Accredited Conformity Assessment Supporting the Medical Device Sector in the APAC region

A summary of this article :

As the medical device industry expands globally, including in the Asia Pacific region, the demand for safe medical device products is increasing. So a conformity assessment and accreditation has become essential in the health sector.

Many standards are applicable, including ISO 15379, ISO 13485, ISO/IEC 17021, ISO 20387, ISO/IEC 17065. In addition, implementation of conformity assessment and the regulations in the Asia Pacific region differ from country to country.

• •  Japan : Complying with the Pharmaceutical and Medical Device (PMD) Act.
• •  Australia : its own national standard orders, the international ISO standards can be used.
• •  Malaysia : the Medical Device Authority under the Ministry of Health is the key regulatory body
• •  United States : FDA, Accreditation Scheme for Conformity Assessment – ASCA Pilot Program

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Implementation of different regulatory practices in the region leads to difficulties at the manufacturer’s end while exporting or importing products. To reduce technical barriers to trade, it is critical that a common standardised practice is implemented by the region with respect to conformity assessment requirements.

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<Accredited Conformity Assessment Supporting>