CERTIFICATION IN INDIA

UKCA MARK CERTIFICATION

What is UKCA Mark Certification?

The United Kingdom Conformity Assessment Mark or UKCA Mark for short is the UK equivalent of the EU CE marking. UKCA Mark is a valid indicator that a medical device conforms to relevant UK Regulations. The United Kingdom Conformity Assessment (UKCA) marking is mandatory for medical devices sold on the market in Great Britain (England, Wales, and Scotland).

United Kingdom’s Medicines and Health Care products Regulatory Agency (MHRA) On 18 September 2019, published new guidelines to regulate medical devices after Brexit. The UKCA will not be recognized in the EU, EEA, or Northern Ireland and products still require a CE marking for sale in these markets.

The manufacturer or their authorized representative will be responsible for affixing the UKCA mark to the product, which is the same principle as for CE marking but for the UK market.

Benefits of UKCA Mark Certification

Sell your product in the countries of the European Economic Area

Reduce the risk of customer dissatisfaction

Make Trading Easier

Improve Product Credibility

Ensure Product Safety

Increase Market size

Who can be certified UKCA Mark Certification?

Most products that are currently covered under regulations and directives for CE marking will fall under the scope of UKCA marking.

Shamkris Group

Medical Devices

Shamkris Group

Machinery

Shamkris Group

Lifts

Shamkris Group

Measuring Instruments

Shamkris Group

Safety of Toys

Shamkris Group

Construction Products

Shamkris Group

Personal Protective Equipment

Shamkris Group

Electronics

Shamkris Group

LED Lighting Products

Shamkris Group

Electrical

Shamkris Group

Mobile Equipment

Shamkris Group

Computers

Shamkris Group

Wrist Watches

Shamkris Group

IVD Testing

Document required for UKCA Mark Certification

The extent of Documented Information differs as per:

Role of Shamkris and Process of UKCA Mark Certification

Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives. 

The implementation process is described below:

Time Frame

Task

Process

Day 1

Scope defined
Self Certification/NoBo/MHRA
Selection
Cost Estimates

Week 1

Developing Documents

Week 4

Implementing Product Management System

Week 8

Internal Audit
MRM
CAPA

Week 10

Self Certification/NoBo/MHRA
Audit
N-C Closing

Week 12

Self Certification/NoBo/MHRA

Year on Year

Yearly Compliance

FAQ

UKCA marking (UK Conformity Assessed marking) is the proposed UK product marking requirement that will be needed for products being placed on the UK market, substituting the EU requirements for CE Marking.

The UKCA marking applies to most goods previously subject to the CE marking. … In some cases, you need to apply the new UKCA marking to goods being sold in Great Britain immediately from 1 January 2021. The CE marking is only valid in Great Britain for areas where GB and EU rules remain the same.