply for cancellation of the "Medical Device Production License"; due to the separation of enterprises、A newly established medical device manufacturer should apply for the "Medical Device Production License"。

Article 19 The Loss of the Production of Medical Devices，Medical device manufacturers shall immediately publish lost statements on the media designated by the original certificate department。One month after the loss of the lost statement from boarding，Apply to the original certificate department for reissue。The original certificate department has timely replenished the "Medical Device Production License"。

Change of Article 20、The number and validity period of the "Medical Device Production License" replenished "Medical Device Production License"。Continuous "Medical Device Production License" number is the same。

Article 21: The content of the first type of medical device production filing voucher changes，Should change the filing。
The loss of the filing voucher，Medical device manufacturers shall promptly go through the procedures for the original filing department。

Twenty -two medical device manufacturers for investigation by the food and drug supervision and management department for investigation due to illegal production，or I received an administrative penalty decision but not yet fulfilled，Food and Drug Supervision and Management Department should suspend the license，until the case is processed。

Article 23 Medical Device Manufacturing Enterprise has laws、Regulations stipulates the situation that should be canceled，or the validity period is not full, but the company actively proposes to cancel，Provincial、Autonomous Region、The food and drug supervision and management department of municipality directly under the Central Government shall cancel its "Medical Device Production License"，and announced it on the website。

Article 24 province、Autonomous Region、The food and drug supervision and management department of municipality directly under the Central Government shall establish a "Medical Device Production License" issuance、Continuous、Change、Replenishment、Cryptive files such as revocation and cancellation。
Municipal food and drug supervision and management departments of the district shall establish the first type of medical device production filing information file。

Article 25 Any unit or individual shall not forge、STC、Sale、rental、Dedicated "Medical Devices Production License" and medical device production filing vouchers。

Chapter III Entrusted Production Management

Article 26 The commissioner entrusted by the medical device should be a domestic registor or a recorder who entrusts the production of medical devices。Where，Entrusted production does not belong to domestic medical devices that are not based on the approval of special approval procedures in accordance with innovative medical devices，The commissioner shall obtain the production license to commission the production medical device or apply for the first type of medical device production.。
The trustees entrusted to produce in medical device should obtain domestic production enterprises with the production license of the corresponding production of medical device or apply for the first type of medical device production filing。Trust party's corresponding responsibility for the quality of supporting the production of medical equipment。

Article 27 The entrusting party shall provide the trustee with the quality management system document of the commissioned medical device and the registered or filed product technical requirements，For the production conditions of the trustee、Technical level and quality management capabilities for evaluation，Confirm that the trustees have the conditions and capabilities of the trustee production，and guide and supervise the production process and quality control。

Article 28 The trustees shall be in accordance with the quality management specifications of medical equipment production、Mandatory Standards、Product technical requirements and commission production contract organization production，and save all trustee production documents and records。

Article 29 The commissioner and the trustee shall sign the commissioned production contract，Clarify the rights of both parties、Obligations and responsibilities。

Article 30 Entrust the production of the second category、The third category of medical equipment，The client should be provinced to the location、Autonomous Region、The food and drug supervision and management department of the municipality directly under the Central Government shall handle stake online sports bettingthe commission production filing; entrust the production of the first type of medical equipment，The commissioner shall apply to the municipal food and drug supervision and management department in the place where the local area is located.。with prescribed conditions，The food and drug supervision and management department shall send it to the medical device entrustment of production filing vouchers。
The following information shall be submitted when filing:
(1) Copy the registration certificate or filing voucher entrusted to the production of medical devices;
(2) A copy of the business license of the commissioner and the trustee enterprise;
(3) The "Medical Device Production License" of the trustee or a copy of the first type of medical device production filing certificate;
(4) Copy for production contracts entrustment;
(5) The authorized certificate of the organizer.
Entrusted production does not belong to the domestic medical device for approval of special approval procedures in accordance with innovative medical devices，It should also be submitted to the "Medical Device Production License" of the commissioner or a copy of the first type of medical device production filing voucher; it belongs to the domestic medical device for approval of special approval procedures for innovative medical equipment，The certificate of special approval of innovative medical equipment shall be submitted。

Article 31 Trusted Production II、The third category of medical equipment，The trustee shall go through the relevant procedures in accordance with Article 14 of these Measures，Label in the register of the medical device production product registration form。
Trusted to produce the first category of medical equipment，The trustees shall be in accordance with the provisions of Article 21 of these Measures，Handling the first type of medical device production filing to the original filing department。

