UK Medical Device Regulation QA

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E-mail: lon4ww@evershinecpa.com
Ms. Anny Lin, speak both English and Chinese.
WeChat: annylin8008
Skype: annylin8008

2023/09/08  drafted by Yvonne Chen

HLF-TW-10
What are the categories of medical devices in The United Kingdom? What is its official name? What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?
Evershine RD：

In the UK, medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).
A medical device is defined as any device, appliance, software, material or other article manufactured for the purpose of providing medical treatment to humans, whether used alone or in combination. Medical devices include in vitro diagnostic medical devices and active implantable medical devices that are implanted in the patient’s body and require an external power source.

1. Medical device grade: (depending on the risk to the human body)
2. Class I: wheelchairs, glasses, stethoscopes, tongue depressors, etc.
3. Class IIa: dental fillings, surgical clips, tracheotomy tubes, etc.
4. Class IIb: condoms, lung ventilators, bone fixation plates, etc.
5. Class III: pacemakers, heart valves, implantable brain stimulators, etc.
6. Classification of medical device:
7. Non-invasive: device that does not enter the human body, such as plasters, canes, wheelchairs, artificial kidneys (extracorporeal dialysis), etc.
8. Invasive: Devices inserted into body orifices, such as contact lenses, enemas, examination gloves, etc.
9. Surgical invasiveness: devices used or inserted during surgery, such as needles, scalpels, cardiovascular catheters, etc.
10. Active: device that requires external power supply, such as X-ray, ultrasound, TENS, etc.
11. Implantable: Devices implanted in the body, such as breast implants, orthopedic implants, intraocular lenses, etc.

【Reference link】
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview#what-a-medical-device-is

HLF-TW-20
If a foreign company wants to sell medical devices in The United Kingdom, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
No business license.

【Reference link】
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market

HLF-TW-25

HLF-TW-30
If a foreign company wants to sell medical devices in The United Kingdom, can it assign a The United Kingdom company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
Yes, the medical device regulations do not specifically regulate the conditions for business agents.

Product Safety
Responsibility for the product rests with the manufacturer and the UK responsible person first. Manufacturers need to bear any legal liability arising from adverse events in medical devices placed or supplied to the UK market; UK responsible persons carry out responsibilities related to manufacturer obligations on behalf of non-UK manufacturers, but companies that import, distribute or sell medical devices Everyone must be responsible for safety and cooperate with improvement measures.

【Reference link】
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#post-market-surveillance-and-vigilance

HLF-TW-35

HLF-TW-40
Do foreign companies need to apply for an approval before importing medical devices sold to The United Kingdom? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：

Yes, medical device product registration needs to be completed.
All medical devices marketed in the UK, including IVDs, custom-made devices and systems or software programs, must be registered with the MHRA before they can be placed on the UK market.

1. Application qualifications:
2. The manufacturer needs to register the product. If the manufacturer is located outside the UK, it must appoint a UK responsible person to be responsible for all its medical equipment. The UK responsible person must provide written proof of authorization.
3. The importer or distributor can act as the UK responsible person at the same time.
4. UR : https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration
5. Basic information:
6. Manufacturer details
   ． Legal entity name and address on device label/packaging
   ． Company type, such as limited company, sole proprietorship
   ． Manage contacts (up to 15 people permissions).
   ． Legal power of attorney from the UK Responsible Person (if applicable) stating the sole UK Responsible Person acting on behalf of the manufacturer and the mandatory tasks undertaken on behalf of the manufacturer
7. Device details
   ．Device category
   ．UDI-DI (if applicable)
   ．Medical Device Name (Brand/Commodity/Proprietary Name)
   ．Model or version
   ．Catalog/reference number
   ．UK Accreditation Body (or EU Notified Body) (if applicable)
   ．Sterile, latex-containing, MRI and other properties
   ．Copy of conformity assessment certificate or self-certification declaration of conformity (if applicable)
8. Fees: There is a statutory fee of £240 for each registration.
9. Validity period: The first application date is 1 year after the MHRA completes the account, and it must be renewed at least every 2 years thereafter.

