Service Introduction

As a medical device product, as a product that must be approved by the government, its marketing authorization is a complicated process. With the reform of medical device regulations and the intensive release and implementation of supporting documents, the registration requirements for medical device products are becoming more and more strict, and the complexity is relatively increased. Therefore, as a medical device enterprise, we must pay attention to the planning of its registration process to avoid repeated investment, change, and even failure, which will bring economic losses, time delays and devastating blows to the enterprise. Therefore, enterprises need to make full plans before joining the production of medical devices to avoid unnecessary losses.

  Service Content

The planning services of the registration scheme mainly include the following aspects:

1. Product classification and identification as well as regulatory requirements and process environment requirements related to pre-registration (or related development products), involving product production environment construction requirements;

2. The distinction of product models and specifications involves the division of product registration units, avoiding repeated submission and withdrawal of registration materials, or forcing unit division;

3. Relevant requirements of national and industry standards for pre-registered products, involving the configuration of production and inspection equipment;

4. Whether the clinical and product clinical requirements are exempted, involving the company's capital budget and investment;

5. The planning of product function, performance and intended use, involving the market advantages and selling points of the product after it goes on the market, so as not to be punished by the administrative supervision department because the product sold does not conform to the registered product;

6. The registration information must be authentic and effective, and the non-compliance caused by the registration verification, daily supervision and random inspection, unannounced inspection and supervision and random inspection of the administrative supervision department will bring unnecessary trouble to the operation of the enterprise;

7. The effective operation of the quality system, regardless of registration system assessment, daily supervision and inspection, unannounced inspection, etc., requires the establishment of a quality management system and effective operation. Quality management system is the foundation of medical device manufacturing enterprises.

8. The product registration plan planning also includes: classification and definition application, innovation application, priority approval, factory site selection, factory design, purification workshop decoration, exemption from clinical judgment and other services.

  prepare materials

1. Provide product instructions (at least include: product photos, model specifications, structural principle characteristics, performance parameters, material characteristics, sterilization methods (aseptic application), comparison of domestic and foreign products on the market, etc.).

2. Information on main raw materials (source, preparation, quality control indicators of main raw materials, or quality standards provided by suppliers, factory inspection reports, and quality inspection data after the arrival of raw materials);

3. Product performance indicators and inspection methods, functional modules, intended use; comparison with the products in the catalog;

4. The production process is provided (the specific production process of the main components of the process flow chart (the main control points must be indicated, that is, the key process and the special process)).

Service Introduction

According to the relevant regulations of the national NMPA, the applicant for medical device registration shall formulate product technical requirements according to the performance indicators and inspection methods of the finished medical device. , submit product technical requirements and other registration application materials. In terms of regulatory regulations, medical device manufacturers should organize production in strict accordance with the registered or filed product technical requirements to ensure that the medical devices that leave the factory meet the mandatory standards and registered or filed product technical requirements.

  Service Content

Huaguang Taihe provides professional and technical personnel with counseling services for the preparation of technical requirements for medical device products, mainly in the following aspects:

1. According to product classification and functional principles, provide technical requirements compilation basis standards, regulatory consultation and guidance;

2. Senior experts provide one-on-one guidance for enterprises to prepare product technical requirements;

3. Thousands of technical requirement templates are provided to save time to market for enterprises;

4. Avoid delays in product registration and listing due to the supplementary product technical requirements during the registration process.

  prepare materials

1. Provide product instructions (at least include: product photos, model specifications, structural principle characteristics, performance parameters, material characteristics, sterilization methods (aseptic application), comparison of domestic and foreign products on the market, etc.).

2. Information on main raw materials (source, preparation, quality control indicators of main raw materials, or quality standards provided by suppliers, factory inspection reports, and quality inspection data after the arrival of raw materials);

3. Product performance indicators and inspection methods;

4. The production process is provided (the specific production process of the main components of the process flow chart (the main control points must be indicated, that is, the key process and the special process)).

Service Introduction

The registration information writing service is one of the core businesses of Huaguang Taihe. Huaguang Taihe has more than ten years of experience in writing registration work for different products, and has accumulated a variety of product registration copywriting experience. Regardless of document logic, regulations and standard requirements, the expression of technical requirements, document compliance, etc., it can provide enterprises with accurate and suitable professional services.

  Service Content

The services are provided as follows:

1. According to product classification and functional principles, provide product registration standards, regulatory consultation and guidance;

2. Guidance service for writing clinical evaluation report in product registration data;

3. Senior experts provide one-on-one guidance for the preparation of product registration materials for enterprises;

3. Multiple sets of product registration templates are provided to save product registration time for enterprises;

4. Reduce the time of product registration and listing due to the problem of writing product information in the registration process;

5. Compilation of registration materials for on-site counseling of enterprises, on-site consulting and services for issuing and supplementing.

  prepare materials

1. Product specification (at least: product photos, model specifications, structure, principle, mechanism of action, source basis of performance parameters, material characteristics, sterilization method and sterilization verification).

2. Product inspection report (performance, microorganism, biocompatibility and other inspection reports (including key material inspection reports when applicable);

3. Compare the product instructions, registration certificate and relevant information of technical requirements (applicable to exempted clinical practice); clinical comparison of similar products should provide corresponding certificates in accordance with regulations;

4. Key process verification materials, such as sterilization verification, packaging verification and other verification materials required by regulations;

5. Verification materials such as product validity period verification and transportation verification;

6. Proof of production site, tooling, equipment and inspection equipment list and measurement, personnel information, etc.

Service Introduction

Registration inspection/entrusted inspection service:

Provide enterprise service support in the formulation and preparation of product technical requirements, sample preparation and testing acceptance, sample rectification, and report tracking. Follow the laws and regulations promulgated by relevant regulatory agencies, as well as the real product information provided by the company for guidance.

  Service Content

The service can provide the following services in test planning, time arrangement, sample quantity requirements, data preparation, etc.:

1. Planning of sample quantity preparation and production quantity planning (sterile, implanted and IVD products involve sample retention, inspection, re-inspection, inspection after expiration date, etc.;

2. Guidance for the preparation of product instruction manuals and product technical requirements;

3. Preparation of product technical documents for inspection;

4. Preparation of product accessories (key components);

5. Precautions for inspection of instruments and equipment, configuration requirements of key components;

6. Product sampling and sample delivery requirements, and go through relevant procedures.

Each province and city has different requirements for product inspection, and the specific implementation refers to the requirements of local regulatory authorities.

  prepare materials

1. Product manual;

2. Quantity of product inspection, testing, sample retention requirements (if applicable), etc.;

2. Send for inspection or sampling samples, product accessories (if necessary);

3. Product technical requirements;

4. Product technical documents, R&D process documents or records (if necessary).