GMP of medical devices

The purpose of medical device GMP is to start from 2011101.

Officially implemented, enterprises that fail to meet the standards after July 20 1 1 will not be registered. GMP is the abbreviation of English Good Manufacturing Practice.

Good Chinese means "good working norms" or "good manufacturing norms and good manufacturing standards", which is a standard that pays special attention to ensuring production in the production process.

Product quality and safety management system.

20 10 10 October 22nd

On, the US Food and Drug Administration in Shenzhen held the "20 10 Supervision Meeting for Medical Device Manufacturers in Shenzhen".

The mobilization meeting for work and implementation of the Standard is the first meeting of the medical device industry. China's medical device industry is developing very rapidly, and more and more products enter the market, which has a great impact on the safety of medical devices.

Validity puts forward higher and higher requirements. Therefore, it is an inevitable choice under the new situation to strengthen supervision, encourage the advanced and eliminate the backward. Through the implementation of GMP for medical devices, the entry threshold is gradually raised and strict daily supervision is carried out.

While managing and ensuring the safety and effectiveness of enterprise products, we will gradually eliminate a number of scattered, chaotic and poor products, promote enterprises to improve their management level, adapt to international rules, and make outstanding enterprises bigger and stronger. Improve the management standards of medical device production and China.

International integration is the only way for China medical device enterprises to base themselves on their own land and actively move towards the world.

ISO9000:

ISO (International Organization for Standardization) and IAF (International Accreditation Forum) issued a joint communique on August 20, 2008 (the year of the fifth year), agreeing to smoothly transform the most widely used quality management system standards in the world and implement ISO900 1:2008 certification.

Based on the eight-year practice of about 1 10,000 organizations in 170 countries around the world, the standard of Lao O900 1:2008 clearly expresses the requirements of ISO900 1:2008 and strengthens the connection with ISO 140066.

It is planned to adopt the international standard ISO900 1 "Quality Management System Requirements" in 2008.

GB/T was released at the end of 2008.

1900 1-2008 quality management system requirements. 1 years ago, after the release of the ISO900 1:2008 standard, the certificates issued by all recognized certification bodies were

ISO900 1:2008 certification; The full name of internal auditor is internal quality system auditor, who is usually familiar with ISO900 1:2008 international standards and enterprise management. According to the requirements of the new ISO900 1:2008 standard, any organization implementing the new ISO900 1:2008 standard needs to conduct internal quality audit at least once a year. Therefore, any organization that implements ISO900 1:2008 usually needs to train a group of internal auditors. Internal auditors can be part-time staff in various departments, so internal auditors play an important role in the normal operation and improvement of the quality system in an organization.

Quality is the key to success. Research conducted by different governments, international organizations and trade associations.

It shows that the survival, development and continuous progress of enterprises depend on the effective implementation of quality assurance system. International Organization for Standardization (ISO)

The 9000 series quality system has been widely adopted by 1 10 countries in the world, including developed and developing countries, which makes the market competition more intense and the quality of products and services increasingly improved. As it turns out,

Effective quality management is one of the means to win in the fierce market competition.

Today, ISO9000 series management standards have been accepted and recognized by all walks of life providing products and services, and having a quality management system widely recognized by countries and society all over the world has great market advantages. In the next few years, when the market economy at home and abroad develops further and trade barriers are eliminated, it will become more important.

The establishment of ISO9000 quality assurance system can make enterprises and organizations realize the following benefits:

1) A well-structured quality management system makes the operation of the organization produce greater benefits and higher efficiency.

2) Better training and higher productivity.

3) reducing customers' rejection and complaints can save a lot of money and eventually enjoy a larger market share;

4) Customers trust the enterprise and its products/services more.

5) it can be unimpeded in the market that needs ISO9000 certification.

ISO 13485:

The full name of ISO 13485: 2003 standard is the legal requirement of medical device quality management system. This standard is formulated by SCA/TC22 1 Technical Committee for Standardization of Medical Device Quality Management and General Requirements, and is an independent standard based on ISO900 1:2000: 2000. This standard specifies the quality management system requirements of relevant organizations, but it is not the implementation guide of ISO900 1 standard in medical device industry.

Since the publication of 1996, this standard has been widely implemented and applied in the world. The new ISO 13485 standard was officially released on July 3rd, 2003. Different from the ISO900 1:2000: 2000 standard, ISO 13485: 2003 is a management standard suitable for the regulatory environment: from the name, it is obviously the requirement of a regulatory quality management system. Medical devices are not only common commodities in the international business environment, but also subject to the supervision and management of national and regional laws and regulations, such as FDA in the United States, MDD (European Medical Device Directive) in the European Union, and Regulations on the Supervision and Administration of Medical Devices in China. Therefore, the standards must be bound by laws and run in a regulatory environment. At the same time, the risks of medical device products must be fully considered, and risk management is required in the whole process of medical device product realization. Therefore, apart from special requirements, it can be said that ISO 13485 is actually ISO900 1 in the medical device supervision environment.

The United States, Canada and Europe generally take ISO 900 1, EN 4600 1 or ISO 13485 as the requirements of quality assurance system, and the establishment of medical device quality assurance system is based on these standards. To enter the markets of different countries in North America, Europe or Asia, medical devices should meet the corresponding regulatory requirements.