| Medical Device Quality Managment System (QMS) | |
| Medical Device Importer entering Taiwan Market | |
| For foreign manufacturer out of Taiwan, it is necessary to prove that the Quality management system of the physical manufacturer is in compliance with Taiwan Medical Device Quality Managment System Regulations (effective on May 1, 2021) and getting QSD number before the product approval is granted. The manufacturer may provide QMS documentation according to ISO 13485:2016 for review instead of overseas on site inspection. However, for manfuacturer who produce certain high risk invasive medical devices published on TFDA website, it is mandatory to conduct oversease on-site inspection. There is a fast track to get QSD for manufacturer located in EU member state, Swiss, US and Japan
The term "medical device dealers", as used in this Act, shall refer to businesses which engage in the wholesale, retail, import, export, rental, or repair of medical devices. |
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| Before applying QSD, it is necessary to appoint one license holder in Taiwan. | |
| Domestic Medical Device Manufacturer in Taiwan | |
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For domestic manfuacturer in Taiwan, it is necessry to establish Quality Managment System in complinace with Medical Device Quality Management System Regulation and medical device Act.
Taiwan Medical Device Quality Management System Regulation is effective on May 1st, 2021. Article 10 The term "medical device manufacturers", as used in this Act, shall refer to businesses that fall into the following two types: 1. Engaging in the manufacturing, packaging, labeling, sterilization, or final inspection and release of medical devices. 2. Engaging in the design of medical devices and marketing the devices under their name. |
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| Medical Device Technicians responsible for Regulation complaince | |
| Article 15 Medical device manufacturers and dealers engaging in the import or repair shall employ qualified technicians... |
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| The QSD letter or QMS approval should be renewed every 3 years. | |
Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
The FDA is responsible for assuring medical devices available in the United States are safe and effective throughout their total product lifecycle.
The FDA has established Quality System Regulations (QSR) addressing device design and validation as well as good manufacturing practices.
The FDA’s regulations also address complaint investigations and other means of surveilling device performance.
The FDA seeks to harmonize its requirements for a Quality Management System (QMS) with internationally recognized regulatory requirements for Quality Management System (QMS) for devices, ISO 13485, which is used by many other regulatory authorities.
US FDA conduct on site inspections.
Establishment registration and listing
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.), including those that are imported for export only, are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment (Title 21 CFR Part 807).
The requirements for registration and listing are based on the type of activity performed at that establishment.
please visit US FDA website (Who Must Register, List and Pay the Fee) for type of activities require payment of the establishment registration fee.
- Domestic establishments: manufacturer, contract manufactrurer, contract sterilizer, relabeler, repackager, specification developer, reprocessor...
- Foreign establishments: manufacturer, contract manufactrurer, contract sterilizer, relabeler, repackager, specification developer, reprocessor... All establishments required to register must pay the user fee prior to completing their registration.
Annual Registration
Registration information must be submitted each year between October 1 and December 31, even if no changes have occurred.
Listing information must be reviewed each year between October 1 and December 31, at the same time you review your registration information.
Submit any updates at that time.
Initial Registration
Submit registration and /or listing information within 30 days of an establishment beginning an activity or putting a device into commercial distribution.
Foreign establishments must register before exporting products to the United States and domestic importers must register before importing products.
Reminder that if your device requires premarket notification clearance or approval, you will have to wait until your premarket submission [510(k), PMA, etc.] is cleared or approved to register your establishment and list the device.
Update Registration & Listing Information
All owners or operators can access FURLS at any time throughout the year to update changes to their registration and listing information as those changes occur.
Examples of changes to listings include:
- another device being introduced into commercial distribution,
- a change to a previously listed device, such as where it is being manufactured,
- a previously-listed device is removed from commercial distribution or commercial distribution is resumed.
Establishment registrations are based on FDA’s fiscal year which runs from October 1 to September 30.
FDA will continue to consider an establishment’s registration active through the end of each calendar year.
part 820 _Quality system regulation_CFR
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
Subpart A--General Provisions
§ 820.1 - Scope.
§ 820.3 - Definitions.
§ 820.5 - Quality system.
Subpart B--Quality System Requirements
§ 820.20 - Management responsibility.
§ 820.22 - Quality audit.
§ 820.25 - Personnel.
Subpart C--Design Controls
§ 820.30 - Design controls.
Subpart D--Document Controls
§ 820.40 - Document controls.
Subpart E--Purchasing Controls
§ 820.50 - Purchasing controls.
Subpart F--Identification and Traceability
§ 820.60 - Identification.