Article 32: When the trustees handle the increasing trusted production product information or the production filing of the first type of medical device，Except for the information that meets the requirements of these Measures，The following information should also be submitted:
(1) A copy of the business license of the commissioner and the trustee;
(2) The "Medical Devices Production License" or the first type of medical device production filing certificate;
(3) The commissioned party medical device commission the copy of the production filing voucher;
(4) Copy for production contracts entrustment;
(5) The instructions and label samples to be adopted to commission the production of medical equipment;
(6) The client's recognition statement on the quality management system of the trustee;
(7) The commissioner's commissioner's quality of the production of medical equipment、Self -guarantee declaration of sales and after -sales service liability。
Trimming production does not belong to domestic medical devices that are approved by special approval procedures in accordance with innovative medical devices，It should also be submitted to the "Medical Device Production License" of the commissioner or a copy of the first type of medical device production filing voucher; it belongs to the domestic medical device for approval of special approval procedures for innovative medical equipment，The certificate of special approval of innovative medical equipment shall be submitted。

Article 33 The trustees' registration form of the "Medical Devices Production License" and the trustee production products in the first type of medical device production certificate shall indicate the word "trustee" and the trustee production period。

Article 34 The instruction manual entrusted to the production of medical equipment、Tags should be except for relevant regulations，It should also indicate the name of the company's corporate name、Residence、Production address、Production license number or production filing voucher number。

Article 35 When commissioning production is terminated，Article 35 When commissioning production is terminated、Autonomous Region、Municipal food and drug supervision and management departments directly under the Central Government or district report timely report。

Article 36 The commissioner can only entrust a medical device manufacturer (except the absolute controlling enterprise) for the same period of the same period of the medical device product。

Article 37: Intriguing medical devices with high risk shall not be commissioned to produce，The specific directory is formulated by the State Food and Drug Administration、Adjustment and announced。

Chapter 4 Production Quality Management

Article 38 of the medical device production enterprise shall be in accordance with the requirements of the quality management specifications of medical equipment，Establish a quality management system and maintain effective operation。

Article 39 of the medical device manufacturing enterprise shall carry out medical device laws、Regulations、Regulations、Standard and other knowledge training，Create a training file。
The operator of the production position should have the corresponding theoretical knowledge and actual operating skills。

Article 40 Medical device manufacturers shall organize production in accordance with registered or filed product technical requirements，Make sure that the medical device that is leaving the factory meets the compulsory standards and the technical requirements of the registered or filed product。The medical device from the factory shall be passed through the inspection and attached a qualified certification document。

Article 41 of the medical device production enterprise shall regularly conduct a comprehensive self -examination of the operation of the quality management system in accordance with the requirements of the quality management of medical device production，And the province where the location is located by the end of each year、Autonomous Region、Municipal food and drug supervision and management departments in municipalities or districts submit an annual self -examination report。

Article 42 The production conditions of medical device manufacturers change，No longer meets the requirements of the quality management system of the medical equipment，Medical device manufacturers should take rectification measures immediately; it may affect medical equipment safety、Effective，Should stop production activities immediately，Report to the county -level food and drug supervision and management department of the local area。

Article 43 of the medical device products have been discontinued for more than one year and have no similar products to produce，Re -production，Medical device manufacturers shall report a written report in advance、Autonomous Region、Municipal -level food and drug supervision and management departments in municipalities or districts，After the verification meets the requirements, it can be restored to production。

Article 44 of the medical device manufacturer does not have the original production license conditions or does not meet the filing information，Unable to get in touch，After the primary certificate or the filing department is announced，Log canceling the "Medical Device Production License" in accordance with the law or marked in the first type of medical device production filing information，Announcement to the society。

Article 45 of the medical device manufacturer shall be produced at the production site permitted or filled in a production site，For production equipment、Maintenance of facilities and equipment such as process equipment and inspection instruments，Make sure its normal operation。

Article 46 of the medical device manufacturer shall strengthen procurement management，Establish a supplier review system，Evaluation of suppliers，Ensure that purchasing products meet statutory requirements。

Article 47 of the medical device manufacturer shall purchase raw materials、Production、Inspection and other processes to record。Records should be true、Accurate、Full，and meet the requirements of traceable。

Article 48 The state encourages medical device manufacturers to adopt advanced technical means，Establish an information management system。

