Service Schemes for Medical Device Export to
the European Market
If you are a medical device manufacturer/trader wanting to produce and sell medical devices domestically in accordance with regulations, we provide you with the following service schemes:
1. Medical device manufacturer (production-oriented enterprise)
· Class I medical devices - handle the product recording certificate and production recording certificate
· Class II/III medical devices - handle the product registration certificate and production license
· Assist in establishing a medical device quality management system in accordance with GMP
2. Medical device trader (trade-oriented enterprise)
· Class II medical devices - handle the operation recording certificate
· Class III medical devices - handle the operation license
· Assist in establishing a medical device operation management system in accordance with GSP
I. For medical device manufacturers (production-oriented enterprises)
1. Medical device recording/registration classification
According to the Regulations for the Supervision and Management of Medical Devices (Order No. 650 of the State Council), medical devices within the territory of the People’s Republic of China shall be subject to classification management based on the risk level. There are three classes, namely, Class I, Class II and Class III.
Recording/registration classification
Device class | Recording or registration | Accepting institution | Certificate validity period | Handling time (working day) |
Class I | Recording | Municipal food and drug administration departments of the cities with subordinate districts | Permanent | Recording on the spot |
Class II | Registration | Food and drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government | 5 years | 3 days Accepting institution->review center 60 days Review center->accepting institution 20 days Accepting institution->applicant 10 days Certificate issuance by the accepting institution |
Class III | Registration | China Food and Drug Administration | 5 years | 3 days Accepting institution->review center 90 days Review center->accepting institution 20 days Accepting institution->applicant 10 days Certificate issuance by the accepting institution |
2. Medical device production recording/production license
Production recording/production license
Device class | Production recording or production license | Accepting institution | Certificate Validity period | Handling time (working day) | Basis of on-site audit |
Class I | Production recording | Local municipal food and drug administration departments under the people’s governments of the cities with subordinate districts | Permanent | Recording on the spot | / |
Class II | Production license | Local food and drug administration departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government | 5 years | 30 days Audit by the accepting institution 10 days Certificate issuance | Good Manufacturing Practice (No. 64 of 2014) |
Class III | Production license | Local food and drug administration departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government | 5 years | 30 days Audit by the accepting institution 10 days Certificate issuance | Good Manufacturing Practice (No. 64 of 2014) |
3. Process and cycle of medical device recording/registration & production recording/production license
Process of the first recording of Class I medical devices
Class I medical devices bear low risks, and the routine management can ensure their safety and effectiveness. Domestic manufacturers need to record with local municipal food and drug administrations of the cities with subordinate districts, and overseas medical device manufacturers need to entrust their agents in China to record with the NMPA.
Normally, the recording cycle is 30 working days. If rectification materials are to be provided, the time will be calculated separately.
Process of the first registration of Class II/III medical devices
Class II medical devices bear medium risks, and strict control and management are required to ensure their safety and effectiveness. Domestic manufacturers need to register with local food and drug administrations at the province (municipality directly under the Central Government) level, and overseas medical device manufacturers need to entrust their agents in China to register with the NMPA.
Class III medical devices bear high risks, for which special measures need to be taken to strictly control and manage them, so as to ensure their safety and effectiveness. Both domestic and foreign medical device manufacturers must be registered with the NMPA.
Normally, the registration cycle is 240 working days. If rectification materials are to be provided, the time will be calculated separately.
Perform the on-site system assessment
Device class | Quality management system Assessing institution | Finishing time (working day) | Basis of assessment |
Class I | / | / | / |
Class II | Food and drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government | 30 days | Measures for Quality System Assessment of Medical Device Manufacturers (NMPA No. 22) |
Class III | Food and drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government (NMPA issues the notice and participates when necessary) | 30 days | Measures for Quality System Assessment of Medical Device Manufacturers (NMPA No. 22) |
4. GMP quality system
· Basis:
Measures for the Supervision and Administration of Medical Device Production (Order No. 7 of the China Food and Drug Administration)
Good Manufacturing Practice (No. 64 of 2014)
· Guidelines
218-1 On-site Inspection Guidelines
218-2 On-site Inspection Guidelines for Sterile Medical Devices
218-3 On-site Inspection Guidelines for Implantable Medical Devices
218-4 On-site Inspection Guidelines for In Vitro Diagnostic Reagents
Good Manufacturing Practice - On-site Inspection Guidelines for Customized Dentures
· Guides
Guide for Quality Management of Process Water for Medical Devices
Guide for Audit of Suppliers of Medical Device Manufacturers
Annual Self-inspection Report on Quality Management System of Medical Device Manufacturers
Risk List and Key Inspection Points in the Production Process of 21 Kinds of Medical Devices such as Disposable Plastic Blood Bags
Risk List and Key Inspection Points in the Production Process of 25 Kinds of Medical Devices such as Disposable Sterilized Syringes
Guide for Quality Control and Finished Product Release of Medical Device Manufacturers
· Process and cycle of assisting the establishment of GMP quality system
1) Perform a gap analysis for the enterprise according to GMP requirements, and make a rectification plan;
2) Guide the enterprise to rectify according to the rectification plan and check the rectification condition;
3) Assist and guide the enterprise to prepare relevant system files and records;
4) Train relevant personnel;
5) Guide the enterprise to prepare for the audit, and assist the enterprise in rectifying the nonconforming items found in the audit.
