China

Malaysia

Two main agencies in China regulate medical devices:

1. State Food & Drug Administration (SFDA)

• Chinese equivalent of the U.S. FDA

• All imported medical devices must obtain registration certificate from SFDA

2. General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ)

• Conducts mandatory safety registration, certification, and inspection for certain devices

The following are the updated Registration Requirements as of March 22, 2005.

The following should be submitted to SFDA  (in Chinese and English)

1. SFDA registration form

2. Legal Production Qualification (e.g., US FDA registration)

3. Business license for the Chinese agent registering the product

4. Marketing approval from government of country of origin

5. Product Standards (ISO, CE, AAMI, etc.)

6. Operation Manual

7. Test report issued by SFDA-certified test center (only for Class II and III products that have not received ISO9000 certification)

8. Clinical trial report (only required for certain types of devices)

9. Quality guarantee letter (certifying that the product being registered and sold in China is identical to product approved in country of origin)

10. Authorization letter to a Chinese agent, responsible for reporting adverse events accrued in China

11. After-sales authorization

12. Self-guarantee declaration

Device Registration Process

• Company drafts specifications, submits samples for testing

• Testing center conducts tests based on company’s submitted specifications

• After testing, company submits whole dossier to SFDA

• SFDA sends dossier to Medical Device Evaluation Center (MDEC)

• MDEC reviews specifications, dossier, government certificate, and clinical report

• MDEC sends conclusion to SFDA

• SFDA awards import license if no supplement dossier requested

• Previous regulations did not have specific requirements for clinical trials, just on what kind of devices required trials in China. Under new regulations, all clinical trials for medical devices must follow Good Clinical Practices (GCP).

• Clinical center/hospital selected for trial must be on SFDA approved list.

• Medical Device Clinical Trial Regulation issued by SFDA in early 2004, became effective in April 2004

• Regulation gives detailed requirements for clinical protocol, clinical hospitals, and clinical reports

The Malaysian government has long considered developing a regulatory system to cover medical devices. The Ministry of Health (MOH) is responsible for developing and implementing a regulatory framework to control medical devices. The aims of Malaysia’s medical devices regulation are:

• To protect public health and safety

• To allow patients for earlier access to new technology for early detection, diagnosis and treatment

• To facilitate trade and invigorate the medical devices industry In February 2005, MOH launched their regulatory system, announcing the creation of a voluntary registration system for medical device establishments. Details about this system, called MeDVER (Voluntary Registration Scheme for Medical Devices Establishments), were announced in January 2006, with the following objectives:

• To familiarize all affected parties with the registration process

• To gauge the readiness of medical devices establishments in conforming to the regulatory requirements

• To prepare a smooth transition into the mandatory phase before the full enforcement of medical devices regulation

• To obtain a profile of the Malaysian medical devices industry This is a confidence building stage whereby establishments dealing with medical devices in Malaysia are encouraged to register their establishments and the devices with (MeDVER).

MeDVER is the voluntary registration scheme for medical devices establishments in Malaysia. It is a web-based registration system. All applications shall be made on-line. It consists of 2 parts. Part 1 is an account creation system. Part 2 requests for information pertaining to medical devices establishments with respect to company profile, person responsible, medical devices particulars and pre and post-market details.

MeDVER is not an approval system. Assignment of submission number and registration number does not in any way constitute an admission or agreement by the Ministry of Health Malaysia to denote approval of an establishment and its devices.

The MeDVER website

(http://www.medicaldevices.gov.my/portal/web/)indicates that all applications must be accompanied by relevant supporting documents (as required), and authenticity verification of submitted documents may be necessary with the issuing authority or organization. The website also claims security and encryption features have been incorporated in this registration system to protect the confidentiality of the information provided.

Manufacturers, importers, exporters, distributors and vendors are included in the voluntary registration program. The Ministry of Health notes that the MeDVER system does not denote approval of either a medical device establishment or its products.

The medical device regulatory environment of various Asian countries like Korea, Japan, Philippines, Singapore & Taiwan is available at medicalplasticsindia.com.