1. Providing the UKCA training course
SUNGO can provide a one-day course, introducing:
1) Market access requirements after Brexit;
2) Procedures and regulatory requirements for the UKCA certification;
3) Procedures for the MHRA registration and requirements for the UK Representative.
2. Providing the UKCA certification counseling
SUNGO can provide the counseling on technical documentation and system to meet the UKCA requirements, including:
1) Provide the technical documentation for low-risk products;
2) Provide the counseling on technical documentation and quality system for medium- and high-risk products;
3) Provide the upgrading and version change services based on the MDD/MDR document system.
3. Providing services as a UK Responsible Person
SUNGO UK has a long history of providing services as a European Authorized Representative, maintains good communication with the MHRA, and is able to provide services for customers as a UK Responsible Person in accordance with the UK MDR 2002 requirements.
As the UK Responsible Person, the following services will be provided for customers:
1) Sign bilateral agreements;
2) Complete the device registration for customers;
3) Provide the PMS liaison and communication services;
4) Maintain the technical documents and maintain the communication and liaison with the competent authorities.
4. Providing the MHRA registration services
SUNGO UK, as the regulatory responsible person of the enterprises, will complete the registration of all medical devices to be marketed in the UK with the MHRA on behalf of the enterprises.
Information required for the MHRA registration includes:
1) Application form;
2) Declaration of conformity;
3) Labels and instructions for use;
4) Test reports (where appropriate);
5) European Authorized Representative Agreement signed by both parties.