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Medical device regulatory strategy: Product development and product registration in Asia and globally
| Content Provider | Scilit |
|---|---|
| Author | Ng, May Ng, Martin Soh, Ray Yunos, Fadzlon Hsu, Stephen |
| Copyright Year | 2018 |
| Description | Regulatory strategy is an important planning that helps the company to understand the regulatory requirement, the required resources, and the estimated timeline to register and seek approval from the local authority of the countries of interest. Some countries have abridged or shorter time application routes for a medical device with approval from the benchmark reference agencies and/or a medical device with significant clinical benefit for the patient population example, innovative products, specific clinical diagnosis, and treatment products. Regulatory strategy should be prepared whenever the company is developing a new product or modifying a current registered product. Each country has its registration route or conformity assessment route for the manufacturer to demonstrate that the product meets the safety and performance requirement before it can be imported and/or placed in the market. The technical documentation consists of information on how the medical device was designed, developed, and manufactured. Book Name: Handbook of Medical Device Regulatory Affairs in Asia |
| Related Links | https://content.taylorfrancis.com/books/download?dac=C2018-0-77400-9&isbn=9780429504396&doi=10.1201/9780429504396-5&format=pdf |
| Ending Page | 41 |
| Page Count | 7 |
| Starting Page | 35 |
| DOI | 10.1201/9780429504396-5 |
| Language | English |
| Publisher | Informa UK Limited |
| Publisher Date | 2018-03-28 |
| Access Restriction | Open |
| Subject Keyword | Book Name: Handbook of Medical Device Regulatory Affairs in Asia Computer Science Safety Medical Device Registration Product Conformity Manufactured Treatment Regulatory Strategy |
| Content Type | Text |
| Resource Type | Chapter |