Label

1. The name or trade name and address of the manufacturer (if the manufacturer has no place of registration, the name and address of the responsible person in the UK should be included)
2. Sterility identification (if applicable)
3. Lot code (LOT) or serial number
4. Indicate the safe use period in years and months
5. Single-use identification (if applicable)
6. Identification of customized device (if applicable)
7. Identification specifically used for clinical research (if applicable)
8. Any special storage and/or handling conditions
9. Any special operating instructions
10. Any warnings and/or precautions to be taken
11. Sterilization method (if applicable)
12. Identification of products containing human blood derivatives (if applicable)
13. If the intended use of the device is not obvious to the user, the manufacturer must clearly state this on the label and instructions for use
14. Performance and any adverse side effects
15. If the device must be installed or connected with other medical devices or device, sufficient details of its characteristics should be provided
16. Method and frequency of maintenance and correction
17. Re-sterilization method when the sterile packaging is damaged
18. If the device is reusable, any restrictions on the reuse process, including cleaning, disinfection, packaging, and sterilization methods and number of reuses for the device that are re-sterilized
19. Detailed information on the nature, type, intensity and distribution of radiation (if applicable)
20. Detailed information on contraindications and precautions to be taken
21. Precautions to be taken when exposed to magnetic fields, external electrical influences, electrostatic discharges, pressure or changes in pressure, acceleration, hot ignition sources, etc.
22. Date of issue or latest version of the instructions for use
23. Labels should be in English.

【Reference link】
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#responsible
https://www.legislation.gov.uk/uksi/2002/618/contents/made

HLF-TW-45

HLF-TW-50
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
No. Product licenses application needs to be made by the manufacturer or his authorized UK responsible person.

All medical devices marketed in the UK, including IVDs, custom-made devices and systems or software programs, must be registered with the MHRA before they can be placed on the UK market.

1. Application qualifications:
   1.The manufacturer needs to register the product. If the manufacturer is located outside the UK, it must appoint a UK responsible person to be responsible for all its medical equipment. The UK responsible person must provide written proof of authorization. 2.The importer or distributor can act as the UK responsible person at the same time.
2. UR: https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration
3. Basic information:
   1.Manufacturer details
   ． Legal entity name and address on device label/packaging
   ． Company type, such as limited company, sole proprietorship
   ． Manage contacts (up to 15 people permissions).
   ． Legal power of attorney from the UK Responsible Person (if applicable) stating the sole UK Responsible Person acting on
   　behalf of the manufacturer and the mandatory tasks undertaken on behalf of the manufacturer
   2.Device details
   ．Device category
   ．UDI-DI (if applicable)
   ．Medical Device Name (Brand/Commodity/Proprietary Name)
   ．Model or version
   ．Catalog/reference number
   ．UK Accreditation Body (or EU Notified Body) (if applicable)
   ．Sterile, latex-containing, MRI and other properties
   ．Copy of conformity assessment certificate or self-certification declaration of conformity (if applicable)
4. Fees: There is a statutory fee of £240 for each registration.
5. Validity period: The first application date is 1 year after the MHRA completes the account, and it must be renewed at least every 2 years thereafter.

Label

1. The name or trade name and address of the manufacturer (if the manufacturer has no place of registration, the name and address of the responsible person in the UK should be included)
2. Sterility identification (if applicable)
3. Lot code (LOT) or serial number
4. Indicate the safe use period in years and months
5. Single-use identification (if applicable)
6. Identification of customized device (if applicable)
7. Identification specifically used for clinical research (if applicable)
8. Any special storage and/or handling conditions
9. Any special operating instructions
10. Any warnings and/or precautions to be taken
11. Sterilization method (if applicable)
12. Identification of products containing human blood derivatives (if applicable)
13. If the intended use of the device is not obvious to the user, the manufacturer must clearly state this on the label and instructions for use
14. Performance and any adverse side effects
15. If the device must be installed or connected with other medical devices or device, sufficient details of its characteristics should be provided
16. Method and frequency of maintenance and correction
17. Re-sterilization method when the sterile packaging is damaged
18. If the device is reusable, any restrictions on the reuse process, including cleaning, disinfection, packaging, and sterilization methods and number of reuses for the device that are re-sterilized
19. Detailed information on the nature, type, intensity and distribution of radiation (if applicable)
20. Detailed information on contraindications and precautions to be taken
21. Precautions to be taken when exposed to magnetic fields, external electrical influences, electrostatic discharges, pressure or changes in pressure, acceleration, hot ignition sources, etc.
22. Date of issue or latest version of the instructions for use
23. Labels should be in English.

