1. Medical device quality system consultation: medical device quality management system establishment, operation guidance, internal audit, pre-audit (a pre-audit will be given after the establishment of the system service project) services (according to the standards ISO13485, ISO9001, ISO14971 and other standards, enterprises can according to demand selection based on criteria);

2. Quality system consulting services under the registrant system: The implementation of the registrant system provides good opportunities for R&D enterprises and talents. As well as system consulting and trusteeship services, we have formulated practical solutions, including the quality requirements of both parties, the connection between enterprises and industrial parks or production enterprises, and the suitability assessment of production environments, so as to save time and costs for enterprises to the greatest extent, and make enterprises run smoothly. Pass the NMPA assessment, obtain product registration and production license, and create benefits for the enterprise.

3. Medical device quality management system simulation unannounced inspection audit service: dispatch senior professional auditors to plan the inspection plan in accordance with the "Measures for Unannounced Inspection of Drugs and Medical Devices", and according to the "Quality Management Practice for Medical Device Production - On-site Inspection Guidance" applicable to the company's products According to the requirements of the "Principles", review the whole process of key products or products required by the company, evaluate the ability of the company's personnel to meet the review and business capabilities, provide a summary list of non-conforming items after review, and guide the company to complete the rectification of non-conforming items as needed. .

4. Internal audit services: Huaguang Taihe provides internal audit services to evaluate customers' management systems. Review the organizational structure and operation structure of the client company to check whether it meets the relevant standard requirements. Document the results in the report while highlighting opportunities for improvement to ensure that the organization is more effectively prepared for regulatory system assessments or unannounced inspections.

5. Supplier / Trustee Assessment (Second Party Audit): Supplier audit services include a detailed analysis of the entire supply chain, ensuring that it is always open and transparent to the company and customers. A second-party audit service assesses whether the supplier/trustee complies with established requirements. Identifying gaps and refining opportunities is critical for professional supplier management. Supplier auditing services can provide valuable support in selecting and evaluating existing and new suppliers/trustees.

6. Long-term entrusted services: Provide customers with long-term technical support services that meet regulatory requirements based on customer needs, including the training of quality management teams, daily regulations/standards training, annual internal audit and management review support, annual self-examination report support, etc. The service of the mode can be selected and customized according to the needs. Ensure that the company continues to meet regulatory requirements and improve the overall operating efficiency of the company.

7. Key audit + others: Huaguang Taihe provides key audit services in the fields of medical device compliance and service quality. Using a proven study design, we conduct a bespoke focused audit based on the client's mandated scope of investigation. Our focused audit work is supported by multiple technical and industry experts.

8. Government-entrusted audit: The quality management system is an important guarantee for medical device manufacturers to obtain a marketing license (obtain a registration certificate and a production license) and maintain the long-term validity of the certificate. It is an important part of NMPA's daily supervision and inspection and unannounced inspections. , an effective basis. Quality system service is one of the company's core services. The system professional teachers have many audit experiences and long-term experience in accepting NMPA assessments.

1. EU MDR/IVDR system consulting technical services, identifying companies selling medical devices to the EU, must meet the requirements of EU Regulation MDR (EU) 2017/745, Class I (sterile/with measuring function/reusable), Class IIa, Before the Class IIb and Class III medical devices are put on the EU market, they must first obtain CE certification and pass the ISO13485 system certification of the notified body.

2. Combined with the company's products and international regulatory requirements, as well as domestic regulatory requirements, provide services such as establishment, training, operation guidance, pre-audit, etc., so that the established system can meet domestic regulations (Quality Management Specification for Medical Device Production, Applicable Appendices and Inspections for Products) Guidelines) requirements, while meeting international certification requirements. Save business operating costs and resources.

3. Provide professional services for customers in the entire supply chain in the complex medical device market, helping them successfully put products on the market and deliver them to users quickly and accurately. We provide manufacturers and their suppliers with comprehensive solutions related to professional coaching, training and certification.

4. The professional medical technology team covers key cities in the medical industry in North China, East China and South China, covering active, passive aseptic, implantable, independent software (including AI) and in vitro diagnostic devices and other products, and has access to the EU market Extensive experience in regulations. At the same time, sufficient experts and extensive geographical coverage reduce service cycles and service costs, and overall control quality. Whether it is pre-regulatory training or post-factory audit, customers can obtain legal and technical services from Huaguang Taihe medical team at the first time.

Provide medical device regulations training, medical training courses tailored to customer needs, to meet customer requirements for understanding and implementation of regulations. This, combined with the certification audit and physical examination (domestic) projects, is one of the important businesses of Huaguang Taihe Medical Device Professional Services.

1. For medical devices sold to the United States, the U.S. Food and Drug Administration (FDA) is regulated by the Federal Food, Drug, and Cosmetic Act, the highest legal document on medical device management. The regulations required by the quality system of medical device enterprises, namely Quality System Regulation, referred to as QSR or QSR820.

2. The establishment of the QSR820 quality system, the establishment of a targeted system or the establishment of a quality system that meets the requirements of multiple parties in combination with the requirements of the company's sales channels (domestic compliance with the "Quality Management Practice for Medical Device Production" and ISO13485 requirements; EU compliance with the requirements of MDR/IVDR regulations Quality system), services include writing system documents or reviewing the medical device quality system that the company has currently established, putting forward rectification opinions according to the audit results, and improving the existing system to meet the requirements of FDA QSR 820, US FDA 21CFR 820 QSR820 quality system regulatory guidance , Simulated FDA QSR820 factory audit, US FDA 21CFR 820 QSR820 audit site escort, US 21CFR Part 11 electronic signature regulatory compliance consultation.