Article 49 The medical device produced by medical device manufacturers occurs major quality accidents，It should be reported to the location of the location in 24 hours、Autonomous Region、Food and Drug Supervision and Management Department of Municipality，Provincial、Autonomous Region、The food and drug supervision and management department of municipality directly under the Central Government shall immediately report to the State Food and Drug Administration。

Chapter 5 Supervision and Management

Article 50 of the Food and Drug Supervision and Administration Department in accordance with the principle of risk management，Classification and grading management of medical device production。

Article 51 province、Autonomous Region、The food and drug supervision and management department of municipality directly under the Central Government shall prepare the supervision and inspection plan of medical device manufacturers in the administrative stake betting apparea，Determine the focus of medical device supervision、Check frequency and coverage，and supervise the implementation。

Article 52 The supervision and inspection of medical device production shall be inspected to check the implementation of laws in medical device manufacturers、Regulations、Regulations、Specification、Standards and other requirements，Focus on the matters stipulated in Article 53 of the Regulations on the Supervision and Administration of Medical Devices。

Article 53 The food and drug supervision and management department organizes supervision and inspection，Inspection plan should be formulated，Clear inspection standard，Record the on -site inspection situation，Inform the inspection results of the inspection results。It needs rectification，The rectification content and rectification period should be clearly clarified，Cut Tracking Examination。

Article 54 The food and drug supervision and management department shall strengthen the spot check and inspection of medical equipment。
Food and drug supervision and management departments above the provincial level shall promptly issue the quality announcement of the medical device in accordance with the random inspection and inspection conclusion。

Article 55 of the complaint report or other information display, and daily supervision and inspection found that there may be medical device production enterprises that may have hidden dangers of product safety，or medical device manufacturers with bad behavior records，Food and Drug Supervision and Management Department can implement flight inspections。

Article 56 There is one of the following situations，Food and Drug Supervision and Management Department may interview the legal representative or person in charge of medical device manufacturers:
(1) There are serious safety hazards in production;
(2) Production products have been reported to complaints or media exposure due to quality problems;
(3) The credit rating is evaluated as a bad credit enterprise;
(4) The food and drug supervision and management department believes that it is necessary to carry out other circumstances for responsibility interviews。

Article 57 The local food and drug supervision and management departments at all levels shall establish a regulatory file for medical device manufacturers in this administrative regional regional regional。Supervision files shall include product registration and filing of medical device manufacturers、Production license and filing、commissioned production、Supervision and inspection、Spring inspection inspection、Monitoring of bad events、Product Recall、Information such as bad behavior records and complaint reports。

Article 58 The State Food and Drug Administration establishes a unified medical device production supervision and management information platform，Food and drug supervision and management departments at all levels should strengthen information construction，Guarantee information connection。

Article 59 The local food and drug supervision and management departments at all levels shall be based on the relevant records of supervision and management of medical device manufacturers，Credit evaluation of medical device manufacturers，Create credit files。Enterprises with bad credit records，The frequency of inspection should be added。
Enterprises included in the "blacklist"，Implement in accordance with the relevant provisions of the State Food and Drug Administration。

Article 60 Personal and Organizations found that medical device manufacturers conduct illegal production activities，I have the right to report to the food and drug supervision and management department，Food and Drug Supervision and Management Department shall verify it in time、Treatment。verified that it is true，Rewards shall be given in accordance with relevant regulations。

Chapter 6 Legal Responsibility

Article 61 with one of the following situations，Punishment in accordance with Article 63 of the Regulations on the Supervision and Administration of Medical Devices:
(1) The second category of production without medical device registration certificate、The third category of medical equipment;
(2) Class 2 without permission、The production activities of the third type of medical device;
(3) The second category of production exceeds the scope of production or is not consistent with the production product of medical device production products、The third category of medical equipment;
(4) Production in the second category of unauthorized production venues、The third category of medical equipment;
(5) The second category、The third category of medical device entrustment after production is terminated，The trustees continue to produce trusted products。

Article 62 "Medical Device Production License" expires after the validity period,No continuation of it in accordance with the law，Still continuing to engage in medical equipment production,In accordance with the provisions of Article 63 of the Regulations on the Supervision and Administration of Medical Devices。

Article 63 Provide false information or take other deception methods to obtain the "Medical Device Production License"，Punishment in accordance with Article 64 of the Regulations on the Supervision and Administration of Medical Devices。