【Reference link】
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#responsible
https://www.legislation.gov.uk/uksi/2002/618/contents/made

HLF-TW-55

HLF-TW-60
What documents are required when importing approved medical devices into The United Kingdom? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：

Medical devices with product registration can be imported into the UK for sale.
Import process:

1. Economic Operator Registration and Identification Number (EORI Number): If the business is located in the country/region where the goods are to be shipped into or out of, it needs to obtain an EORI number first.
   ．Businesses generally need to have a place of business in the country of import or export. The place must be one of the following: registered office, central headquarters, permanent business establishment.
   ．If you are not eligible to apply for an EORI number yourself, you will need to appoint someone to represent you in customs matters.
2. Apply for the simplified import declaration form
   URL: https://www.gov.uk/topic/business-tax/import-export
   ．Summary of Supplementary Statements
   ．Use simplified declarations
   ．Use the declarant record
   ．Apply for authorization on behalf of a third party
   ．MHRA license certificate
3. Import declaration form (all goods imported from outside the UK must be declared to UK customs.)
   ．Company Economic Operator Registration and Identification Number (EORI)
   ．Company VAT number
   ．Import reason
   ．Product description
   ．Tariff number/commodity code
   ．Value of goods
   ．Any import controls that may apply
   4.Have information
   ．Commercial invoice or shipping invoice
   ．Shipping documents (e.g. bill of lading, air waybill, etc.)
   ．Packing List
   ．Insurance certificate/policy
   ．Commodity code
   ．Tariff valuation
   ．Purchase Order/Contract
   ．Customs entry documents
   ．Freight forwarder or carrier invoice
   ．Additional certificate

No sales notice.
【Reference link】
https://www.gov.uk/government/collections/guidance-for-exporting-and-importing-businesses

HLF-TW-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
UKCA
1.The UKCA (UK Conformity Assessment) mark is a British product mark used for medical devices placed in the British market (England, Wales and Scotland).
2.The UKCA mark requires third-party conformity assessment by a British approval agency. However, manufacturers of non-sterile and non-measuring Class I devices, as well as IVDs in general, can self-certify under the UKCA mark.
3.Class I equipment: An application to an accreditation body for conformity assessment is required to approve the declaration. Assessment types can be the following
．Inspection and testing of each product or homogeneous batch of products
．Production quality assurance system audit.
．Review of final inspection and testing
．Comprehensive quality assurance system audit
4.Class IIb equipment: one of the following certifications must be performed
．Audit of complete quality assurance system
．Type examination plus options given above for class IIa equipment
5.Class III equipment: one of the following certifications must be performed
．Audit of complete quality assurance system, including design file inspection
．Type examination plus options given above for class IIa equipment
6.Comply with specified standards: ISO 13485
7.Clinical research

【Reference link】
https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ukca-mark

HLF-TW-75

HLF-TW-77

HLF-TW-80
After a foreign subsidiary imports medical devices and entrusts a distributor in The United Kingdom to sell it, does the distributor need a medical devices business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：

Business license is not required.

Product Safety
Responsibility for the product rests with the manufacturer and the UK responsible person first. Manufacturers need to bear any legal liability arising from adverse events in medical devices placed or supplied to the UK market; UK responsible persons carry out responsibilities related to manufacturer obligations on behalf of non-UK manufacturers, but companies that import, distribute or sell medical devices Everyone must be responsible for safety and cooperate with improvement measures.

【Reference link】
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#post-market-surveillance-and-vigilance

HLF-TW-85

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E-mail: lon4ww@evershinecpa.com
Ms. Anny Lin, speak both English and Chinese.
WeChat: annylin8008
Skype: annylin8008

or
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