3. Provide long-term follow-up review services and regulatory support services for enterprises.

4. Introduction of the results of the FDA on-site audit

There are three main results of the on-site audit:

(1) NAI (No Action Indicated), no further measures; indicating that no defects or only very minor defects were found in the on-site audit, also called "zero defects";

(2) VAI (Volunteer Action Indicated), voluntary rectification measures; indicating that minor defects were found in the inspection process;

(3) OAI (Official Action Indicated), official measures; if serious defects are found during the inspection process, FDA must take measures to ensure that manufacturers can meet the requirements of regulations.

There are serious non-conformance consequences:

(1) Raise an import alert or warning letter on the spot

(2) For foreign manufacturers, all products will be automatically detained when they arrive at the U.S. Customs; global notice!

(3) If the factory inspection of the FDA is rejected, or the factory inspection finds a problem that is not in line with the QSR, which is considered by the FDA to be serious, all the products of the factory will be regarded as "counterfeit and shoddy".

1. The Medical Device Single Audit Program MDSAP (Medical Device Single Audit Program (MDSAP) is a project jointly initiated by members of the International Medical Device Regulators Forum (IMDRF). A single audit can meet the different QMS/GMP requirements of participating countries. The project has been approved by five regulatory agencies, FDA, Health Canada, Australian Therapeutic Goods Administration (Chinese abbreviation) TGA, Brazil Recognized by the Health Bureau ANVISA and the Japanese Ministry of Health, Labour and Welfare MHLW, and officially implemented MDSAP and mutual recognition of inspection results on January 1, 2017. Currently, China and the European Union join the project as observers, and the World Health Organization also acts as an observer officially joined.

2. Assist enterprises to establish a medical device quality management system in accordance with MDSAP, quality system document writing, quality system training, operation guidance, internal pre-audit services, or assist enterprises to meet the requirements of MDSAP in the original quality management system and integrate the quality management of enterprises System, meet the requirements of national regulations, and provide training services for MDSAP special regulations. It is also possible to combine Chinese regulatory requirements and EU regulatory requirements according to the needs of enterprises (domestic compliance with the "Quality Management Practice for Medical Devices" and ISO13485 requirements; EU quality system in compliance with MDR/IVDR regulations) to integrate a complete set of quality that meets the requirements of multinational regulations system, as well as quality system document writing, quality system training, operation coaching, and internal pre-audit services.

3. Provide long-term follow-up review services and regulatory support services for enterprises.

4. MDSAP Certification FAQ

1) What kind of companies can apply for MDSAP certification?

A: Both manufacturing and operating medical device companies can apply.

2) What are the requirements for enterprise qualifications?

A: Enterprises need to have a business license approved by the industrial and commercial administration. There are no clear mandatory requirements for domestic registration certificates or other product certificates, and whether ISO13485 certification has been done is not all mandatory requirements. Different certification agencies will have slightly different specific operational requirements. For example, some agencies require ISO13485 certificates to be MDSAP Issued by the auditing agency, some agencies do not have this requirement, as long as it is certified according to the ISO13485 standard.

3) Will the trading company review the supplier if it applies?

A: Generally, it is not necessary. During the audit, we will pay attention to supplier management and review documents to confirm whether the supplier meets the requirements of MDSAP. If the audit problem is too large, we may go to the site to audit the supplier.

4) Is Dun & Bradstreet coding necessary?

A: MDSAP official requirements must provide. Different certification bodies operate slightly differently.

5) Does the application country have to be 5 countries?

A: 5 countries is not a mandatory requirement. However, it is worth noting that if the enterprise has not exported any products to these 5 countries before applying for MADSAP, the number of countries to apply for certification can be selected according to the needs of business development. If the business has exported to one or more of these countries or is locally registered, this country must apply.

6) What is the basis of the MDSAP audit?

A: The audit is based on the relevant laws and regulations of medical devices in various countries, which are as follows:

United States: 21 CFR Part 820/21 CFR Part 821/21 CFR Part 803, 806, 807

Canada: Medical Device Regulations - Part 1 - SOR 98/282

Australia: Therapeutic Goods Regulations, 2002, Schedule 3 Part 1 (excluding 1.6) - Full Quality Assurance Procedure/Therapeutic Goods Regulations, 2002, Schedule 3, Part 4- Production Quality Assurance Procedure

Brazil: RDC ANVISA N. 16/2013, 23/2012, 67/2009

Japan: MHLW MO169/ PMD Act

7) How long is the MDSAP certification process and certificate valid?

The MDSAP certification process is the same as the quality management system certification process. First, the system is planned and then run to the application review. MDSAP is the same as the initial audit of the conventional system certification, which is audited in one or two stages. After the initial audit, the certificate is valid for three years, and a surveillance audit is required every year, followed by a re-certification audit in the third year.

8) What is the cost of certification related to?

A: The cost of certification is related to the country of application, regulatory requirements, product process and the number of sites. Unlike the conventional system, the number of people has little effect on the cost of certification.

9) How long does the certification cycle take?

A: Usually, the counseling time takes 3-6 months according to the actual situation of the enterprise, and the certification cycle is about 5-6 months from the application to the final certificate issuance.