Regulatory Consulting

Manufacturers of medical devices need to produce technical documentation before putting their medical devices on to the European market. Technical Documentation is a sign of conformity with the relevant legislation. Technical documentation needs to be in compliance with the Medical Device Regulation (MDR) European Union (EU) Regulation 2017/745. The technical documentation represents the entirety of the documents describing a device including design, clinical evaluation and performance validation.  The technical documentation should be structured and presented, in such a way, as to facilitate its review and assessment by the NB (Notified Body). Its play a vital role during assessment of conformity by NB. Thus, a non- European manufacturer of medical has to submit the technical documentation to his EU Rep for verification before the CE mark is applied.  Antex Medi Solution as competent consultants, will assist you in preparing technical documentation of your product according to the requirements of MDR.     

ISO (International Organization for Standardization) is an independent, non-governmental international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems. ISO Certification is an approval from external certification body  that a company runs according to the internationally  recognised ISO management systems. ISO certification is Suitable for both small and large organisations. It provides better internal management system, produces less wastage, increase efficiently, identifies risk, improves customer retention and acquisition, increases productivity and profit. It helps you to reach in new market and to meet statutory and regulatory requirements. 

The Food and Drug Administration (FDA) is a government agency of United states of America that holds responsibility for monitoring the safe consumption of medical products, food, and tobacco items. You must need an approval from FDA before selling your products such as medical device, food, medicine, tobacco, and other items in USA market. It becomes more complicated to place the medical product in US market, especially with increasing requirements on manufacturers to meet changes in regulations. Antex Medi Solution can offer regulatory consultation to assist you in the process of: FDA Strategic Regulatory planning/classification,  FDA 510(k)/PMS build/submission,  Quality System Consulting (21 CFR Part 820),  FDA Pre-Submission meetings,  Pre IDE meeting – Preparation/participation,  Assistance with device listing/establishment registration.  Antex Medi Solution will provide you a cost effective support to ensure an effective outcome.   

The National Medical Products Administration/ NMPA (formerly the China Food and Drug Administration or CFDA) is regulatory agency of China, that holds the responsibility of regulating drugs and medical devices. NMPA is responsible for pre-market approvals and post-market supervision in the case of a medical device. If you are thinking of placing your product on the Chinese market, you must need an approval from NMPA. The NMPA has strict regulatory requirements, especially for foreign manufacturers who want to import their products to China. Thus you may need to understand an overview of the regulatory structure, the steps involved as well as the overview of in-country testing and clinical requirements before you begin the registration process. Antex Medi Solution will help you to understand these requirements and can help you obtain regulatory approval for your medical device.   

CE mark is a certificate that indicates the conformity of a product with health, safety and environmental protection with in the European Economic Area (EEA). CE marking recognizable in all over the world, even to those people who are not familiar with the European Economic Area. The CE marking is the declaration from manufacturer that the product meets EU standards for health, safety, and environmental protection. CE marking is an indication of that the product meets all the EU technical regulations requirement and can be circulated among the member states of the EU without facing any technical barriers. Antex Medi Solution will help you in the CE marking process or any aspect of product compliance.       

Customs Trade Partnership Against Terrorism (CTPAT) is an multi-layered cargo enforcement strategy of Customs and Border Protection (CBP). In this strategy CBP strengthen up the international supply chains by working with trade community as well as improve the border security of United State of America. CTPAT voluntary provides the high level of cargo security through close corporation with importers, carries and manufacturers. CTPAT imposed some strict requirements, in order to be accepted into CTPAT, your company must be able to meet these security requirements. On other hand, it provides many benefits such as faster transports of your good across the border, potential for more business and improves the internal process etc. If you have any CTPAT issues or questions please contact with us.