Simplify Your Quality Management Procedures with Pharma QMS

ISO 9001 is an internationally recognized standard for Quality Management System (QMS).

This is a generic standard that specifies requirements to implement the quality of the products and services.

This standard consistently improves the quality and also ensures the continual improvement of the Quality Management System.ISO 9001:2015 is the current standard, developed to maintain the overall quality performance of an organization.

This latest standard provides industries’ best practices to enhance the product quality and services and to improve the efficiency of processes.

This is a well-designed standard that helps the organizations meet the statutory and regulatory requirements.

Also, the ISO 9001:2015 standard provides necessary requirements to satisfy the customers’ expectations.IAS provides ISO 9001 Certification in Kuwait and also in various countries such as India, Philippines, Bangladesh, Oman, Singapore, Malaysia, Indonesia, Thailand, Saudi Arabia, UAE, Qatar and so on.

Show your organizations ability by providing high-quality products and services to customers/stakeholders with the ISO 9001 Certification Colombia.

Call us to get certified!ISO 9001 Certificacion

QMS automates all your regulatory compliance and quality tasks in a single, easy-to-use solution.

It reduces quality gaps and prevents delays by consolidating all of your company’s regulatory requirements electronically.

It essentially manages complex regulatory compliance standards.

We’ve listed some of the most popular free and open-source QMS software ahead in the article.

China is one of the fastest growing markets for Medical Devices where the demand for devices is majorly met through exports.

National Medical Products Administration (NMPA) (formerly CFDA) and Centre for Medical Device Evaluation (CMDE) is responsible for the review of the medical device import registration applications of all 3 classes of devices (Class I, II & III).

Class II and III devices require clinical data from NMPA accredited labs whose approval can take up to 2 years.

While aiming at Chinese market entry, applicants should ensure that the key documents are duly attached to get approvals within the review timelines.

Some of the documents and review timelines include:

Freyr supports client to obtain various certifications and to compile other documentation that leads to market approval within strict timelines.

Summary

S. No	Regulatory Parameter	China
1	Regulatory Authority	CFDA
2	Regulation	State Council Order No.650
3	Risk Classification	Class I
		Class II
		Class III
4	Regulatory Pathway	Class I	Notification
		Class II & III	Registration
5	Authorized Representative	China Agent required
6	Fee payable	Class I	No Fee
		Class II	~ $34,000*
		Class III	~ $ 48,000*
7	QMS Requirement	YY/T0287-2017
		ISO 13485
8	Assessment of Technical Data	Center for Medical Device Evaluation (CMDE)
9	Validity of License	Class I	Unlimited
		Class II & III	5 Years
10	Labelling Requirements	Decree No.6 of CFDA
11	Submission format	Paper
12	Final Outcome	Class I	Notification
		Class II & III	Registration Certificate
13	Timelines	Class I	3 -6 months
		Class II	1 - 2 years
		Class III	More than 2 years
14	Language	English & Chinese

*The price is as per records at the time of documentation and is subject to change.

Process Flow

To know more about NMPA’s drug regulations and the local Regulatory assistance, reach out to us at [email protected]

The efficient quality management system software features internal quality policies and SOPs (standard operating procedures).

It is designed to help coordinate and align business activities of a company to uphold the customer and regulatory requirements though focusing on enhancing the performance and effectiveness on a continuous basis.

There are a number of concerns about how beneficial QMS is to the company and the steps involved in implementing the software.

Quality management software focuses on addressing the complex product development lifecycle.

It aims for various highly regulated industries including biotech, pharmaceutical, and medical equipment manufacturing firms.

The IRCA ISO 9001 Lead Auditor Training will assure you to achieve continuous success with QMS as you start working on it.

The QMS Lead Auditor Training course provides in-depth knowledge on quality management system auditing