Article 64: The production activities engaged in the first type of medical device did not record it to the food and drug supervision and management department in accordance with regulations，Punishment in accordance with Article 65 of the Regulations on the Supervision and Administration of Medical Devices;，Punishment in accordance with Article 65 of the Regulations on the Supervision and Administration of Medical Devices。

Article 65 forgery、STC、Sale、rental、Dedicated "Medical Device Production License"，Punishment in accordance with Article 64 of the Regulations on the Supervision and Administration of Medical Device。
Forgery、STC、Sale、rental、Discipline of medical device production filing vouchers，Food and drug supervision and management department at or above the county level ordered correction，penalties below 10,000 yuan。

Article 66 There is one of the following situations，Punishment in accordance with Article 66 of the Regulations on the Supervision and Administration of Medical Device:

(1) Production of medical devices that do not meet mandatory standards or do not meet the registered or recorded product technical equipment;
(2) Medical device manufacturers have not followed the registration、Product technical requirements for the recorded product requirements，Or that the quality management system is not established in accordance with the provisions of these Measures and maintains effective operation;
(3) Entrusted enterprises that do not have the conditions stipulated in these Measures to produce medical devices or do not manage the production behavior of the trustee。

Article 67 The production conditions of medical device manufacturers have changed、No longer meets the requirements of the quality management system of medical equipment，No rectification in accordance with the requirements of these Measures、Stop production、Report，Punishment in accordance with Article 67 of the Regulations on the Supervision and Administration of Medical Devices。

Article 68 of the medical device manufacturer fails to provincial、Autonomous Region、Municipal food and drug supervision and management departments in municipalities or districts submitted the self -examination report of the operation of the enterprise's quality management system，Punishment in accordance with Article 68 of the Regulations on the Supervision and Administration of Medical Devices。

Article 69 There is one of the following situations，Alerts by the food and drug supervision and management department at or above the county level，Order to correct the time limit，It can be fined below 30,000 yuan:
(1) The medical device from the factory does not test it in accordance with regulations;
(2) If the factory medical device is not attached to the document in accordance with regulations;
(3) Failure to handle the "Medical Device Production License" change registration in accordance with Article 16 of these Measures;
(4) Those who fail to complete the commissioned production filing procedures in accordance with regulations;
(5) Medical equipment products have been discontinued for more than one year and no similar products are produced，Unrepaired province、Autonomous Region、Municipal -level food and drug supervision and management departments in municipalities or districts to verify that they meet the requirements and resume production;
(6) conceal the relevant situation to the food and drug supervision and management department of supervision and inspection、Provide false information or refuses to provide real information that reflects its activities。
The situation listed in the previous paragraph，The plot is serious or causes the consequences of harm，It belongs to the relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices"，Punishment in accordance with the "Regulations on the Supervision and Administration of Medical Devices"。

Chapter 7 Attachment

Article 70 of the production of export medical equipment，It should be guaranteed that the medical equipment that it produces meets the requirements of importing countries (regions)，And the product -related information will be filed with the city -level food and drug supervision and management department where the local area is located。
Production enterprises accept medical devices that are commissioned by overseas enterprises to commission the production of medical devices sold abroad，The third -party certification of the medical equipment quality management system should be obtained or the domestic production license or filing of similar products。

71st "Medical Device Production License" and the format of the first type of medical device production filing certificate are formally formulated by the State Food and Drug Administration。
"Medical Device Production License" is provincial、Autonomous Region、Printing for the food and drug supervision and management department of municipality directly under the Central Government。
The arrangement of the "Medical Device Production License" number is: XXXXXXXX number。Where:
The first place X represents the province where the license department is located、Autonomous Region、Abbreviation of municipalities directly under the Central Government;
The second to five x represents the year of the 4 -digit permit;
Sixth to 9th x represents 4 digits permit flow.
The arrangement of the filing number of the first category of medical device production filing vouchers is: XX Food Drug Supervisor Production Preparation xxxxxxxx number。Where:
The first place X represents the place where the filing department is located、Autonomous Region、Abbreviation of municipalities directly under the Central Government;
The second X represents the abbreviation of municipal administrative areas where the record area is located;
Sixth to sixth X represents 4 digits record year;
Seventh to 10 X represents the 4 -digit filing flow.

Article 72 The medical device production license electronic certificate produced by the food and drug supervision and management department has the same legal effect as the printed medical device production license。

Article 73 This Measures will be implemented from October 1, 2014。The "Measures for the Supervision and Management of Medical Device Production Supervision" released on July 20, 2004 (National Food and Drug Administration Order No. 12)。