§ 820.65 - Traceability.
Subpart G--Production and Process Controls
§ 820.70 - Production and process controls.
§ 820.72 - Inspection, measuring, and test equipment.
§ 820.75 - Process validation.
Subpart H--Acceptance Activities
§ 820.80 - Receiving, in-process, and finished device acceptance.
§ 820.86 - Acceptance status.
Subpart I--Nonconforming Product
§ 820.90 - Nonconforming product.
Subpart J--Corrective and Preventive Action
§ 820.100 - Corrective and preventive action.
Subpart K--Labeling and Packaging Control
§ 820.120 - Device labeling.
§ 820.130 - Device packaging.
Subpart L--Handling, Storage, Distribution, and Installation
§ 820.140 - Handling.
§ 820.150 - Storage.
§ 820.160 - Distribution.
§ 820.170 - Installation.
Subpart M--Records
§ 820.180 - General requirements.
§ 820.181 - Device master record.
§ 820.184 - Device history record.
§ 820.186 - Quality system record.
§ 820.198 - Complaint files.
Subpart N--Servicing
§ 820.200 - Servicing.
Subpart O--Statistical Techniques
§ 820.250 - Statistical techniques.
The quallity managment system should be compliant with New Regulation set forth in April 2017
What is the content of PD CEN/TR 17223:2018? This standard PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation. This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes. |
| MDR 2017/745 Article 10 Genral obligations of manfuacturers |
General speaking, the quality managment system requirement are described in MDR 2017/745 Ariticle 10.
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| Conformity assessment |
| according to MDR 2017/745 Article 52 Conformity assessment procedures |
| 7. Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declartion of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III. if those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI. However, the involvement of the notified body in those procedures shall be limited. |
| PRRC appointment |
| Article 15 Person Responsible for regulatory compliance (PRRC) |
| the manufactures shall have available within their orgnaizaiton at least one person responsible for regulatory comliance who possesses the requistie expertise in the field of medical devies. |
Health Canada |
| Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system. The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on January 1, 2003. All manufacturers of class II, III, and IV medical devices holding licences or applying for new or amended licences must complete the transition to ISO 13485:2016 by March 1st, 2019. |
| Medical Device Single Audit Program (MDSAP) |
Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP). All manufacturers holding medical device licences in Canada now participate in the program, which improves Health Canada's oversight of the medical devices sold in Canada, and ensures that the medical devices Canadians use meet higher quality standards. The transition to the MDSAP was initially announced in December 2015 and was completed in 2019. |
| Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars |
| List of Registrars Recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR) December 18, 2014 |
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Medical Device Quality Managment System (QMS)
Medical Device Importer entering Taiwan Market
For foreign manufacturer out of Taiwan, it is necessary to prove that the
Quality management system of the physical manufacturer is incompliance with Taiwan Medical Device Quality Managment System Regulations
(effective on May 1, 2021) and getting QSD number before the productapproval is granted. The manufacturer may provide QMS documentation
according to ISO 13485:2016 for review instead of overseas on siteinspection. However, for manfuacturer who produce certain high risk
invasive medical devices published on TFDA website, it is mandatory toconduct oversease on-site inspection.
There is a fast track to get QSD for manufacturer located in EU member state,Swiss, US and Japan
• EU memeber states, Swiss Fürstentum Liechtenstein could provide
Free sale certificate and audit report via TCP III program from TFDArecognized NB.
• US manufacturer could provide EIR or MDSAP audit report and CFG.
• Japan manufacturer could provide QMS audit report from PMDA or RCBs
audit report and QMS complinace cerificate.Article 11
The term "medical device dealers", as used in this Act, shall refer to businesseswhich engage in the wholesale, retail, import, export, rental, or repair of
medical devices.
Before applying QSD, it is necessary to appoint one license holder in Taiwan.Domestic Medical Device Manufacturer in Taiwan
For domestic manfuacturer in Taiwan, it is necessry to establish Quality Managment System in complinace with Medical Device Quality Management System
Regulation and medical device Act. Taiwan Medical Device Quality Management System Regulation is effective on May 1st, 2021.
Article 10
1. Engaging in the manufacturing, packaging, labeling, sterilization, or final inspection and release of medical devices.
2. Engaging in the design of medical devices and marketing the devices under their name.Medical Device Technicians responsible for Regulation complaince
Article 15
Medical device manufacturers and dealers engaging in the import or repair shall employ qualified technicians...
The QSD letter or QMS approval should be renewed every 3 years.