Usually the system establishment cycle is 60 working days.
II. For medical device traders (trade-oriented enterprises)
1. Operation recording/license
Device class | Operation recording or license | Accepting institution | Certificate Validity period | Handling time (working day) | Basis of on-site audit |
Class I | No recording or license is required | / | / | / | / |
Class II | Recording | Local municipal food and drug administration departments of the cities with subordinate districts | Permanent | Recording on the spot | Within 3 months Good Supply Practice (No. 58 of 2014) |
Class III | License | Local municipal food and drug administration departments of the cities with subordinate districts | 5 years | 30 days Audit by the accepting institution 10 days Certificate issuance | Good Supply Practice (No. 58 of 2014) |
2. Process and cycle of medical device operation recording/license
Process and cycle of operation recording
1) Submit the application and relevant materials. The food and drug administration department checks whether the application materials meet the basic requirements, and handles the recording on the spot if the materials meet the requirements.
Normally, the recording cycle is 30 working days. If rectification materials are to be provided, the time will be calculated separately.
Process and cycle of handling the license
1) Submit the application and relevant materials. The food and drug administration department checks whether the application materials meet the basic requirements and decides whether to accept or reject the application.
2) Conduct on-site audit. The food and drug administration department appoints one to three auditors to audit the operation site of the enterprise. If the enterprise fails to meet the requirements, the auditor may require the enterprise to make rectification. If the enterprise still fails to meet the requirements after rectification, a notice of disapproval will be given.
3) Issue the certificate. The food and drug administration department decides whether to issue the operation license to the enterprise according to the relevant materials, and publishes the relevant information of the enterprise on the relevant website. If there is no objection after the publicity, it will inform the enterprise to obtain the medical device operation license.
Quotation principle for operation recording/license
Normally, the license handling cycle is 60 working days. If rectification materials are to be provided, the time will be calculated separately.
3. GSP quality system
· Basis:
Measures for the Supervision and Management of Medical Device Operation (Order No. 8 of the China Food and Drug Administration)
Good Supply Practice (No. 58 of 2014)
· Guideline:
Good Supply Practice - On-site Inspection Guidelines
· Guide:
Guide for Management of Medical Device Cold Chain (Transportation and Storage)
· Process and cycle of assisting the establishment of GSP quality system
1) Perform a gap analysis for the enterprise according to GSP requirements, and make a rectification plan;
2) Guide the enterprise to rectify according to the rectification plan and check the rectification condition;
3) Assist and guide the enterprise to prepare relevant system files and records;
4) Train relevant personnel;
5) Guide the enterprise to prepare for the audit, and assist the enterprise in rectifying the nonconforming items found in the audit.
Usually the system establishment cycle is 30 working days.
Quotation Scheme for Medical Device
Export to the European Market
Quotation principles for medical device product recording certificate and production recording certificate:
The charge for handling the medical device recording certificate is divided into technical service fee and administrative fee. The administrative fee is subject to the information published by the local food and drug administration, and the quotation principles for the technical service fee are as follows:
1) For the production recording certificate, usually one charge for one enterprise;
2) The quotation for product recording certificate is based on the number of products.
Quotation principles for medical device product registration certificate and enterprise production license:
The charge for handling the medical device product registration certificate and enterprise production license is divided into technical service fee and administrative fee. The administrative fee is subject to the information published by the local food and drug administration, and the quotation principles for the technical service fee are as follows:
1) For the enterprise production license, usually one charge for one enterprise;
2) The quotation for product registration certificate is based on the number of products.
Quotation principle for GMP system service
GMP counseling needs to be carried out on site, so the fee is charged according to the number of person-days. The factors that determine the number of person-days involved in the counseling include:
1) The scale of enterprise and the categories of medical devices produced;
2) Leveling of product risks;
3) The foundation of the enterprise itself, for example, whether it has passed ISO13485, and whether it has a documented management system.
Quotation principle for GSP system service
GSP counseling needs to be carried out on site, so the fee is charged according to the number of person-days. The factors that determine the number of person-days involved in the counseling include:
1) The scale of enterprise and the categories of medical devices sold;
2) Leveling of product risks;
3) The foundation of the enterprise itself, for example, whether it has passed ISO13485, and whether it has a documented management system.
